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Extension of the MIME Robotic System for Stroke Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00995774
Recruitment Status : Completed
First Posted : October 15, 2009
Results First Posted : February 14, 2014
Last Update Posted : September 20, 2018
Sponsor:
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: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Stroke
Impaired Upper Extremity Function
Interventions Device: robotic therapy
Other: conventional functional training
Enrollment 12
Recruitment Details Recruitment was through "word of mouth" with therapists at the outpatient clinics of the DC Veterans Affair Medical Center and the MedStar National Rehabilitation Hospital. Recruitment took place approximately between 9/2010 and 3/2012.
Pre-assignment Details Fourteen individuals were recruited. One subject was excluded due to a prior orthopedic injury and another subject did not meet the Folstein Mini–Mental State Examination criterion. Two subjects completed the protocol up through the initial training period and the washout period, but did not return for the second therapy block.
Arm/Group Title Robotic Then Conventional Conventional Then Robotic
Hide Arm/Group Description 12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist 12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
Period Title: Training Period 1
Started 7 5
Completed 7 5
Not Completed 0 0
Period Title: Washout Period
Started 7 5
Completed 7 5
Not Completed 0 0
Period Title: Training Period 2
Started 7 5
Completed 5 5
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             2             0
Arm/Group Title Robotic Then Conventional Conventional Then Robotic Total
Hide Arm/Group Description 12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist 12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy Total of all reporting groups
Overall Number of Baseline Participants 7 5 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  57.1%
4
  80.0%
8
  66.7%
>=65 years
3
  42.9%
1
  20.0%
4
  33.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 5 participants 12 participants
57.7  (10.8) 57.8  (16.3) 57.7  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
Female
3
  42.9%
0
   0.0%
3
  25.0%
Male
4
  57.1%
5
 100.0%
9
  75.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 7 participants 5 participants 12 participants
7
 100.0%
5
 100.0%
12
 100.0%
1.Primary Outcome
Title Fugl-Meyer Test of Motor Function
Hide Description This scale assesses motor impairments at the shoulder, elbow, wrist and fingers (Fugl-Meyer 1975). Individual subscores are added to create a total score that ranges from 0 to 66 points. A score of 66 indicates no impairment.
Time Frame before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robotic Then Conventional Conventional Then Robotic
Hide Arm/Group Description:
12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
Overall Number of Participants Analyzed 7 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from beginning to end of training period 1 1.9  (4.6) .8  (2.9)
Change from beginning to end of washout period 1.3  (4.4) .8  (3.9)
Change from beginning to end of training period 2 1.6  (3.6) 1.6  (2.3)
2.Secondary Outcome
Title Action Research Arm Test
Hide Description This scale is a standardized assessment of functional limitations in the upper extremity. Individual subscores are summed to create a total score that ranges from 0 to 57 points. A score of 57 indicates no functional limitations.
Time Frame before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robotic Then Conventional Conventional Then Robotic
Hide Arm/Group Description:
12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
Overall Number of Participants Analyzed 7 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from beginning to end of training period 1 4.6  (3.5) -.2  (1.1)
Change from beginning to end of washout period .4  (2.9) 0  (1.6)
Change from beginning to end of training period 2 -2  (5.9) 1.4  (3.0)
3.Secondary Outcome
Title A Motion Analysis Evaluation Will be Performed on Reach and Grasp Tasks. The Kinematics Will be Measured Using an Electromagnetic Tracker (Flock of Birds, Ascension Technology Corp., Burlington VT).
Hide Description [Not Specified]
Time Frame pre-treatment, post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Data initially collected but could not interpret results due to a lack of resources and incomplete data analysis. No further staff, tools, or information is available to report conclusions.
Arm/Group Title Robotic Then Conventional Conventional Then Robotic
Hide Arm/Group Description:
12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Robotic Then Conventional Conventional Then Robotic
Hide Arm/Group Description 12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist 12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
All-Cause Mortality
Robotic Then Conventional Conventional Then Robotic
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Robotic Then Conventional Conventional Then Robotic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Robotic Then Conventional Conventional Then Robotic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/5 (0.00%) 
The limited therapy hours could mask potential gains that would have been made with additional therapy. Due to the small sample size, these results need to be confirmed in a larger scale study using a parallel study design.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Peter Lum, PhD
Organization: Washington DC Veterans Affairs Medical Center
Phone: 202-319-5181
EMail: lum@cua.edu
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00995774     History of Changes
Other Study ID Numbers: B4719-R
First Submitted: October 8, 2009
First Posted: October 15, 2009
Results First Submitted: October 31, 2013
Results First Posted: February 14, 2014
Last Update Posted: September 20, 2018