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Procedure

Robotic Rehabilitation for Stroke (Aim2&3 Trial)

N/A

Recruiting

Led By Li-Qun Zhang, Ph.D.

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

First focal unilateral lesion, ischemic or hemorrhagic

Rated between stages 2-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm and Hand

Must not have

Severe pain in the shoulder by a self-rating of 7 out of 10 or greater

Severe contracture in the upper extremity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether specific treatments for different types of arm and hand impairments caused by stroke can improve movement.

Who is the study for?

This trial is for individuals who had their first stroke 1-12 months ago, can sit for 3 hours, and have an arm and hand recovery stage rated between 2-4. It's not suitable for those with severe pain or contracture in the upper extremity, apraxia, low mental status scores, recent Botox in the arm, or involvement in other gait/limb studies.

What is being tested?

The study aims to assess and treat complex motor impairments of the arm and hand post-stroke. It will compare effects of different treatments: passive movement using a Hand robot or IntelliArm device versus passive stretching exercises on limb function recovery.

What are the potential side effects?

Potential side effects may include discomfort from stretching or using rehabilitation devices. Overexertion could lead to muscle soreness or fatigue. The equipment used should be safe but might cause minor skin irritation where it contacts the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had one stroke, either from a clot or bleed.

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My arm and hand recovery after stroke is rated between stages 2 to 4.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I rate my shoulder pain as 7 or more out of 10.

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I have severe stiffness in my arm that limits movement.

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I cannot sit in a chair for 3 hours straight.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes from baseline Graded Wolf Motor Function Test (WMFT) at two time points

Secondary study objectives

Changes from baseline Action Research Arm Test (ARAT) at two time points

Changes from baseline Chedoke McMaster Stroke Assessment: Impairment Inventory of Arm and Hand at two time points

Changes from baseline Fugl-Meyer Upper Extremity at two time points

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: The hand robot with passive stretchingExperimental Treatment2 Interventions

Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the hand robot.

Group II: The hand robot with passive movementExperimental Treatment2 Interventions

Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the hand robot for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the hand robot.

Group III: IntelliArm with passive stretchingExperimental Treatment2 Interventions

Group IV: IntelliArm with passive movementExperimental Treatment2 Interventions

Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the IntelliArm for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.

0 / 5Eligibility criteria met