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Home Exercise for Neurodegenerative Disease
N/A
Recruiting
Led By Jennifer Keller, PT
Research Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For females: X-linked adrenoleukodystrophy as determined by biochemical determination, genetic testing, or pedigree analysis
Leukoencephalopathy with brainstem and spinal cord involvement and lactate elevation inclusion criterion: confirmed DARS2 mutation through genetic analysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trialaims to develop treatments that improve walking ability in people with neurodegenerative diseases.
Who is the study for?
This trial is for individuals with specific neurodegenerative diseases like ataxia, leukodystrophy, or those with cerebellar damage due to stroke or tumor. Participants must have a confirmed genetic mutation related to their condition, be able to stand and walk with or without support, and not have other health issues that could interfere with the exercise program.
What is being tested?
The study tests a home exercise regimen designed to improve walking abilities in people suffering from neurodegenerative diseases. It aims to create targeted therapeutic interventions tailored for these conditions.
What are the potential side effects?
Since this trial involves home exercises, side effects may include muscle soreness, fatigue, and an increased risk of falls if exercises are not performed safely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a female diagnosed with X-linked adrenoleukodystrophy.
Select...
I have a confirmed DARS2 mutation linked to my leukoencephalopathy.
Select...
I am a male diagnosed with X-linked adrenoleukodystrophy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in NeuroQOL lower extremity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Home exerciseExperimental Treatment1 Intervention
Individually designed home exercise program
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Home exercise
2017
Completed Phase 2
~1740
Find a Location
Who is running the clinical trial?
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
90 Previous Clinical Trials
24,830 Total Patients Enrolled
Jennifer Keller, PTPrincipal InvestigatorHugo W. Moser Research Institute at Kennedy Krieger, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a female diagnosed with X-linked adrenoleukodystrophy.I can stand and walk without much help.I have cerebellar ataxia due to stroke, tumor, or degeneration, or I have a genetically confirmed cerebellar disorder.I have a confirmed DARS2 mutation linked to my leukoencephalopathy.I am a male diagnosed with X-linked adrenoleukodystrophy.
Research Study Groups:
This trial has the following groups:- Group 1: Home exercise
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.