Home Exercise for Individuals with Neurodegenerative Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Home exercise.
- Who it may be relevant to
- Registry conditions: Neurodegenerative Diseases, Leukodystrophy, Ataxia, LBSL. Basic parameters: 5 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study of Adapted Exercise and Mindfulness Interventions to Improve Motor Function and Sleep Quality in Individuals with Neurodegenerative Disease
Overview
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
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.
Interventions
- Behavioral Home exercise
Exercise to address limitations impacting walking
Primary outcome measures
- Change in NeuroQOL lower extremity [Time frame: baseline 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Kennedy Krieger Institute — Baltimore
Identifiers
NCT: NCT05443906 · JHSOM_IRB00309985