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NCT04077073Completed

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

Effects of Device-assisted Practice of Activities of Daily Living in a Close-to-normal Pattern on Upper Extremity Motor Recovery in Individuals With Moderate to Severe Stroke

Source: ClinicalTrials.gov · Last updated 4 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
53 (actual)
First submitted
28 Aug 2019
Start date
23 Sept 2019
Primary completion date
16 Dec 2024
Lead sponsor
Northwestern University
Diseases
Stroke
NCT number
NCT04077073

What you commit to

  • Study type: Interventional
  • Participants enrolled: 53
  • From 23 Sept 2019 to the primary completion date, 16 Dec 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe concurrent medical problems (e.g. cardiorespiratory impairment, uncontrolled hypertension, inflammatory joint disease)
  • 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
  • Participating in any experimental rehabilitation or drug studies
  • Upper extremity musculoskeletal impairment limiting function prior to stroke
  • Currently using oxygen

Other illness

  • Motor or sensory impairment in the non-affected limb
  • 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)

Other

  • Any brainstem and/or cerebellar lesion
  • 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
  • Inability to attend intervention sessions 3 times a week during 8 weeks, as well as to assessments/evaluations and follow up
  • Upper limb amputation

Who the study is looking for

  • 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

Age in the registry: 21 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
645 N Michigan Ave, Suite 1100
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Northwestern University, Dept. of PTHMS
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.