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Exercise Training Program for Cerebellar Ataxia
Baltimore, MD
N/A
Waitlist Available
Led By Amy J Bastian, PhD, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants are assessed at baseline (week 1 and week 3), mid-training (week 6), and post-training (week 9 and week 13). there are a total of 13 weeks for this study with 5 visits during that time period
Awards & highlights
No Placebo-Only Group
Summary
The purpose of this study is to determine whether a person's ability to adapt (i.e. short term motor learning) predicts their ability to benefit from physical therapy exercises.
See full description
Eligible Conditions
- Congenital Cerebellar Ataxias
- Cerebellar Ataxia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ participants are assessed at baseline (week 1 and week 3), mid-training (week 6), and post-training (week 9 and week 13). there are a total of 13 weeks for this study with 5 visits during that time period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants are assessed at baseline (week 1 and week 3), mid-training (week 6), and post-training (week 9 and week 13). there are a total of 13 weeks for this study with 5 visits during that time period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in walking speed from baseline to mid-training and to post-training
Side effects data
From 2023 Phase 3 trial • 129 Patients • NCT0293892317%
Arthralgia
13%
Contusion
11%
Musculoskeletal pain
9%
Diarrhea
9%
Nausea
7%
Back pain
7%
Hypotension
7%
Urinary tract infection
7%
Joint swelling
7%
Dizziness
6%
Neck pain
6%
Pain in extremity
6%
Upper respiratory tract infection
6%
Blood pressure increased
6%
Myalgia
4%
Hypertension
2%
Sepsis
2%
Hip Fracture
2%
Chest pain
2%
Kidney fibrosis
2%
Fractured sacrum
2%
Lumbar vertebral fracture
2%
Transient ischemic attack
2%
Cholelithiasis
2%
Constipation
2%
Vomiting bile
2%
Musculoskeletal chest pain
2%
Rash pruritic
2%
Ruptured diverticulum of colon
2%
Acute respiratory failure
2%
Diverticulum intestinal
100%
80%
60%
40%
20%
0%
Study treatment Arm
Exercise + Placebo (EX + P)
Exercise + Testosterone (EX + T)
Enhanced Usual Care (EUC)
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 exercise programExperimental Treatment1 Intervention
Balance and walking exercise program
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Home exercise program
2017
Completed Phase 3
~1280
Find a Location
Closest Location:Motion Analysis Lab in the Kennedy Krieger Institute· Baltimore, MD
Who is running the clinical trial?
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
91 Previous Clinical Trials
25,035 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,089 Previous Clinical Trials
2,746,349 Total Patients Enrolled
Amy J Bastian, PhD, PTPrincipal InvestigatorKennedy Krieger Institute and Johns Hopkins School of Medicine
4 Previous Clinical Trials
152 Total Patients Enrolled