N/A
N=53
Effects of Device-assisted Practice of ADL on Arm/Hand Recovery in Individuals With Moderate to Severe Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT04077073 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Box and Blocks Test (BBT) — 5.7; 8.8 blocks
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ReIn-Hand (Device); Robot (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Box and Blocks Test (BBT) |
5.7; 8.8 | — |
| SECONDARY Upper Extremity Fugl-Meyer Assessment Score |
23.0; 24.3 | — |
| SECONDARY Chedoke McMaster Stroke Assessment (CMSA) Hand Subscale |
3.4; 3.4 | — |
| SECONDARY Action Research Arm Test (ARAT) |
13.8; 17.6 | — |
| SECONDARY Kinaesthesia Subscale of Nottingham Sensory Assessment |
8.42; 9.72 | — |
| SECONDARY Cutaneous Sensory Touch Threshold Using Semmes-Weinstein Monofilaments |
4.51; 4.59; 3.39; 3.57 | — |
| SECONDARY Motor Activity Log (MAL) |
0.84; 0.94; 0.86; 1.02 | — |
| SECONDARY Stroke Impact Scale (SIS) Stroke Recovery Question |
61; 62 | — |
| SECONDARY Stereognosis Subscale of Nottingham Sensory Assessment |
12.1; 14.5 | — |
| SECONDARY Quantitative Measure of Hand Closing Force (QMHC) |
69.86; 77.02; 18.06; 22.61 | — |
| SECONDARY Fractional Anisotropy (FA) of Bilateral Cortico-fugal Tracts |
0.4140; 0.4181; 0.3700; 0.3677 | — |
| SECONDARY Hand Pentagon Area (HPA) While Opening With or Without Lifting |
21.66; 19.42; 19.43; 15.77 | — |
| SECONDARY Global Rating of Change (GROC) |
3.15; 4.25 | — |
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.
Eligibility Criteria
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 =23
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04077073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.