N/A
Completed N=26
Feasibility and Preliminary Effects of MR-005 in Persons With Parkinson Disease
Source: ClinicalTrials.gov NCT04891107 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Observed Adherence (Feasibility) to Walking Program Schedule Based on Percentage of Scheduled Sessions Completed — 86.08696 percent of sessions completed
Summary
The purpose of this clinical study is to evaluate the effects of music, tailored to the participant's cadence, on adherence, quality of life, gait speed, functional mobility, and walking activity in individuals with Parkinson disease when used in the home and community environment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Observed Adherence (Feasibility) to Walking Program Schedule Based on Percentage of Scheduled Sessions Completed |
86.08696 | — |
| PRIMARY Safety (Feasibility) Based on the Number of Adverse Events During Training |
— | — |
| PRIMARY Usability (Feasibility) Based on Participant Ratings on Acceptability and Usability Questionnaire. |
21.06; 13.37; 65.57 | — |
| PRIMARY Change in Mobility Impact Based on the Mobility Dimension of the Parkinson's Disease Questionnaire-39 (PDQ-39) Between Baseline to Last Visit |
-1.81 | — |
| SECONDARY Change in Disease Severity Based on the Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) |
-3.67 | — |
| SECONDARY Change in Walking Endurance (m) |
13.83 | — |
| SECONDARY Change in Fast Walking Gait Speed (m/s) |
0.001 | — |
| SECONDARY Overall Quality of Life Impact Based on the Total Parkinson's Disease Questionnaire -39 (PDQ-39) |
-2.68 | — |
| SECONDARY Change in Mobility |
-1.46 | — |
| SECONDARY Change in Amount of Walking (Steps/Day) |
3484 | — |
| SECONDARY Change in Intensity (Moderate Intensity Minutes; >100 Steps/Min) |
21.44 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of idiopathic, typical Parkinson disease.
- Modified Hoehn and Yahr stages 1-3 per physical exam.
- Able to walk independently without physical assistance or an assistive device.
Exclusion Criteria
- Diagnosis of atypical Parkinsonism.
- Moderately or significantly disturbing freezing episodes during daily walking.
- Cognitive impairment as determined by the Montreal Cognitive Assessment (MoCA).
- Significant hearing impairment.
- Currently participating in physical therapy.
- Cardiac problems that interfere with the ability to safely exercise.
- Orthopedic problems in the lower extremities or spine that may limit walking distance.
Data sourced from ClinicalTrials.gov (NCT04891107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.