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Portable EMG-triggered Hand Robot for Individuals After Stroke

Not Applicable
Completed
Conditions
Stroke
Interventions
Device: Hand of Hope (HOH)
Registration Number
NCT02364700
Lead Sponsor
Rehab-Robotics Company Limited
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
interventional groupHand of Hope (HOH)This is a single group, interventional pilot study. All participants will receive 6-week hand training on the HOH device.
Primary Outcome Measures
NameTimeMethod
Box and BlocksBaseline 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.

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.

Secondary Outcome Measures
NameTimeMethod
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

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 Dynamometrybaseline to 6 weeks (discharge)

A dynamometer measures grip strength in kilograms

Trial Locations

Locations (1)

NewYork Presbyterian Hospital-Weill Cornell Medical Center

🇺🇸

New York, New York, United States

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