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Home Exercise for Individuals With Neurodegenerative Disease

Primary Purpose

Neurodegenerative Diseases, Leukodystrophy, Ataxia

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Home exercise

About this trial

This is an interventional treatment trial for Neurodegenerative Diseases

Eligibility Criteria

5 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Kennedy Krieger InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home exercise

Arm Description

Individually designed home exercise program

Outcomes

Primary Outcome Measures

Change in NeuroQOL lower extremity

Patient reported outcome

Secondary Outcome Measures

Full Information

NCT ID

NCT05443906

First Posted

May 11, 2022

Last Updated

February 15, 2023

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT05443906

Brief Title

Home Exercise for Individuals With Neurodegenerative Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 13, 2023 (Actual)

Primary Completion Date

July 30, 2026 (Anticipated)

Study Completion Date

July 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurodegenerative Diseases, Leukodystrophy, Ataxia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Home exercise

Arm Type

Experimental

Arm Description

Individually designed home exercise program

Intervention Type

Behavioral

Intervention Name(s)

Home exercise

Intervention Description

Exercise to address limitations impacting walking

Primary Outcome Measure Information:

Title

Change in NeuroQOL lower extremity

Description

Patient reported outcome

Time Frame

baseline 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dandre Amos, BS

Phone

443-923-2769

amosd@kennedykrieger.org

First Name & Middle Initial & Last Name or Official Title & Degree

Amena Smith Fine, MD PhD

Phone

443-923-3249

finea@kennedykrieger.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Keller, PT

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kennedy Krieger Institute

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dandre Amos, BS

Phone

443-923-2769

amosd@kennedykrieger.org

First Name & Middle Initial & Last Name & Degree

Jennifer Keller, PT

Phone

4439232716

keller@kennedykrieger.org

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26863451

Citation

Keller JL, Fritz N, Chiang CC, Jiang A, Thompson T, Cornet N, Newsome SD, Calabresi PA, Zackowski K. Adapted Resistance Training Improves Strength in Eight Weeks in Individuals with Multiple Sclerosis. J Vis Exp. 2016 Jan 29;(107):e53449. doi: 10.3791/53449.

Results Reference

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Home Exercise for Individuals With Neurodegenerative Disease

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