Stroke
Conditions
Keywords
stroke, robotics, hand rehabilitation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHand 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: * warm up-passive stretch of hand in flexion and extension (5 minutes); * setting the EMG threshold parameters for the device; * active practicing of opening the hand (Desperate Bee, Hungry Bird, Sun Archer games; 10 min) * active practice of closing then hand (UFO Catcher game; 10 min) * open and closing the hand (Ball and Basket game; 10 min) * open and closing the hand while incorporating reach ( for subjects with adequate ability to reach with shoulder/elbow; 10 min) * cool down-passive stretch of hand in flexion and extension (5 minutes)
Sponsors
New York Presbyterian Hospital
Rehab-Robotics Company Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of stroke \> 6 months ago 2. Presence of some active range of motion (AROM) in the affected hand, measured by a score of at least 1 on the Box and Block test. 3. Intact sensation in the affected hand 4. Full passive range of motion (PROM) in mass flexion and extension of the hand 5. MAS score \< 3 for finger flexors and intrinsics 6. MAS score \< 3 for finger extensors 7. Visual tracking is intact in all directions 8. Patient must be otherwise medically stable in the opinion of the principal investigator
Exclusion criteria
1. Patient is receiving active occupational or physical therapy for the affected arm 2. Patient has joint contractures that prevent proper fit into the HOH device 3. Patient has other concurrent neurological or orthopedic diagnoses that affect motor ability of the arm such as Parkinson's or Multiple Sclerosis, or arthritis 4. It has been less than 3 months since last botulinum toxin injection in the affected arm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment of Upper Extremity (FMA) | 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) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Upper Limb Capacity Scale (SULCS) | 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 | baseline to 6 weeks (discharge) | A dynamometer measures grip strength in kilograms |
| Stroke Impact Scale --Hand Sub Scale (SIS-H) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Interventional Group |
|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 10.2 |
| Arm Motor Ability Test (AMAT) | 2.13 units on a scale STANDARD_DEVIATION 0.5 |
| Box and Blocks | 5.67 number of blocks STANDARD_DEVIATION 10.36 |
| Dynamometry | 7.96 kilograms STANDARD_DEVIATION 6.24 |
| Fugl-Meyer Assessment (FMA) | 20.75 units on a scale STANDARD_DEVIATION 7.9 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 2 Participants |
| Stroke Impact Scale-Hand Subscale | 11.50 units on a scale STANDARD_DEVIATION 4.91 |
| Stroke Upper Limb Capacity Scale (SULCS) | 5.33 units on a scale STANDARD_DEVIATION 2.15 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: Baseline to 6 weeks (discharge)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Group | Arm Motor Ability Test (AMAT) | 2.35 units on a scale | Standard Deviation 0.58 |
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.
Time frame: Baseline to 6 weeks (discharge)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Group | Box and Blocks | 6.08 totally number of blocks transferred | Standard Deviation 10 |
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.
Time frame: baseline to 6 weeks (discharge)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Group | Fugl-Meyer Assessment of Upper Extremity (FMA) | 22.50 units on a scale | Standard Deviation 9.47 |
p-value: <0.05Friedman Test
Secondary
Hand Dynamometry
A dynamometer measures grip strength in kilograms
Time frame: baseline to 6 weeks (discharge)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Group | Hand Dynamometry | 8.23 kilograms | Standard Deviation 6.18 |
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
Time frame: baseline to 6 weeks (discharge)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Group | Stroke Impact Scale --Hand Sub Scale (SIS-H) | 13.33 units on a scale | Standard Deviation 5.48 |
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.
Time frame: Baseline to 6 weeks (discharge)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Group | Stroke Upper Limb Capacity Scale (SULCS) | 5.17 units on a scale | Standard Deviation 2.17 |