Portable EMG-triggered Hand Robot for Individuals After Stroke
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|ClinicalTrials.gov Identifier: NCT02364700|
Recruitment Status : Completed
First Posted : February 18, 2015
Results First Posted : July 12, 2017
Last Update Posted : July 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Hand of Hope (HOH)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hand Training Utilizing an Electromyography-triggered Hand Robot for Individuals After Chronic Stroke|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: interventional group
This is a single group, interventional pilot study. All participants will receive 6-week hand training on the HOH device.
Device: Hand of Hope (HOH)
Subjects will receive arm training 3x/week for 6 weeks, each session is anticipated to last approximately 60 minutes. Sessions will be scheduled for Monday, Wednesday, and Friday whenever possible to provide a rest period between sessions. Each session will consist of the following:
- Fugl-Meyer Assessment of Upper Extremity (FMA) [ Time Frame: 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.
- Arm Motor Ability Test (AMAT) [ Time Frame: 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.
- Box and Blocks [ Time Frame: 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.
- Stroke Upper Limb Capacity Scale (SULCS) [ Time Frame: 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.
- Hand Dynamometry [ Time Frame: baseline to 6 weeks (discharge) ]A dynamometer measures grip strength in kilograms
- Stroke Impact Scale --Hand Sub Scale (SIS-H) [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364700
|United States, New York|
|NewYork Presbyterian Hospital-Weill Cornell Medical Center|
|New York, New York, United States, 10065|