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Home Exercise for Individuals With Neurodegenerative Disease

Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05443906
Collaborator
(none)
30
Enrollment
1
Arm
58.3
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Home exercise
 N/A

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:

  1. Determine feasibility of remotely supervised exercise programs. B. Optimize remote outcome measures for clinical monitoring and towards future clinical trials.

  2. Measure changes in balance and walking post intervention.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Study of Adapted Exercise and Mindfulness Interventions to Improve Motor Function and Sleep Quality in Individuals With Neurodegenerative Disease
Anticipated Study Start Date :
Sep 21, 2022
Anticipated Primary Completion Date :
Jul 30, 2026
Anticipated Study Completion Date :
Jul 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Home exercise

Individually designed home exercise program

Behavioral: Home exercise
Exercise to address limitations impacting walking

Outcome Measures

Primary Outcome Measures

  1. Change in NeuroQOL lower extremity [baseline 12 weeks]

    Patient reported outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Jennifer Keller, PT, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
jennifer keller, Physical Therapist, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT05443906
Other Study ID Numbers:
  • JHSOM_IRB00309985
First Posted:
Jul 5, 2022
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neurodegenerative Diseases

Study Results

No Results Posted as of Aug 16, 2022