Trial Outcomes & Findings for Portable EMG-triggered Hand Robot for Individuals After Stroke (NCT NCT02364700)
NCT ID: NCT02364700
Last Updated: 2017-07-12
Results Overview
The FMA is a performance based evaluation of upper limb impairment of the affected arm after stroke. Scoring is based on an ordinal scale of 0 (no movement) to 2 (normal movement). Scoring is based on sum of 30 items, ranging from 0-60.
COMPLETED
NA
12 participants
baseline to 6 weeks (discharge)
2017-07-12
Participant Flow
Participant milestones
| Measure |
Interventional Group
This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.
Subjects will receive arm training 3x/week for 6 weeks
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|---|---|
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Portable EMG-triggered Hand Robot for Individuals After Stroke
Baseline characteristics by cohort
| Measure |
Interventional Group
n=12 Participants
This is a single group, interventional pilot study. All participants will receive 6-week hand training on the HOH device. Subjects will receive arm training 3x/week for 6 weeks.
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|---|---|
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Age, Continuous
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57.1 years
STANDARD_DEVIATION 10.2 • n=5 Participants
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
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Box and Blocks
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5.67 number of blocks
STANDARD_DEVIATION 10.36 • n=5 Participants
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Arm Motor Ability Test (AMAT)
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2.13 units on a scale
STANDARD_DEVIATION .50 • n=5 Participants
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Fugl-Meyer Assessment (FMA)
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20.75 units on a scale
STANDARD_DEVIATION 7.90 • n=5 Participants
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Stroke Upper Limb Capacity Scale (SULCS)
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5.33 units on a scale
STANDARD_DEVIATION 2.15 • n=5 Participants
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Stroke Impact Scale-Hand Subscale
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11.50 units on a scale
STANDARD_DEVIATION 4.91 • n=5 Participants
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Dynamometry
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7.96 kilograms
STANDARD_DEVIATION 6.24 • n=5 Participants
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PRIMARY outcome
Timeframe: baseline to 6 weeks (discharge)The FMA is a performance based evaluation of upper limb impairment of the affected arm after stroke. Scoring is based on an ordinal scale of 0 (no movement) to 2 (normal movement). Scoring is based on sum of 30 items, ranging from 0-60.
Outcome measures
| Measure |
Interventional Group
n=12 Participants
This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.
Subjects will receive arm training 3x/week for 6 weeks
|
|---|---|
|
Fugl-Meyer Assessment of Upper Extremity (FMA)
|
22.50 units on a scale
Standard Deviation 9.47
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PRIMARY outcome
Timeframe: Baseline to 6 weeks (discharge)The AMAT is performance based measure of functional ability of the affected arm and hand in unilateral and bilateral everyday tasks. It is comprised of 10 functional tasks such as cutting meat with a knife and fork, donning a t-shirt, and phone use with a score ranging from 0 to a maximum of 5 for each item. The total score is the mean score for all individual item scores.
Outcome measures
| Measure |
Interventional Group
n=12 Participants
This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.
Subjects will receive arm training 3x/week for 6 weeks
|
|---|---|
|
Arm Motor Ability Test (AMAT)
|
2.35 units on a scale
Standard Deviation 0.58
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PRIMARY outcome
Timeframe: Baseline to 6 weeks (discharge)The Box and Blocks is a performance-based functional assessment of hand dexterity ( gross grasp and release). The total score is the number of 2.5cc blocks successfully transferred from one box to another with the affected hand in one minute.
Outcome measures
| Measure |
Interventional Group
n=12 Participants
This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.
Subjects will receive arm training 3x/week for 6 weeks
|
|---|---|
|
Box and Blocks
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6.08 totally number of blocks transferred
Standard Deviation 10
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SECONDARY outcome
Timeframe: Baseline to 6 weeks (discharge)The SULCs is a performance based measure of upper limb capacity after stroke. Each of the 10 items are administered in a hierarchical order and assigned a score of 0 (unable to complete) or 1 (able to complete the task) with a maximum score of 10.
Outcome measures
| Measure |
Interventional Group
n=12 Participants
This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.
Subjects will receive arm training 3x/week for 6 weeks
|
|---|---|
|
Stroke Upper Limb Capacity Scale (SULCS)
|
5.17 units on a scale
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: baseline to 6 weeks (discharge)A dynamometer measures grip strength in kilograms
Outcome measures
| Measure |
Interventional Group
n=12 Participants
This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.
Subjects will receive arm training 3x/week for 6 weeks
|
|---|---|
|
Hand Dynamometry
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8.23 kilograms
Standard Deviation 6.18
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SECONDARY outcome
Timeframe: baseline to 6 weeks (discharge)The Stroke Impact Scale is a stroke-specific questionnaire evaluating quality of life in stroke survivors over eight domains. Each domain is scored independently on an ordinal scale ranging from 0 (minimum) bto a maximum of 5. Only the Hand sub-score was used in this study. Scores for each domain are transformed and range from 0-100. Formula for scoring domains: Transformed Scale = \[(Actual raw score - lowest possible raw score) / Possible raw score\] \* 100
Outcome measures
| Measure |
Interventional Group
n=12 Participants
This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.
Subjects will receive arm training 3x/week for 6 weeks
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|---|---|
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Stroke Impact Scale --Hand Sub Scale (SIS-H)
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13.33 units on a scale
Standard Deviation 5.48
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Adverse Events
Interventional Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Interventional Group
n=12 participants at risk
This is a single group, interventional pilot study. Participants will received 6-week hand training on the HOH device.
Subjects will receive arm training 3x/week for 6 weeks
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|---|---|
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Skin and subcutaneous tissue disorders
mild skin rubbing
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58.3%
7/12 • Number of events 7
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General disorders
fatigue (cognitive)
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25.0%
3/12 • Number of events 3
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Musculoskeletal and connective tissue disorders
shoulder fatigue
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50.0%
6/12 • Number of events 6
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place