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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
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
PRALINE Trial 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.Check my eligibility
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.See study design
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.
PRALINE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
I had a stroke affecting the middle part of my brain.
Select...
I have no or mild-to-moderate difficulty speaking.
Select...
I understand and can agree to the study's procedures and risks.
Select...
I am between 18 and 85 years old.
PRALINE Trial Timeline
Screening ~ 3 weeks3 visits
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).
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).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Reaching Function
Secondary outcome measures
Change in Action Research Arm Test
Change in Fugl-Meyer Motor Assessment
Change in Loss of Independent Joint Control
+1 morePRALINE 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?
Shirley Ryan AbilityLabOTHER
194 Previous Clinical Trials
16,826 Total Patients Enrolled
70 Trials studying Stroke
8,259 Patients Enrolled for Stroke
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,711 Total Patients Enrolled
79 Trials studying Stroke
5,301 Patients Enrolled for Stroke
Northwestern UniversityLead Sponsor
1,588 Previous Clinical Trials
917,015 Total Patients Enrolled
30 Trials studying Stroke
25,119 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have long-term difficulty using my arms or hands.I have weakness on one side of my body.You have no or slight problems with paying attention and noticing things.I have a tumor in my brainstem or cerebellum.I can follow a 3-step command with my arm that is not affected.I experience pain or sensitivity that affects my ability to move.You have a medical condition that makes it unsafe to perform tests of movement and coordination.I had a stroke affecting the middle part of my brain.I have no or mild-to-moderate difficulty speaking.I have swelling in my limbs that could interfere with movement tests.I had a stroke less than 90 days ago.I understand and can agree to the study's procedures and risks.You have any other long-term neurological condition.I am between 18 and 85 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Abduction Loading
- Group 2: Supported Reaching
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is this study recruiting?
"Affirmative, the information on clinicaltrials.gov shows that this trial is currently accepting participants. The initiative was launched on August 27th 2021 and underwent its latest ammendments as of February 10th 2022; 86 individuals are needed from two seperate facilities."
Answered by AI
Is the eligibility for this clinical trial restricted to adults aged 18 and above?
"As per the prerequisites of this trial, potential participants need to be between 18 years old and 85 years old."
Answered by AI
Do I meet the requirements to join this medical experiment?
"The researchers are looking for 86 individuals with stroke, aged 18 and 85. They must possess hemiparesis confined to one side (as judged by the CMSA's 7-point scale), have suffered a stroke in the middle cerebral artery distribution, be able to follow 3-step motor commands using their unaffected arm, and provide informed consent."
Answered by AI
Are there any opportunities to volunteer for the research at this time?
"Drawing from the clinicaltrials.gov page, this trial is currently seeking volunteers and has been doing so since August 27th 2021 with an update on February 10th 2022."
Answered by AI
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