Status:
COMPLETED
Effects of Device-assisted Practice of ADL on Arm/Hand Recovery in Individuals With Moderate to Severe Stroke
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Stroke
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief 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 ...
Detailed Description
Thirty subjects for each group will be recruited. A REDCap database for this study will be setup to manage every step involved in the protocol. All the potential subjects will go through standardized ...
Eligibility Criteria
Inclusion
- Age between 21-80
- Paresis confined to one side, with substantial motor impairment of the upper limb and some residual voluntary movement (UE FMA in the range of 10-40/66, CMSA\_H stage of the hand section \<=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
Exclusion
- 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
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2024
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04077073
Start Date
September 23 2019
End Date
December 16 2024
Last Update
February 17 2025
Active Locations (2)
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1
645 N Michigan Ave, Suite 1100
Chicago, Illinois, United States, 60611
2
Northwestern University, Dept. of PTHMS
Chicago, Illinois, United States, 60611