Home Exercise for Individuals With Neurodegenerative Disease

Study Overview
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Brief Summary
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The primary goal of this study is to address the need for targeted therapeutic interventions for impairments that impact walking in related neurodegenerative diseases.

Detailed Description
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This study will inform clinicians in quantitatively assessing baseline disease severity, selectively applying the appropriate exercise to the disease pathology, and measuring efficacy of the exercise intervention. As part of this overall goal, the aims are to: A. Determine feasibility of remotely supervised exercise programs. B. Optimize remote outcome measures for clinical monitoring and towards future clinical trials. C. Measure changes in balance and walking post intervention.

Official Title
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Study of Adapted Exercise and Mindfulness Interventions to Improve Motor Function and Sleep Quality in Individuals With Neurodegenerative Disease

Conditions
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Neurodegenerative Diseases, Leukodystrophy, Ataxia

Intervention / Treatment
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* Behavioral: Home exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The eligibility criteria for males is X-linked adrenoleukodystrophy as determined by biochemical determination or genetic testing. The eligibility criteria for females is X-linked adrenoleukodystrophy as determined by biochemical determination, genetic testing, or pedigree analysis. The Leukoenceophalopathy with brainstem and spinal cord involvement and lactate elevation inclusion criterion is a confirmed DARS2 mutation through genetic analysis. For people with cerebellar ataxia, people with diagnoses of cerebellar damage from stroke, tumor or degeneration will be included. Those with a genetically confirmed cerebellar disorder will be asked to provide their genetic testing to note their particular type of ataxia. We will also include patients with other neurodegenerative diseases similar to these disorders as determined by chart review and clinical exam. Healthy Volunteers Able to stand for 30 seconds without upper extremity support Ambulatory (including use of a cane or a walker) Able to walk for 2 minutes Exclusion Criteria: Other medical or psychological conditions which in the clinical judgement of the investigator would interfere with acquiring the study information or performing the exercises safely including but not limited to: Uncontrolled hypertension, orthopedic conditions, diabetes, seizure disorder, peripheral vestibular loss, severe aphasia, dementia, pregnancy

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pre-test post-test design. Based on pre-test assessments participants will be instructed in an individualized exercise program. Participants will participate in 18 hours of remotely supervised and home practice exercises.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home exercise<br>Individually designed home exercise program | Behavioral: Home exercise<br>* Exercise to address limitations impacting walking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NeuroQOL lower extremity | Patient reported outcome | baseline 12 weeks |