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| Name | Class |
|---|---|
| New York Presbyterian Hospital | OTHER |
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This is an interventional pilot study investigating the feasibility of using the hand of hope (HOH) device for individuals with decreased hand function after stroke.
The HOH will be used to provide hand training for patients with decreased hand ability after stroke. The HOH is a light-weight, non-invasive, portable hand robot that provides physical assistance when a patient activates the muscles that open and close the hand. The HOH works by detecting surface EMG muscle activity and therefore requires active participation from the patient throughout the session. Video games linked to the HOH device are specifically designed to work on opening and closing the hand facilitating mass practice and high repetition needed for improving strength and range of motion of muscles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| interventional group | Experimental | This is a single group, interventional pilot study. All participants will receive 6-week hand training on the HOH device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand of Hope (HOH) | Device | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment of Upper Extremity (FMA) | 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. | baseline to 6 weeks (discharge) |
| Arm Motor Ability Test (AMAT) | 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. | Baseline to 6 weeks (discharge) |
| Box and Blocks | 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. | Baseline to 6 weeks (discharge) |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Upper Limb Capacity Scale (SULCS) | 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. | Baseline to 6 weeks (discharge) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NewYork Presbyterian Hospital-Weill Cornell Medical Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18928333 | Background | O'Dell MW, Lin CC, Harrison V. Stroke rehabilitation: strategies to enhance motor recovery. Annu Rev Med. 2009;60:55-68. doi: 10.1146/annurev.med.60.042707.104248. | |
| 21097247 | Background | Tong KY, Ho SK, Pang PK, Hu XL, Tam WK, Fung KL, Wei XJ, Chen PN, Chen M. An intention driven hand functions task training robotic system. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:3406-9. doi: 10.1109/IEMBS.2010.5627930. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Interventional Group | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fugl-Meyer Assessment of Upper Extremity (FMA) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline to 6 weeks (discharge) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild skin rubbing | Skin and subcutaneous tissue disorders | Non-systematic Assessment | 7 subjects reported mild skin rubbing/pinching on proximal interphalangeal joint related to changes in fit of the device during training. Symptoms resolved with positional re-adjustment and/or added padding to hand (padding on finger joint or glove) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grace Kim PhD, OTR/L | New York University | 121-998-5846 | gjk207@nyu.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Hand Dynamometry |
A dynamometer measures grip strength in kilograms |
| baseline to 6 weeks (discharge) |
| Stroke Impact Scale --Hand Sub Scale (SIS-H) | 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 | baseline to 6 weeks (discharge) |
| 22275545 | Result | Ho NS, Tong KY, Hu XL, Fung KL, Wei XJ, Rong W, Susanto EA. An EMG-driven exoskeleton hand robotic training device on chronic stroke subjects: task training system for stroke rehabilitation. IEEE Int Conf Rehabil Robot. 2011;2011:5975340. doi: 10.1109/ICORR.2011.5975340. |
| 23932795 | Result | Hu XL, Tong KY, Wei XJ, Rong W, Susanto EA, Ho SK. The effects of post-stroke upper-limb training with an electromyography (EMG)-driven hand robot. J Electromyogr Kinesiol. 2013 Oct;23(5):1065-74. doi: 10.1016/j.jelekin.2013.07.007. Epub 2013 Aug 7. |
| 12907818 | Result | Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Box and Blocks | This is a performance-based assessment of unilateral gross manual dexterity of the upper extremity in adults after stroke. The total score is the number of 2.5cc blocks successfully transferred with the affected hand from one box to another in one minute. | Mean | Standard Deviation | number of blocks |
|
| Arm Motor Ability Test (AMAT) | Performance-based measure to assess ability of participant to perform everyday functional upper extremity tasks unilaterally or bilaterally. Scoring is based on a 0-5 ordinal scale, with 0 being no ability and 5 being normal arm ability (highest score). It is comprised on 10 functional tasks. The total score is the average of scores on individual task items combined. | Mean | Standard Deviation | units on a scale |
|
| Fugl-Meyer Assessment (FMA) | The FMA is a widely-used performance-based measure of impairment for nine upper extremity movements. It examines flexor and extensor synergy patterns, movements out of synergy patterns, wrist and hand movements, as well as strength and coordination of fine motor movements. Scores range from 0-66, with 66 being the highest score possible. For this study, the three reflex items were omitted from the final score because it is considered a separate construct from motor impairment making the maximum score 60. | Mean | Standard Deviation | units on a scale |
|
| Stroke Upper Limb Capacity Scale (SULCS) | The SULCS was developed to measure the capacity of the affected upper limb after stroke. Each of the 10 items arranged in a hierarchical order is assigned a score of 0 (unable to complete) or 1 (able to complete the task) with a maximum score of 10. | Mean | Standard Deviation | units on a scale |
|
| Stroke Impact Scale-Hand Subscale | 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 to a maximum of 5. Only the Hand sub-score (SIS-H) 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 | Mean | Standard Deviation | units on a scale |
|
| Dynamometry | Dynamometer is a valid and reliable assessment of grip strength (impairment) measured in kilograms. | Mean | Standard Deviation | kilograms |
|
|
|
|
| Primary | Arm Motor Ability Test (AMAT) | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 6 weeks (discharge) |
|
|
|
| Primary | Box and Blocks | 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. | Posted | Mean | Standard Deviation | totally number of blocks transferred | Baseline to 6 weeks (discharge) |
|
|
|
| Secondary | Stroke Upper Limb Capacity Scale (SULCS) | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 6 weeks (discharge) |
|
|
|
| Secondary | Hand Dynamometry | A dynamometer measures grip strength in kilograms | Posted | Mean | Standard Deviation | kilograms | baseline to 6 weeks (discharge) |
|
|
|
| Secondary | Stroke Impact Scale --Hand Sub Scale (SIS-H) | 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 | Posted | Mean | Standard Deviation | units on a scale | baseline to 6 weeks (discharge) |
|
|
|
| 0 |
| 12 |
| 7 |
| 12 |
|
| fatigue (cognitive) | General disorders | Non-systematic Assessment | 3 participants experienced feeling tired (attention) toward end of hand training sessions. Short rest breaks used to alleviate symptoms. Did not interfere with participation |
|
| shoulder fatigue | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | 6 subjects reported muscle fatigue at shoulder during training as a results of active use. Did not interfere with study participation |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |