New device helps stroke patients relearn daily tasks
NCT ID NCT04077073
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a device that assists hand opening and a robot that supports the shoulder can help stroke survivors with moderate to severe arm weakness practice daily activities. 53 participants completed the trial. The goal was to see if this device-assisted practice improves arm movement, dexterity, and brain recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ReIn-Hand device and robot support
- What this could lead to
- If successful, this approach could lead to better rehabilitation methods for stroke survivors with moderate to severe arm weakness.
- What could go wrong
- This is a small, completed trial without a control group, so results may not apply to everyone. The devices may not work for all types of stroke impairment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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53 people
The number who actually took part.
- Started
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Sep 2019
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age between 21-80 2. 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) 3. Capacity to provide informed consent 4. Ability to elevate their limb against gravity up to at least 75 degrees of shoulder flexion and to generate some active elbow extension 5. 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 6. MRI compatible 7. Discharged from all forms of physical rehabilitation 8. Intact skin on the hemiparetic arm 9. Be tolerate sitting for no less than 1 hour 10. Montreal Cognitive Assessment (MoCA) score \>=23 Exclusion Criteria: 1. Motor or sensory impairment in the non-affected limb 2. Any brainstem and/or cerebellar lesion 3. Severe concurrent medical problems (e.g. cardiorespiratory impairment, uncontrolled hypertension, inflammatory joint disease) 4. 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) 5. Any acute or chronic painful condition in the upper extremities or spine, indicated by a score ≥5 on a 10-point visual analog scale 6. Using cardiac pacemaker, implanted cardioverter defibrillator, neurostimulation system inside the brain or spinal cord, bone growth box fusion stimulation 7. Seizure in the last 6 months 8. 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) 9. 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 10. Unable to passively attain 90 degrees of shoulder flexion and abduction, measured using a goniometer based on adapted methods 11. Flexion contractures larger than 45 degrees in the elbow, wrist, metacarpophalangeal joints (MCP) and interphalangeal joints (IP) of thumb and index finger 12. Pregnant or planning to become pregnant 13. Participating in any experimental rehabilitation or drug studies 14. Inability to attend intervention sessions 3 times a week during 8 weeks, as well as to assessments/evaluations and follow up 15. Upper extremity musculoskeletal impairment limiting function prior to stroke 16. Currently using oxygen 17. Upper limb amputation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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645 N Michigan Ave, Suite 1100
Chicago, Illinois, 60611, United States
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Northwestern University, Dept. of PTHMS
Chicago, Illinois, 60611, United States
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Other studies related to the condition(s) this trial covers.
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