Effects of Device-assisted Practice of ADL on Arm/Hand Recovery in Individuals With Moderate to S… (NCT04077073) | Clinical Trial Compass
CompletedNot Applicable
Effects of Device-assisted Practice of ADL on Arm/Hand Recovery in Individuals With Moderate to Severe Stroke
United States53 participantsStarted 2019-09-23
Plain-language summary
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.
Who can participate
Age range21 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. Motor or sensory impairment in the non-affected limb
What they're measuring
1
Box and Blocks Test (BBT)
Timeframe: Within 1 week after conclusion of intervention
✕. 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)