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Rehabilitation for ALS
N/A
Waitlist Available
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of ALS with an SOD1 mutation
Age greater than 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial studies the effects of personalized rehabilitation programs on people with SOD1 ALS who are receiving treatment with tofersen. They will get assessments and individualized therapy. Assessments will happen every 3 months.
Who is the study for?
This trial is for adults over 18 with ALS caused by an SOD1 mutation who are already getting Tofersen treatment. They must be medically cleared to do outpatient or home-based rehab. People can't join if they have other health issues that make physical therapy too risky.Check my eligibility
What is being tested?
The study is testing a personalized rehabilitation program for ALS patients on Tofersen. It includes assessments and prescribed exercises in outpatient sessions or at home, with progress checks every three months.See study design
What are the potential side effects?
Since the intervention focuses on rehabilitation rather than medication, side effects may include muscle soreness, fatigue, and potential injury from physical activities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have ALS with an SOD1 mutation.
Select...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS)
Secondary outcome measures
1. Change from baseline in Handheld Dynamometry (HHD)
2. Change from baseline in Rasch-Built Overall Amyotrophic Lateral Sclerosis Functional Rating (ROADS)
3. Change from baseline in ALS Assessment Questionnaire, 5-item (ALSAQ-5)
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Rehabilitation ArmExperimental Treatment1 Intervention
Participants will participate in outpatient physical and/or occupational therapies while participating in the tofersen early access program (EAP)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rehabilitation
2014
Completed Phase 2
~2490
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,685 Total Patients Enrolled
7 Trials studying Amyotrophic Lateral Sclerosis
1,973 Patients Enrolled for Amyotrophic Lateral Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently enrolled in a program to receive tofersen outside of a clinical trial.I have ALS with an SOD1 mutation.I am older than 18 years.My doctor thinks it's too risky for me to do outpatient physical therapy or home rehab.My doctor says I can do physical therapy or rehab at home.
Research Study Groups:
This trial has the following groups:- Group 1: Rehabilitation Arm
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.
Are there still openings to participate in this clinical experiment?
"Unfortunately, the medical trial hosted on clinicaltrials.gov is no longer actively recruiting candidates. Initially posted in November 8th 2022 and last updated February 10th 2023, this study has ceased enrollment of patients; however, 520 other trials are accepting participants at present."
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