The purpose of this study is to assess the safety, reliability, and efficacy of the use of the Harmony Scapulohumeral Rhythm (SHR) upper extremity robotic rehabilitation system for persons with impaired functional use of one or both upper extremities due to stroke.
Once recruited, subjects will be randomly assigned to traditional or intervention groups. Subjects in the traditional therapy group will receive up to 24 sessions of traditional occupational therapy intervention focusing on upper limb task training. Subjects in the intervention group will receive up to 24 sessions of functional task training using the Harmony SHR device. These sessions will be conducted by a trained researcher or licensed occupational therapist. Outcome measures will be assessed prior to the first intervention session and following the last intervention session, prior to discharge from inpatient rehabilitation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Functional task training with use of Harmony SHR device
Functional task training of affected limb
Shirley Ryan AbilityLab
Chicago, Illinois, United States
Upper Extremity Fugl-Meyer Assessment (UE FMA)
The Upper Extremity Fugl-Meyer Assessment (UE FMA) is a 33 item stroke-specific, performance-based impairment index designed to assess motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. For the purposes of this study, only the upper extremity motor functioning domain will be assessed. This domain is comprised of assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. Scoring is based on direct observation of performance and items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0 = cannot perform, 1 = performs partially, and 2 = performs fully. Total score range is from 0 to 66, with a higher total score indicates less impairment of the UE being tested.
Time frame: Prior to intervention start, day 1, and prior to discharge from inpatient rehabilitation (on average day 21) and the change in score will be recorded.
Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) is a 19 item observational measure used to assess upper extremity performance (coordination, dexterity, and functioning) in stroke recovery, brain injury, and multiple sclerosis. Items comprising the ARAT are categorized into 4 subscales (grasp, grip, pinch, gross motor) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Score ranges from 0-57. Higher total score indicates more function of the UE being tested.
Time frame: Prior to intervention start, day 1, and prior to discharge from inpatient rehabilitation (on average day 21) and the change in score will be recorded
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