Home Exercise for Individuals with Neurodegenerative Disease

NCT05443906 | Recruiting

• 1 other identifier: JHSOM_IRB00309985
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in NeuroQOL lower extremity

  Patient reported outcome

  baseline 12 weeks

Study Arms (1)

Home exercise

EXPERIMENTAL

Individually designed home exercise program

Behavioral: Home exercise

Interventions

Home exercise BEHAVIORAL

Exercise to address limitations impacting walking

Home exercise

Eligibility Criteria

• Age: 5 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Neurodegenerative Diseases; Ataxia; Leukoencephalopathy with Brainstem and Spinal Cord Involvement and Lactate Elevation; Cerebellar Ataxia; Adrenoleukodystrophy

Condition Hierarchy (Ancestors)

Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Hereditary Central Nervous System Demyelinating Diseases; Leukoencephalopathies; Demyelinating Diseases; X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heredodegenerative Disorders, Nervous System; Metabolism, Inborn Errors; Peroxisomal Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Insufficiency; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Jennifer Keller, PT

  Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer L Keller, PT, MS

CONTACT

443-923-2716; keller@kennedykrieger.org

Amena Smith Fine, MD PhD

CONTACT

443-923-3249; finea@kennedykrieger.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: July 5, 2022
• Study Start: February 13, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)