MyHand: An Active Hand Orthosis for Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Score on Action Research Arm Test (ARAT)
Study Overview
Brief Summary
This study seeks to explore the efficacy of several control mechanisms for the device and the impact of a device training program on its utility as a neuroprosthetic and training tool for upper limb recovery.
Detailed Description
Hand rehabilitation through occupational therapy is critical for many stroke survivors, but it is also greatly limited by insurance coverage, shortage of therapists, and logistic constraints. To address this, stroke patients need a rehabilitation method they can use on their own, without direct clinical supervision, and for activities of daily living. MyHand is a wearable and active hand orthosis consisting of a glove and forearm splint, equipped with actuators and tendons which connect to the fingers.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Subjects are assessed by an independent therapist. The therapist is not blinded to the control mechanism used during treatment.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects over 18 years of age
- •History of stroke resulting in significant upper limb impairment
- •Full passive range of motion
- •Gross control of the proximal upper extremity
- •Lacks timely grasp/release
- •No more than moderate flexor tone
- •Intact cognition
- •Exclusion criteria include:
- •Other Neurological/orthopedic disorders
- •Excessive spasticity/contracture
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Score on Action Research Arm Test (ARAT)
Time Frame: Baseline; Post-test at Week 4
The ARAT is a 19-item measure that assesses upper limb functioning. The ARAT is divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from 0 (cannot perform) to 3 (normal performance). Scores on the ARAT range from 0-57 points, with higher scores indicating better performance.
Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM)
Time Frame: Baseline; Post-test at Week 4
The Fugl-Meyer (FM) Assessment of Motor Recovery evaluates and measures recovery in post-stroke hemiplegic patients. The FM uses a 3-point ordinal scale from 0 (cannot perform) to 2 (performs fully). The FM has 5 domains with a maximum score of 226 points. Subscales can be administered with out using the full FM. The Upper Extremity component (UEFM) consists of 33 items with a score range of 0-66. Higher score indicate better performance. Please note: An a prior decision was made to only perform the UEFM once at post-testing: post test without robotic assistance. The UEFM assesses capacity of the arm primarily through gross motor tasks, and comparatively few grasping and pinching tasks. Thus, it was presumed that robotic assistance would have minimal influence on UEFM scores. In other words, the UEFM was intended as a outcome measure to primarily evaluate the rehabilitative effects of training with the device, as opposed to evaluating the assistive capacity of using the device.
Secondary Outcomes
- Score on Modified Ashworth Scale (MAS)(Baseline)
- Score on Box and Blocks Test (BBT)(Baseline; Post-test at Week 4)
- Number of Participants Completing Treatment Protocol(4 Weeks)
- Total Number of Adverse Events During Intervention(4 Weeks)
Investigators
Joel Stein, MD
Simon Baruch Professor of Physical Medicine and Rehabilitation
Columbia University