Trial Outcomes & Findings for Extension of the MIME Robotic System for Stroke Rehabilitation (NCT NCT00995774)
NCT ID: NCT00995774
Last Updated: 2018-09-20
Results Overview
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.
COMPLETED
PHASE2
12 participants
before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2
2018-09-20
Participant Flow
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.
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.
Participant milestones
| Measure |
Robotic Then Conventional
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
|
Conventional Then Robotic
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
|
|---|---|---|
|
Training Period 1
STARTED
|
7
|
5
|
|
Training Period 1
COMPLETED
|
7
|
5
|
|
Training Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period
STARTED
|
7
|
5
|
|
Washout Period
COMPLETED
|
7
|
5
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
|
Training Period 2
STARTED
|
7
|
5
|
|
Training Period 2
COMPLETED
|
5
|
5
|
|
Training Period 2
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Robotic Then Conventional
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
|
Conventional Then Robotic
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
|
|---|---|---|
|
Training Period 2
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Extension of the MIME Robotic System for Stroke Rehabilitation
Baseline characteristics by cohort
| Measure |
Robotic Then Conventional
n=7 Participants
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
|
Conventional Then Robotic
n=5 Participants
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
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
57.8 years
STANDARD_DEVIATION 16.3 • n=107 Participants
|
57.7 years
STANDARD_DEVIATION 12.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2This 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.
Outcome measures
| Measure |
Robotic Then Conventional
n=7 Participants
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
|
Conventional Then Robotic
n=5 Participants
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
|
|---|---|---|
|
Fugl-Meyer Test of Motor Function
Change from beginning to end of training period 1
|
1.9 units on a scale
Standard Deviation 4.6
|
.8 units on a scale
Standard Deviation 2.9
|
|
Fugl-Meyer Test of Motor Function
Change from beginning to end of washout period
|
1.3 units on a scale
Standard Deviation 4.4
|
.8 units on a scale
Standard Deviation 3.9
|
|
Fugl-Meyer Test of Motor Function
Change from beginning to end of training period 2
|
1.6 units on a scale
Standard Deviation 3.6
|
1.6 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2This 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.
Outcome measures
| Measure |
Robotic Then Conventional
n=7 Participants
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
|
Conventional Then Robotic
n=5 Participants
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
|
|---|---|---|
|
Action Research Arm Test
Change from beginning to end of training period 1
|
4.6 units on a scale
Standard Deviation 3.5
|
-.2 units on a scale
Standard Deviation 1.1
|
|
Action Research Arm Test
Change from beginning to end of washout period
|
.4 units on a scale
Standard Deviation 2.9
|
0 units on a scale
Standard Deviation 1.6
|
|
Action Research Arm Test
Change from beginning to end of training period 2
|
-2 units on a scale
Standard Deviation 5.9
|
1.4 units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: pre-treatment, post treatmentPopulation: 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.
Outcome measures
Outcome data not reported
Adverse Events
Robotic Then Conventional
Conventional Then Robotic
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Peter Lum, PhD
Washington DC Veterans Affairs Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place