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Device-assisted Practice

Device-Assisted ADL Practice for Stroke Recovery

N/A
Recruiting
Led By Jun Yao, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Intact skin on the hemiparetic arm
Discharged from all forms of physical rehabilitation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this will be measured 1 time pre-intervention (within 1 week prior to intervention), and 1 time immediately after conclusion of intervention (within 1 week).
Awards & highlights

Study Summary

This trial looks at the effects of using a device to help practice activities of daily living for people with moderate to severe stroke. The goal is to improve UE motor recovery by measuring changes in clinical outcomes, UE kinematics, and functional and morphologic neuroplasticity.

Who is the study for?
This trial is for individuals aged 21-80 who have had a moderate to severe stroke, resulting in significant arm weakness but with some ability to move. They must be able to sit for an hour, have a certain level of cognitive function (MoCA score >=23), and not be receiving other physical rehabilitation. Exclusions include recent seizures, severe sensory impairment in the arm, prior injections affecting muscle control, other neurological disorders or serious medical conditions.Check my eligibility
What is being tested?
The study tests whether using a device called ReIn-Hand alongside robot assistance can help improve the use of arms/hands during daily activities after suffering from a stroke. It measures changes in motor skills and brain adaptability post-intervention.See study design
What are the potential side effects?
Potential side effects are not explicitly listed; however, participants may experience discomfort or fatigue due to repetitive movements during therapy sessions with the ReIn-Hand device and robot-assisted exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My skin is healthy on the arm affected by my stroke.
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I have completed all my physical rehabilitation.
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I can open my hand at least 4 cm wide with help from a device and therapist.
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I understand and can agree to the study's procedures and risks.
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I have weakness on one side of my body, affecting my arm but can still move it a little.
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My cognitive function score is 23 or higher.
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I am between 21 and 80 years old.
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I can lift my arm and straighten my elbow somewhat against gravity.
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I can sit for at least 1 hour without discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this will be measured 1 time pre-intervention (within 1 week prior to intervention), and 1 time immediately after conclusion of intervention (within 1 week).
This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be measured 1 time pre-intervention (within 1 week prior to intervention), and 1 time immediately after conclusion of intervention (within 1 week). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Box and Blocks Test (BBT) from baseline to 1 week post-intervention
Secondary outcome measures
Change in Action Research Arm Test (ARAT)
Change in Chedoke McMaster Stroke Assessment (CMSA) Hand Subscale
Change in Cortical activity ratio (CAR)
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ReIn-hand and robotExperimental Treatment2 Interventions
The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand and of robot to reduce the shoulder load.
Group II: ReIn-HandActive Control1 Intervention
The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Robot
2019
N/A
~190

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,580 Previous Clinical Trials
916,787 Total Patients Enrolled
30 Trials studying Stroke
25,145 Patients Enrolled for Stroke
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,956 Previous Clinical Trials
2,672,160 Total Patients Enrolled
79 Trials studying Stroke
5,334 Patients Enrolled for Stroke
Jun Yao, PhDPrincipal Investigator - Northwestern University
Northwestern University
1 Previous Clinical Trials
3 Total Patients Enrolled
1 Trials studying Stroke
3 Patients Enrolled for Stroke

Media Library

ReIn-Hand (Device-assisted Practice) Clinical Trial Eligibility Overview. Trial Name: NCT04077073 — N/A
Stroke Research Study Groups: ReIn-Hand, ReIn-hand and robot
Stroke Clinical Trial 2023: ReIn-Hand Highlights & Side Effects. Trial Name: NCT04077073 — N/A
ReIn-Hand (Device-assisted Practice) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04077073 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What progressions or results do researchers anticipate from this clinical trial?

"This trial will assess the efficacy of a given intervention by gauging changes in Box and Blocks Test (BBT) scores from baseline to post-intervention. Secondary outcomes include alterations in Cortical Activity Ratio (CAR), Motor Activity Log, and Stroke Impact Scale (SIS). Data collection is set to occur twice prior to treatment, once per week during treatment, one more time after conclusion of said treatment, as well as at 3 months follow up."

Answered by AI

Is this research initiative inviting individuals aged 50 and above to participate?

"This trial is seeking participants aged 21 up to 80 years. For individuals that fall outside this age range, there are 38 trials for those under 18 and 1006 studies available for seniors over 65."

Answered by AI

Who is able to register for participation in this trial?

"This medical trial is enrolling 60 individuals aged 21-80 who are currently living with stroke. To be eligible, they must possess the ability to elevate their limb against gravity up to 75 degrees of shoulder flexion and generate active elbow extension; open hand with a thumb-to-index finger distance ≥4 cm when supported by the ReIn-Hand device; exercise sufficient motor control as indicated on UE FMA (10-40/66) and CMSA_H stage of the hand section ≤ 4 scales; have no need for physical rehabilitation or therapy post discharge; display intact skin on affected arm area; tolerate sitting for 1 hour minimum"

Answered by AI

What is the limit of participants currently authorized for this research?

"Affirmative. Clinicaltrials.gov reveals that recruitment for this trial commenced on September 23rd 2019 and was last updated April 12th 2022, with 60 individuals required to participate across 2 sites."

Answered by AI

Could potential participants still join this experiment?

"This clinical trial is presently welcoming enrollees, with the initial posting having been made on September 23rd 2019 and the most recent revision taking place on April 12th 2022 (as indicated by information provided at clinicaltrials.gov)."

Answered by AI
~5 spots leftby Sep 2024