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RecruitingNCT05443906Updated Sep 16, 2026

Home Exercise for Individuals With Neurodegenerative Disease

An interventional study of Home exercise in Neurodegenerative Diseases, Leukodystrophy and Ataxia, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. Recruiting at 1 site in United States. Open to participants aged 5 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
5 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Neurodegenerative Diseases
  • Leukodystrophy
  • Ataxia
  • LBSL
  • Leukoencephalopathy With Brain Stem and Spinal Cord Involvement and High Lactate Syndrome (Disorder)
  • Leukoencephalopathy With Brainstem and Spinal Cord Involvement and Lactate Elevation
  • Cerebellar Ataxia
  • Adrenomyeloneuropathy
03

In context

Neurodegenerative Diseases

436 studies on the registry are indexed under Neurodegenerative Diseases; 143 are open to participants now.

This study's planned enrollment of 30 is below the median of 54 across 265 interventional studies indexed under Neurodegenerative Diseases.

Browse Neurodegenerative Diseases studies →

Lead sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc. is the lead sponsor of 76 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Home exercise

    Individually designed home exercise program

    Behavioral: Home exercise

Interventions

  • BehavioralHome exercise

    Exercise to address limitations impacting walking

06

What researchers measure

Primary outcomes

  1. Change in NeuroQOL lower extremity

    Patient reported outcome

    Time frame: baseline 12 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05443906
Lead sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Responsible party
jennifer keller (Physical Therapist, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.) — Principal investigator
First posted
Jul 5, 2022
Start date
Feb 13, 2023
Primary completion
Jul 30, 2028 (estimated)
Completion
Jul 30, 2028 (estimated)
Last update
Sep 16, 2026

Study contacts

Jennifer L Keller, PT, MS
Contact
keller@kennedykrieger.org
443-923-2716
Amena Smith Fine, MD PhD
Contact
finea@kennedykrieger.org
443-923-3249
Jennifer Keller, PT
principal investigator · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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