Can home exercise and mindfulness help people with rare brain diseases walk and sleep better?

NCT ID NCT05443906

Symptom relief Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Source: ClinicalTrials.gov ↗

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing whether a home-based program combining adapted exercise and mindfulness training can improve walking ability and sleep quality in people with rare neurodegenerative diseases such as leukodystrophy, ataxia, and adrenomyeloneuropathy. The study enrolls about 30 participants who complete the program at home. The goal is to see if this low-cost approach helps with movement and sleep problems that these conditions cause.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: adapted home exercise and mindfulness training
What this could lead to: If the approach helps, it could offer a low-cost, home-based way to support walking and sleep for people with these rare neurodegenerative conditions.
What could go wrong: This is a small study of 30 people with several different rare diseases, so results may not apply broadly. Exercise and mindfulness carry little risk, but benefits may be modest or hard to measure.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

adrenoleukodystrophy adrenomyeloneuropathy Ataxia cerebellar ataxia leukodystrophy leukoencephalopathy with brain stem and spinal cord involvement-high lactate syndrome neurodegenerative disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adrenomyeloneuropathy Ataxia Cerebellar ataxia LBSL Leukodystrophy Leukoencephalopathy with brain stem and spinal cord involvement and high lactate syndrome (disorder) Leukoencephalopathy with brainstem and spinal cord involvement and lactate elevation Neurodegenerative diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can home exercise and mindfulness help people with rare brain diseases walk and sleep better?

What the study statuses mean