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Clinical Trials/NCT05443906
NCT05443906
Recruiting
Not Applicable

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

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.1 site in 1 country30 target enrollmentStarted: February 13, 2023Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
1
Primary Endpoint
Change in NeuroQOL lower extremity

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
5 Years to 75 Years (Child, Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Change in NeuroQOL lower extremity

Time Frame: baseline 12 weeks

Patient reported outcome

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

jennifer keller

Physical Therapist

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

Study Sites (1)

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