Trial Outcomes & Findings for Rehabilitation of the Stroke Hand at Home (NCT NCT01144715)
NCT ID: NCT01144715
Last Updated: 2014-11-27
Results Overview
The amount of recovery of arm-hand function is measured with the Action Research Arm Test (ARAT). The ARAT assesses activity limitations of the upper extremity. It includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Scores range from 0-to-57 with a higher score indicating a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
99 participants
Primary outcome timeframe
End of treatment at 8 weeks post enrolment
Results posted on
2014-11-27
Participant Flow
Participant milestones
| Measure |
Hand Mentor Therapy
Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance.
|
Control
Self administered home therapy program
Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
48
|
|
Overall Study
COMPLETED
|
47
|
45
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Hand Mentor Therapy
Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance.
|
Control
Self administered home therapy program
Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Rehabilitation of the Stroke Hand at Home
Baseline characteristics by cohort
| Measure |
Hand Mentor Therapy
n=51 Participants
Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance.
|
Control
n=48 Participants
Self administered home therapy program
Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
59.1 years
STANDARD_DEVIATION 14.1 • n=7 Participants
|
57.5 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
48 participants
n=7 Participants
|
99 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of treatment at 8 weeks post enrolmentThe amount of recovery of arm-hand function is measured with the Action Research Arm Test (ARAT). The ARAT assesses activity limitations of the upper extremity. It includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Scores range from 0-to-57 with a higher score indicating a better outcome.
Outcome measures
| Measure |
Hand Mentor Therapy
n=51 Participants
Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance.
|
Control
n=48 Participants
Self administered home therapy program
Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program
|
|---|---|---|
|
Action Research Arm Test (ARAT)
|
39.47 units on a scale
Standard Deviation 19.83
|
39.89 units on a scale
Standard Deviation 17.13
|
SECONDARY outcome
Timeframe: End of treatment at 8 weeks post enrolmentThe Wolf Motor Function Test (WMFT) is used to measure the degree of function using timed tasks. The WMFT is a 17-item measure used to assess activity limitations of the upper extremity. It is comprised of 2 strength items and 15 timed task performance items. The task performance items begin with the measurement of simple proximal movements and progress to more complex distal and whole limb movements. The WMFT yields two scores: 1) a functional ability score quantifying quality of performance, and 2) a timed score quantifying speed of performance in seconds. A shorter time is better outcome.
Outcome measures
| Measure |
Hand Mentor Therapy
n=51 Participants
Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance.
|
Control
n=48 Participants
Self administered home therapy program
Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program
|
|---|---|---|
|
Wolf Motor Function Test
|
8.67 Seconds
Standard Deviation 4.76
|
7.92 Seconds
Standard Deviation 3.97
|
SECONDARY outcome
Timeframe: End of Treatment at 8 weeks post enrolmentUpper Extremity neurological impairment will be measured using the Fugl-Meyer Upper Extremity Test (FMA). The FMA is an impairment-based measure consisting of 33 movements with higher scores indicating increased ability of the patient to move out of synergistic patterns toward more isolated movements. Movement quality of the affected UE is compared to the non-affected UE on 0-2 ordinal scale with 0 indicating no movement at all, 1 indicating partial movement of the affected extremity, and 2 indicating movement equivalent to the non-affected UEs. The score ranges from 0-to-66.
Outcome measures
| Measure |
Hand Mentor Therapy
n=51 Participants
Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance.
|
Control
n=48 Participants
Self administered home therapy program
Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program
|
|---|---|---|
|
Fugl-Meyer Upper Extremity Test
|
43.43 units on a scale
Standard Deviation 15.64
|
42.89 units on a scale
Standard Deviation 14.58
|
SECONDARY outcome
Timeframe: End of treatment at 8 weeks post enrolmentQuality of Life changes are measured with the Stroke Impact Scale questionnaire. The SIS is a self-rated QOL questionnaire that addresses several domains following stroke: physical strength, memory, feelings and emotions, communication, activities of daily living (ADL), mobility, hand use, meaningful activities, and overall percentage recovery from the stroke. We report the Hand Function subscale, which ranges from 0-to-100. A higher score reflects better hand function.
Outcome measures
| Measure |
Hand Mentor Therapy
n=51 Participants
Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance.
|
Control
n=48 Participants
Self administered home therapy program
Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program
|
|---|---|---|
|
Stroke Impact Scale (SIS)
|
49.4 units on a scale
Standard Deviation 33.5
|
57.6 units on a scale
Standard Deviation 28.2
|
Adverse Events
Hand Mentor Therapy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hand Mentor Therapy
n=51 participants at risk
Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance.
|
Control
n=48 participants at risk
Self administered home therapy program
Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program
|
|---|---|---|
|
General disorders
Lost balance and fell
|
5.9%
3/51 • Number of events 3
|
10.4%
5/48 • Number of events 5
|
|
Gastrointestinal disorders
Ulcer
|
2.0%
1/51 • Number of events 1
|
0.00%
0/48
|
|
Vascular disorders
Recurrent stroke
|
2.0%
1/51 • Number of events 1
|
0.00%
0/48
|
|
Psychiatric disorders
Depression
|
2.0%
1/51 • Number of events 1
|
0.00%
0/48
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60