Actively Recruiting

Phase Not Applicable
Age: 5Years - 75Years
All Genders
Healthy Volunteers
ID05443906

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

Led by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Updated on 2025-03-10

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating targeted therapeutic exercises for individuals with neurodegenerative diseases that affect walking. The study aims to improve how clinicians assess disease severity, apply exercise interventions that match the disease pathology, and measure the impact on balance and walking. The research focuses on conditions such as leukodystrophy, ataxia, LBSL, and adrenomyeloneuropathy among others. Participants will engage in an individually designed home exercise program focused on addressing walking impairments. This program will be remotely supervised to test the feasibility of such interventions and to optimize outcome measures that can be used in clinical monitoring and future trials. The exercise intervention will be tailored to each participant's condition and delivered in a home setting. During the study, participants will be assessed on changes in motor function and sleep quality using tools like the NeuroQOL lower extremity measure over a 12-week period. Researchers will monitor balance and walking improvements as well as the feasibility of remote supervision. The study includes healthy volunteers who can stand and walk for specific durations and involves ongoing clinical evaluations to ensure safety and measure progress. Total participation duration and follow-ups are designed to support these goals.

CONDITIONS

Brief Title

Home Exercise for Individuals with Neurodegenerative Disease

Who Can Participate

Age: 5Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males diagnosed with X-linked adrenoleukodystrophy confirmed by biochemical or genetic testing
  • Females diagnosed with X-linked adrenoleukodystrophy confirmed by biochemical, genetic testing, or pedigree analysis
  • Confirmed DARS2 mutation through genetic analysis for Leukoencephalopathy with brainstem and spinal cord involvement and lactate elevation
  • Diagnosis of cerebellar damage from stroke, tumor, or degeneration, or genetically confirmed cerebellar disorder with documentation
  • Patients with other similar neurodegenerative diseases determined by chart review and clinical exam
  • Healthy volunteers able to stand for 30 seconds without upper extremity support
  • Ambulatory individuals including those using a cane or walker
  • Able to walk for 2 minutes
Not Eligible

You will not qualify if you...

  • Medical or psychological conditions that interfere with study participation or safe exercise performance as judged by the investigator
  • Conditions include uncontrolled hypertension, orthopedic problems, diabetes, seizure disorder, peripheral vestibular loss, severe aphasia, dementia, pregnancy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 12 weeks

Participants follow an individually designed home exercise program to improve motor function and walking ability.

Weekly visits for up to 12 weeks

Trial Site Locations

Total: 1 location

1

Kennedy Krieger Institute

Baltimore, Maryland, United States, 21205

Actively Recruiting

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Research Team

J

Jennifer L Keller, PT, MS

A

Amena Smith Fine, MD PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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