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Supported Reaching + Abduction Loading for Stroke (PRALINE Trial)

N/A
Recruiting
Led By Michael D Ellis, PT, DPT
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hemiparesis confined to one side, (CMSA Stage 2 or 3 out of 7)
Ability to perform a 3-step motor command with the unaffected arm
Must not have
Premorbid and persistent disability or motor impairment of the upper extremities
Brainstem and/or cerebellar lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in stroke impact scale will be modeled from baseline, weekly (until discharge from rehabilitation, on average 4 to 10 weeks), and monthly evaluations (every-other month until 12 months post-stroke).
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing two interventions to help reduce the impact of stroke-related arm movement impairment.

Who is the study for?
This trial is for individuals aged 18-85 who've had a stroke within the last 90 days, can consent to participate, and have mild-to-moderate difficulty with language. They should have weakness on one side of their body but be able to follow simple commands with their unaffected arm. People with pre-existing disabilities in their arms, certain brain lesions, medical conditions that limit movement assessments, chronic neurological issues other than stroke, or pain that affects movement cannot join.
What is being tested?
The study tests two therapies aimed at improving arm reach after a stroke by preventing 'flexion synergy,' which restricts outward arm movement. Participants will receive either Supported Reaching or Abduction Loading therapy along with standard rehab treatments over a year and will be monitored to see which method is more effective.
What are the potential side effects?
Since this trial involves physical therapy interventions rather than drugs, typical side effects might include muscle soreness or fatigue from the exercises. However, specific side effects are not listed as they generally depend on individual tolerance and response to physical therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have weakness on one side of my body.
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I can follow a 3-step command with my arm that is not affected.
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I had a stroke affecting the middle part of my brain.
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I have no or mild-to-moderate difficulty speaking.
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I understand and can agree to the study's procedures and risks.
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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have long-term difficulty using my arms or hands.
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I have a tumor in my brainstem or cerebellum.
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I experience pain or sensitivity that affects my ability to move.
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I have swelling in my limbs that could interfere with movement tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in reaching function will be modeled from baseline, weekly (until discharge from rehabilitation, on average 4 to 10 weeks), and monthly evaluations (every-other month until 12 months post-stroke).
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in reaching function will be modeled from baseline, weekly (until discharge from rehabilitation, on average 4 to 10 weeks), and monthly evaluations (every-other month until 12 months post-stroke). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Reaching Function
Secondary study objectives
Change in Action Research Arm Test
Change in Fugl-Meyer Motor Assessment
Change in Loss of Independent Joint Control
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Abduction LoadingExperimental Treatment1 Intervention
The intervention for the experimental group entails practicing reaching with abduction loading.
Group II: Supported ReachingActive Control1 Intervention
The intervention for the active comparator entails practicing reaching while supported.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,747,621 Total Patients Enrolled
86 Trials studying Stroke
5,677 Patients Enrolled for Stroke
Northwestern UniversityLead Sponsor
1,652 Previous Clinical Trials
961,429 Total Patients Enrolled
34 Trials studying Stroke
25,345 Patients Enrolled for Stroke
Marianjoy Rehabilitation Hospital & ClinicsOTHER
1 Previous Clinical Trials
1 Total Patients Enrolled
1 Trials studying Stroke
1 Patients Enrolled for Stroke
Shirley Ryan AbilityLabOTHER
208 Previous Clinical Trials
17,839 Total Patients Enrolled
74 Trials studying Stroke
8,681 Patients Enrolled for Stroke
Michael D Ellis, PT, DPTPrincipal InvestigatorNorthwestern University
1 Previous Clinical Trials
38 Total Patients Enrolled
1 Trials studying Stroke
38 Patients Enrolled for Stroke

Media Library

Abduction Loading Clinical Trial Eligibility Overview. Trial Name: NCT04118998 — N/A
Stroke Research Study Groups: Abduction Loading, Supported Reaching
Stroke Clinical Trial 2023: Abduction Loading Highlights & Side Effects. Trial Name: NCT04118998 — N/A
Abduction Loading 2023 Treatment Timeline for Medical Study. Trial Name: NCT04118998 — N/A
~14 spots leftby Aug 2025
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