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Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients (VA ROBOTICS)

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ClinicalTrials.gov Identifier: NCT00372411
Recruitment Status : Completed
First Posted : September 7, 2006
Results First Posted : January 13, 2014
Last Update Posted : January 13, 2014
Sponsor:
Collaborator:
Burke Medical Research Institute
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Stroke
Interventions Device: Robot-Assisted Therapy - MIT-MANUS System
Other: Intensive Comparison Therapy
Other: Usual Care
Enrollment 127
Recruitment Details Between 11-8-06 and 10-31-08, 200 were screened and 127 randomized from 4 VA medical centers: Gainesville, West Haven, Baltimore, and Seattle. Usual care enrollment was stopped after 15 months when target information was attained per protocol. Recruitment to the robot-assisted and intensive comparison groups continued for 24 months.
Pre-assignment Details  
Arm/Group Title Robot-assisted Therapy Intensive Comparison Therapy Usual Care
Hide Arm/Group Description Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block. Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training. Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
Period Title: Overall Study
Started 49 50 28
Completed 44 42 25
Not Completed 5 8 3
Reason Not Completed
Withdrawal by Subject             3             4             1
Death             0             2             1
Lost to Follow-up             1             1             1
Adverse Event             1             1             0
Arm/Group Title Robot-assisted Therapy Intensive Comparison Therapy Usual Care Total
Hide Arm/Group Description Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block. Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training. Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center. Total of all reporting groups
Overall Number of Baseline Participants 49 50 28 127
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 50 participants 28 participants 127 participants
66  (11) 64  (11) 63  (12) 65  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 50 participants 28 participants 127 participants
Female
2
   4.1%
2
   4.0%
1
   3.6%
5
   3.9%
Male
47
  95.9%
48
  96.0%
27
  96.4%
122
  96.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 50 participants 28 participants 127 participants
Hispanic or Latino
1
   2.0%
2
   4.0%
0
   0.0%
3
   2.4%
Not Hispanic or Latino
48
  98.0%
48
  96.0%
28
 100.0%
124
  97.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 50 participants 28 participants 127 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   2.0%
0
   0.0%
1
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  20.4%
12
  24.0%
5
  17.9%
27
  21.3%
White
38
  77.6%
35
  70.0%
23
  82.1%
96
  75.6%
More than one race
1
   2.0%
2
   4.0%
0
   0.0%
3
   2.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants 50 participants 28 participants 127 participants
49 50 28 127
Index Stroke Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants 50 participants 28 participants 127 participants
Hemorrhagic 7 6 6 19
Ischemic 42 44 22 108
Index Stroke Location  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants 50 participants 28 participants 127 participants
Anterior circulation ≥1/3 of hemisphere 6 14 6 26
Anterior circulation <1/3 of hemisphere 17 21 10 48
Small deep infarct 17 15 6 38
Posterior circulation 9 0 6 15
Time from Index Stroke to Randomization  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 50 participants 28 participants 127 participants
3.6  (4.0) 4.8  (4.0) 6.2  (5.0) 4.7  (4.2)
Fugl-Meyer Assessment   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 49 participants 50 participants 28 participants 127 participants
19.7  (10.7) 17.3  (8.4) 20.3  (9.0) 18.9  (9.5)
[1]
Measure Description: Primary outcome baseline scores
Comorbidity Disease Index   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants 50 participants 28 participants 127 participants
≤1 Domain 7 7 2 16
2 Domains 13 24 8 45
≥3 Domains 29 19 18 66
[1]
Measure Description: The Comorbidity Disease Index domains include cardiac, respiratory, neurologic, musculoskeletal, general (mental or emotional problems and sleep or pain disorders), cancer, diabetes, and visual problems. The domain scores are totaled to create an overall comorbidity score (≤1, 2, or ≥3 domains).
1.Primary Outcome
Title Fugl-Meyer Assessment for Motor Recovery (FM) Scale
Hide Description Fugl-Meyer (FM) is a standard instrument for the quantitative clinical assessment of motor impairment and function. In this study the upper extremity subsection of the FM was used. The FM assesses several impairment dimensions by using a 3 point ordinal scale: 0 = cannot perform, 1 = can perform partially and 2 = can perform fully. These measures are summed to an overall score is Scoring for upper extremity FM ranges from 0 (worst, completely plegic) to 66 (best, normal). Higher scores indicate better functioning. Outcome measure is the change in the FM score at 6, 12, 24 and 36 weeks relative to baseline.
Time Frame 6, 12, 24 and 36 weeks minus baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with baseline and follow-up measures were included by intention-to-treat
Arm/Group Title Robot-assisted Therapy Intensive Comparison Therapy Usual Care
Hide Arm/Group Description:
Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
Overall Number of Participants Analyzed 47 46 27
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
6 weeks minus baseline 3.01  (0.92) 3.19  (0.91) -2.08  (1.08)
12 weeks minus baseline 3.87  (1.05) 4.01  (1.06) -1.06  (1.00)
24 weeks minus baseline 4.22  (1.05) 2.75  (1.06) -2.02  (1.14)
36 weeks minus baseline 5.07  (1.18) 2.81  (1.18) -0.53  (1.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Robot-assisted Therapy, Usual Care
Comments Because randomization to usual care was stopped after 15 months as specified by the protocol, comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses
Method ANCOVA
Comments Analysis is of change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline FM value.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.17
Confidence Interval (2-Sided) 95%
-0.23 to 4.58
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Robot-assisted Therapy, Usual Care
Comments Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.
Method Mixed Models Analysis
Comments Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.88
Confidence Interval (2-Sided) 95%
0.57 to 5.18
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Robot-assisted Therapy, Intensive Comparison Therapy
Comments Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses
Method ANCOVA
Comments Analysis is of change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline FM value.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-2.94 to 2.65
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Robot-assisted Therapy, Intensive Comparison Therapy
Comments Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.
Method Mixed Models Analysis
Comments Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.58
Confidence Interval (2-Sided) 95%
-2.97 to 1.81
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Stroke Impact Scale
Hide Description The Stroke Impact Scale (SIS) is stroke specific, self-reported measure that evaluates function and quality of life in eight clinically relevant domains. The domains of hand function, activities of daily living, instrumental activities of daily living, mobility, and social participation were used; total score ranges from 0 to 100 with higher values indicating better functioning. Outcome is change at 6, 12, 24 and 36 weeks relative to baseline.
Time Frame 6, 12, 24 and 36 weeks minus baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robot-assisted Therapy Intensive Comparison Therapy Usual Care
Hide Arm/Group Description:
Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
Overall Number of Participants Analyzed 47 46 27
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
6 weeks minus baseline 5.49  (1.61) 4.08  (1.57) -3.79  (2.47)
12 weeks minus baseline 6.31  (1.68) 5.77  (1.67) -3.03  (2.34)
24 weeks minus baseline 5.58  (1.68) 4.23  (1.69) -0.26  (2.37)
36 weeks minus baseline 5.14  (1.89) 4.97  (1.88) 0.76  (2.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Robot-assisted Therapy, Usual Care
Comments Because randomization to usual care was stopped after 15 months as specified by the protocol, comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses
Method ANCOVA
Comments Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.64
Confidence Interval (2-Sided) 95%
2.03 to 13.24
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Robot-assisted Therapy, Usual Care
Comments Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.
Method Mixed Models Analysis
Comments Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.95
Confidence Interval (2-Sided) 95%
0.34 to 11.56
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Robot-assisted Therapy, Intensive Comparison Therapy
Comments Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.
Method ANCOVA
Comments Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
-3.87 to 4.94
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Robot-assisted Therapy, Intensive Comparison Therapy
Comments Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.
Method Mixed Models Analysis
Comments Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
-2.74 to 5.12
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Wolf Motor Function Test
Hide Description The Wolf Motor Function Test (WMFT) is a functionally-based test designed to provide an objective measure of both proximal (during tasks such as lifting the hand from table to box top) and distal control (grasping pencil, bringing soda can to mouth) of the paretic arm for patients after stroke or traumatic brain injury. The WMFT consists of 17 items, of which 15 measure time to perform functional tasks. The tasks are averaged to produce a score in seconds that ranges from 0 to 120 seconds, with higher scores indicating worse functioning. Outcome measure is the change in the Wolf score at 6, 12, 24 and 36 weeks relative to baseline.
Time Frame 6, 12, 24 and 36 weeks minus baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robot-assisted Therapy Intensive Comparison Therapy Usual Care
Hide Arm/Group Description:
Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
Overall Number of Participants Analyzed 47 46 27
Least Squares Mean (Standard Error)
Unit of Measure: Seconds
6 weeks minus baseline -3.98  (2.72) -3.24  (2.64) 7.38  (2.53)
12 week minus baseline -3.96  (3.00) -4.89  (3.00) 7.54  (2.97)
24 weeks minus baseline -5.97  (2.77) -3.08  (2.74) 8.59  (3.10)
36 weeks minus baseline -6.23  (2.83) -2.66  (2.79) 7.30  (2.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Robot-assisted Therapy, Usual Care
Comments Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.
Method ANCOVA
Comments Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.41
Confidence Interval (2-Sided) 95%
-11.52 to 2.70
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Robot-assisted Therapy, Usual Care
Comments Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.
Method Mixed Models Analysis
Comments Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -8.10
Confidence Interval (2-Sided) 95%
-13.61 to -2.60
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Robot-assisted Therapy, Intensive Comparison Therapy
Comments Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.
Method ANCOVA
Comments Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
-7.03 to 8.89
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Robot-assisted Therapy, Intensive Comparison Therapy
Comments Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.
Method Mixed Models Analysis
Comments Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.13
Confidence Interval (2-Sided) 95%
-9.20 to 4.93
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in the Numeric Rating Scale (NRS) at 12 Weeks Relative to Baseline
Hide Description The Numeric Rating Scale (NRS) for pain is a self report scale ranging from 0 (no Pain) to 10 (pain as bad as you can imagine).
Time Frame 12 weeks minus baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robot-assisted Therapy Intensive Comparison Therapy Usual Care
Hide Arm/Group Description:
Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
Overall Number of Participants Analyzed 47 46 27
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.61  (0.29) 0.24  (0.30) 0  (0.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Robot-assisted Therapy, Usual Care
Comments Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.
Method ANCOVA
Comments Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.81
Confidence Interval (2-Sided) 95%
-1.73 to 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Robot-assisted Therapy, Intensive Comparison Therapy
Comments Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.
Method ANCOVA
Comments Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.84
Confidence Interval (2-Sided) 95%
-1.62 to -0.06
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to Baseline
Hide Description The Modified Ashworth Scale for spasticity is a measurement of spasticity across 9 muscle groups. Each muscle group is scored on a 0 to 5 scale with higher scores indicating worse functioning. The total score is the average score from the 9 muscle groups and ranges from 0 to 5 with higher scores indicating worse functioning.
Time Frame 12 weeks minus baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robot-assisted Therapy Intensive Comparison Therapy Usual Care
Hide Arm/Group Description:
Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
Overall Number of Participants Analyzed 47 46 27
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.07  (0.09) 0.12  (0.09) -0.04  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Robot-assisted Therapy, Usual Care
Comments Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.
Method ANCOVA
Comments Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.25 to 0.26
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Robot-assisted Therapy, Intensive Comparison Therapy
Comments Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.
Method ANCOVA
Comments Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.42 to 0.04
Estimation Comments [Not Specified]
Time Frame Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks
Adverse Event Reporting Description Site personnel inquired about adverse and serious adverse events at each study contact.
 
Arm/Group Title Robot-assisted Therapy Intensive Comparison Therapy Usual Care
Hide Arm/Group Description Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block. Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training. Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
All-Cause Mortality
Robot-assisted Therapy Intensive Comparison Therapy Usual Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Robot-assisted Therapy Intensive Comparison Therapy Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/49 (22.45%)      18/50 (36.00%)      9/28 (32.14%)    
Cardiac disorders       
Cardiac disorder  1  1/49 (2.04%)  1 0/50 (0.00%)  0 0/28 (0.00%)  0
Cardiac failure  1  0/49 (0.00%)  0 1/50 (2.00%)  1 1/28 (3.57%)  1
Cardiac failure congestive  1  0/49 (0.00%)  0 1/50 (2.00%)  2 1/28 (3.57%)  1
Coronary artery occlusion  1  0/49 (0.00%)  0 0/50 (0.00%)  0 1/28 (3.57%)  1
Myocardial infarction  1  0/49 (0.00%)  0 0/50 (0.00%)  0 0/28 (0.00%)  0
Cardiac Disorders  2 [1]  1/49 (2.04%)  2 2/50 (4.00%)  3 3/28 (10.71%)  3
Gastrointestinal disorders       
Pancreatitis  1  0/49 (0.00%)  0 1/50 (2.00%)  1 0/28 (0.00%)  0
Upper gastrointestinal haemorrhage  1  0/49 (0.00%)  0 1/50 (2.00%)  1 0/28 (0.00%)  0
Vomiting  1  0/49 (0.00%)  0 1/50 (2.00%)  1 0/28 (0.00%)  0
Gastrointestinal Disorders  2 [2]  0/49 (0.00%)  0 3/50 (6.00%)  3 0/28 (0.00%)  0
General disorders       
Chest pain  1  1/49 (2.04%)  1 0/50 (0.00%)  0 0/28 (0.00%)  0
Death  1  0/49 (0.00%)  0 2/50 (4.00%)  2 0/28 (0.00%)  0
Drug interaction  1  0/49 (0.00%)  0 0/50 (0.00%)  0 1/28 (3.57%)  1
General Disorders  2 [3]  1/49 (2.04%)  1 2/50 (4.00%)  2 1/28 (3.57%)  1
Hepatobiliary disorders       
Cholecystitis  1  1/49 (2.04%)  2 0/50 (0.00%)  0 0/28 (0.00%)  0
Cholecystitis acute  1  2/49 (4.08%)  2 0/50 (0.00%)  0 0/28 (0.00%)  0
Hepatobiliary Disorders  2 [4]  2/49 (4.08%)  4 0/50 (0.00%)  0 0/28 (0.00%)  0
Infections and infestations       
Cellulitis  1  1/49 (2.04%)  1 0/50 (0.00%)  0 0/28 (0.00%)  0
Localised infection  1  1/49 (2.04%)  1 0/50 (0.00%)  0 0/28 (0.00%)  0
Pneumonia  1  1/49 (2.04%)  2 1/50 (2.00%)  1 1/28 (3.57%)  1
Urinary tract infection  1  1/49 (2.04%)  1 1/50 (2.00%)  1 0/28 (0.00%)  0
Infections  2 [5]  3/49 (6.12%)  5 2/50 (4.00%)  2 1/28 (3.57%)  1
Injury, poisoning and procedural complications       
Ankle fracture  1  0/49 (0.00%)  0 1/50 (2.00%)  1 0/28 (0.00%)  0
Fall  1  2/49 (4.08%)  2 2/50 (4.00%)  2 1/28 (3.57%)  1
Overdose  1  0/49 (0.00%)  0 1/50 (2.00%)  1 0/28 (0.00%)  0
Road traffic accident  1  1/49 (2.04%)  1 0/50 (0.00%)  0 0/28 (0.00%)  0
Injury  2 [6]  3/49 (6.12%)  3 4/50 (8.00%)  4 1/28 (3.57%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Prostate cancer  1  0/49 (0.00%)  0 1/50 (2.00%)  1 0/28 (0.00%)  0
Renal cancer  1  0/49 (0.00%)  0 1/50 (2.00%)  1 0/28 (0.00%)  0
Neoplasms  2 [7]  0/49 (0.00%)  0 2/50 (4.00%)  2 0/28 (0.00%)  0
Nervous system disorders       
Cerebrovascular accident  1  1/49 (2.04%)  1 0/50 (0.00%)  0 1/28 (3.57%)  1
Convulsion  1  1/49 (2.04%)  1 0/50 (0.00%)  0 0/28 (0.00%)  0
Hemiparesis  1  0/49 (0.00%)  0 1/50 (2.00%)  1 0/28 (0.00%)  0
Transient ischaemic attack  1  1/49 (2.04%)  1 1/50 (2.00%)  1 0/28 (0.00%)  0
Nervous System Disorders  2 [8]  2/49 (4.08%)  3 2/50 (4.00%)  2 1/28 (3.57%)  1
Psychiatric disorders       
Aggression  1  0/49 (0.00%)  0 1/50 (2.00%)  1 0/28 (0.00%)  0
Depression  1  0/49 (0.00%)  0 0/50 (0.00%)  0 1/28 (3.57%)  1
Psychiatric Disorders  2 [9]  0/49 (0.00%)  0 1/50 (2.00%)  1 1/28 (3.57%)  1
Renal and urinary disorders       
Nephrolithiasis  1  1/49 (2.04%)  1 0/50 (0.00%)  0 0/28 (0.00%)  0
Neurogenic bladder  1  0/49 (0.00%)  0 0/50 (0.00%)  0 1/28 (3.57%)  1
Urinary tract obstruction  1  0/49 (0.00%)  0 0/50 (0.00%)  0 1/28 (3.57%)  1
Renal and Urinary Disorders  2 [10]  1/49 (2.04%)  1 0/50 (0.00%)  0 2/28 (7.14%)  2
Respiratory, thoracic and mediastinal disorders       
Pulmonary oedema  1  0/49 (0.00%)  0 0/50 (0.00%)  0 1/28 (3.57%)  1
Sleep apnoea syndrome  1  0/49 (0.00%)  0 1/50 (2.00%)  1 0/28 (0.00%)  0
Respiratory Disorders  2 [11]  0/49 (0.00%)  0 1/50 (2.00%)  1 1/28 (3.57%)  1
Social circumstances       
Respite care  1  1/49 (2.04%)  1 1/50 (2.00%)  2 1/28 (3.57%)  2
Social Circumstances  2 [12]  1/49 (2.04%)  1 1/50 (2.00%)  2 1/28 (3.57%)  2
Surgical and medical procedures       
Cardiac pacemaker battery replacement  1  0/49 (0.00%)  0 1/50 (2.00%)  1 0/28 (0.00%)  0
Colon polypectomy  1  0/49 (0.00%)  0 0/50 (0.00%)  0 1/28 (3.57%)  1
Hernia repair  1  0/49 (0.00%)  0 1/50 (2.00%)  1 0/28 (0.00%)  0
Knee arthroplasty  1  0/49 (0.00%)  0 0/50 (0.00%)  0 1/28 (3.57%)  1
Surgical and Medical Procedures  2 [13]  0/49 (0.00%)  0 2/50 (4.00%)  2 2/28 (7.14%)  2
Vascular disorders       
Hypotension  1  0/49 (0.00%)  0 0/50 (0.00%)  0 1/28 (3.57%)  1
Orthostatic hypotension  1  0/49 (0.00%)  0 1/50 (2.00%)  1 0/28 (0.00%)  0
Thrombosis  1  0/49 (0.00%)  0 1/50 (2.00%)  1 0/28 (0.00%)  0
Vascular Disorders  2 [14]  0/49 (0.00%)  0 2/50 (4.00%)  2 1/28 (3.57%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
2
Term from vocabulary, MedDRA (12.0)
[1]
Sum of all adverse event terms in the Cardiac Disorders System Organ Class
[2]
Sum of all adverse event terms in the Gastrointestinal Disorders System Organ Class
[3]
Sum of all adverse event terms in the General Disorders System Organ Class
[4]
Sum of all adverse event terms in the Hepatobiliary Disorders System Organ Class
[5]
Sum of all adverse event terms in the Infections and Infestations System Organ Class
[6]
Sum of all adverse event terms in the Injury, Poisoning and Procedural Complications System Organ Class
[7]
Sum of all adverse event terms in the Neoplasms System Organ Class
[8]
Sum of all adverse event terms in the Nervous System Disorders System Organ Class
[9]
Sum of all adverse event terms in the Psychiatric Disorders System Organ Class
[10]
Sum of all adverse event terms in the Renal and Urinary Disorders System Organ Class
[11]
Sum of all adverse event terms in the Respiratory Disorders System Organ Class
[12]
Sum of all adverse event terms in the Social Circumstances System Organ Class
[13]
Sum of all adverse event terms in the Surgical and Medical Procedures System Organ Class
[14]
Sum of all adverse event terms in the Vascular Disorders System Organ Class
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Robot-assisted Therapy Intensive Comparison Therapy Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/49 (24.49%)      9/50 (18.00%)      0/28 (0.00%)    
General disorders       
Pain, Stiffness, or Soreness  1 [1]  10/49 (20.41%)  23 6/50 (12.00%)  7 0/28 (0.00%)  0
Fatigue  1 [2]  3/49 (6.12%)  6 0/50 (0.00%)  0 0/28 (0.00%)  0
Swelling or Bruising  1 [3]  1/49 (2.04%)  1 1/50 (2.00%)  3 0/28 (0.00%)  0
Cut, Scratch or Irritation  1 [4]  2/49 (4.08%)  2 2/50 (4.00%)  2 0/28 (0.00%)  0
Numbness  1 [5]  2/49 (4.08%)  2 0/50 (0.00%)  0 0/28 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
[1]
Only related adverse event were collected. Pain, stiffness, or soreness collected as a single type of event
[2]
Fatigue related to study therapy.
[3]
Swelling or Bruising collected as one event related to study therapy.
[4]
Cut, Scratch or Irritation related to study therapy collected as one event type.
[5]
Numbness related to study therapy.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Peter Guarino, MPH, PhD, Director, WH-CSPCC
Organization: Dept. of Veterans Affairs, Cooperative Studies Program, West Haven, CT
Phone: 203-932-5711 ext 3780
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00372411     History of Changes
Other Study ID Numbers: 558
First Submitted: September 5, 2006
First Posted: September 7, 2006
Results First Submitted: September 4, 2013
Results First Posted: January 13, 2014
Last Update Posted: January 13, 2014