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Clinical Trials/NCT02364700
NCT02364700
Completed
Not Applicable

Hand Training Utilizing an Electromyography-triggered Hand Robot for Individuals After Chronic Stroke

Rehab-Robotics Company Limited1 site in 1 country12 target enrollmentMarch 2015
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Rehab-Robotics Company Limited
Enrollment
12
Locations
1
Primary Endpoint
Box and Blocks
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
June 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of stroke \> 6 months ago
  • 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.
  • Intact sensation in the affected hand
  • Full passive range of motion (PROM) in mass flexion and extension of the hand
  • MAS score \< 3 for finger flexors and intrinsics
  • MAS score \< 3 for finger extensors
  • Visual tracking is intact in all directions
  • Patient must be otherwise medically stable in the opinion of the principal investigator

Exclusion Criteria

  • Patient is receiving active occupational or physical therapy for the affected arm
  • Patient has joint contractures that prevent proper fit into the HOH device
  • Patient has other concurrent neurological or orthopedic diagnoses that affect motor ability of the arm such as Parkinson's or Multiple Sclerosis, or arthritis
  • It has been less than 3 months since last botulinum toxin injection in the affected arm

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Stroke Impact Scale --Hand Sub Scale (SIS-H)(baseline to 6 weeks (discharge))
  • Stroke Upper Limb Capacity Scale (SULCS)(Baseline to 6 weeks (discharge))
  • Hand Dynamometry(baseline to 6 weeks (discharge))

Study Sites (1)

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