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Improving Ambulation Post Stroke With Robotic Training

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ClinicalTrials.gov Identifier: NCT00975156
Recruitment Status : Completed
First Posted : September 11, 2009
Results First Posted : September 13, 2012
Last Update Posted : February 25, 2013
Sponsor:
Information provided by (Responsible Party):
Elizabeth Noser, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Stroke
Interventions Other: Physical Therapy
Device: Lokomat
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lokomat Intervention Standard of Care
Hide Arm/Group Description [Not Specified] Conventional physical therapy
Period Title: Overall Study
Started 11 10
Completed 11 9
Not Completed 0 1
Reason Not Completed
Protocol Violation             0             1
Arm/Group Title Lokomat Intervention Standard of Care Total
Hide Arm/Group Description [Not Specified] Conventional physical therapy Total of all reporting groups
Overall Number of Baseline Participants 11 10 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  36.4%
5
  50.0%
9
  42.9%
>=65 years
7
  63.6%
5
  50.0%
12
  57.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 21 participants
66.91  (8.50) 64.33  (10.91) 65.75  (9.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Female
4
  36.4%
4
  40.0%
8
  38.1%
Male
7
  63.6%
6
  60.0%
13
  61.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 10 participants 21 participants
11 10 21
1.Primary Outcome
Title 10-meter Walking Test (10mWT)
Hide Description [Not Specified]
Time Frame Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was determined per protocol (i.e.between-group variation)
Arm/Group Title Lokomat Intervention 10-meter Walking Test (10mWT) Outcome Standard of Care 10mWT Outcome All Participants 10mWT Outcome
Hide Arm/Group Description:
Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
Overall Number of Participants Analyzed 11 9 20
Mean (Standard Deviation)
Unit of Measure: meters per second (m/s)
Baseline 0.20  (0.10) 0.18  (0.12) 0.19  (0.11)
Post-Intervention (mean=5.05 days post-therapy) 0.20  (0.10) 0.27  (0.27) 0.23  (0.19)
Three-Month Follow-up 0.21  (0.10) 0.28  (0.29) 0.24  (0.20)
2.Secondary Outcome
Title 6 Minute Walking Distance (6MWD)
Hide Description [Not Specified]
Time Frame Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lokomat Intervention 6 Minute Walking Distance (6MWD) Outcome Standard of Care 6MWD Outcome All Participants 6MWD Outcome
Hide Arm/Group Description:
Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
Baseline, Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
Overall Number of Participants Analyzed 11 9 20
Mean (Standard Deviation)
Unit of Measure: meters (m)
Baseline 53.94  (30.53) 48.77  (21.04) 51.61  (26.16)
Post-Intervention (mean=5.05 days post-therapy) 57.02  (25.50) 70.26  (60.40) 62.98  (43.86)
Three-Month Follow-up 57.82  (25.99) 76.89  (62.29) 66.40  (45.65)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lokomat Intervention Standard of Care
Hide Arm/Group Description Robotic-assisted gait therapy Conventional physical therapy
All-Cause Mortality
Lokomat Intervention Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lokomat Intervention Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/11 (18.18%)      2/9 (22.22%)    
Cardiac disorders     
Hypotensive episode [1]  0/11 (0.00%)  0 1/9 (11.11%)  1
Chest pain [2]  0/11 (0.00%)  0 1/9 (11.11%)  1
Skin and subcutaneous tissue disorders     
Skin breakdown [3]  1/11 (9.09%)  1 0/9 (0.00%)  0
Vascular disorders     
Stroke [4]  1/11 (9.09%)  1 0/9 (0.00%)  0
[1]
Sudden drop in blood pressure at subject's home leading to brief hospitalization; adverse event deemed "unrelated" to protocol.
[2]
Sudden chest pain prior to therapy leading to ER visit and brief hospitalization; adverse event deemed "unrelated" to protocol.
[3]
Skin breakdown as a result of therapy; adverse event deemed "definitely related" to protocol.
[4]
Subject with a second stroke during the post-treatment phase of study participation; adverse event deemed "unrelated" to protocol.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lokomat Intervention Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/11 (45.45%)      3/9 (33.33%)    
Skin and subcutaneous tissue disorders     
Minor skin breakdown [1]  5/11 (45.45%)  12 3/9 (33.33%)  3
[1]
minor skin breakdown
Limitations include: small sample (n=21 enrolled, n=20 completed) and significant (p=0.025) difference between groups in time since stroke (Lokomat group, time since stroke mean=1353.60 days; Conventional group, time since stroke mean=525.00 days).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Elizabeth Noser
Organization: Mischer Neuroscience Institute, Memorial Hermann-TMC
Responsible Party: Elizabeth Noser, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00975156     History of Changes
Other Study ID Numbers: HSC-MH-08-0206
Medallion Grant
First Submitted: September 10, 2009
First Posted: September 11, 2009
Results First Submitted: August 14, 2012
Results First Posted: September 13, 2012
Last Update Posted: February 25, 2013