Effects of Device-assisted Practice of ADL on Arm/Hand Recovery in Individuals With Moderate to Severe Stroke

Completed · Not applicable

Conditions studied: Stroke

In brief

A large number of post-stroke survivors cannot functionally use their paretic upper extremity (UE). This study therefore investigates effects of device-assisted practice of activities of daily living (ADL) in a close-to-normal pattern on UE motor recovery in individuals with moderate to severe stroke by measuring intervention-induced changes in clinical outcomes, UE kinematics, and functional and morphologic neuroplasticity. Positive findings may impact current clinical practice by pushing towards implementing device-assisted practice of ADLs and have the potential to benefit a large population.

Key facts

Study ID: NCT04077073
Run by: Northwestern University
People needed: 53
Starts: 2019-09-23
Expected to finish: 2024-12-16
Last updated by the study team: 2026-05-04

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age between 21-80
Paresis confined to one side, with substantial motor impairment of the upper limb and some residual voluntary movement (Upper Extremity Fugl-Meyer Assessment score in the range of 10-40/66, Chedoke McMaster Stroke Assessment - Stage of the hand section score <=4)
Capacity to provide informed consent
Ability to elevate their limb against gravity up to at least 75 degrees of shoulder flexion and to generate some active elbow extension
Ability to open hand with a thumb-to-index finger distance ≥4 cm, with the assistance of the ReIn-Hand device with the help of a physical therapist
MRI compatible
Discharged from all forms of physical rehabilitation
Intact skin on the hemiparetic arm
Be tolerate sitting for no less than 1 hour
Montreal Cognitive Assessment (MoCA) score >=23

You may not qualify if…

Motor or sensory impairment in the non-affected limb
Any brainstem and/or cerebellar lesion
Severe concurrent medical problems (e.g. cardiorespiratory impairment, uncontrolled hypertension, inflammatory joint disease)
History of neurologic disorder other than stroke (Parkinson's Disease, Acute Lateral Sclerosis, Multiple Sclerosis, Traumatic Brain Injury, peripheral neuropathy, Amyotrophic lateral sclerosis, spinal cord injury, Dementia)
Any acute or chronic painful condition in the upper extremities or spine, indicated by a score ≥5 on a 10-point visual analog scale
Using cardiac pacemaker, implanted cardioverter defibrillator, neurostimulation system inside the brain or spinal cord, bone growth box fusion stimulation
Seizure in the last 6 months
Severe upper extremity sensory impairment indicated by absent sensation on the tactile sensation subscale (light touch and pressure items) of the Revised Nottingham Assessment of Somato-Sensations (score<4)
Chemo denervation: botulinum toxin, dysport, or Myobloc or phenol block injection to any portion of the paretic UE within the last 6 months, or phenol/alcohol injections <12 months before participation
Unable to passively attain 90 degrees of shoulder flexion and abduction, measured using a goniometer based on adapted methods
Flexion contractures larger than 45 degrees in the elbow, wrist, metacarpophalangeal joints (MCP) and interphalangeal joints (IP) of thumb and index finger
Pregnant or planning to become pregnant
Participating in any experimental rehabilitation or drug studies
Inability to attend intervention sessions 3 times a week during 8 weeks, as well as to assessments/evaluations and follow up
Upper extremity musculoskeletal impairment limiting function prior to stroke
Currently using oxygen
Upper limb amputation

Where it is running

645 N Michigan Ave, Suite 1100 — Chicago, Illinois, United States
Northwestern University, Dept. of PTHMS — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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