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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05685095
Other study ID # 38RC22.0105_ACTI-PARK
Secondary ID 2022-A00678-35
Status Withdrawn
Phase N/A
First received
Last updated
Start date February 2023
Est. completion date October 2026

Study information

Verified date April 2023
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this randomized controlled pilot trial is to assess the impact of different gait rehabilitation programs on the level of physical activity and gait in daily life in patients with Parkinson's disease (PD). Two groups of 25 patients with PD will benefit from one of two gait training programs (treadmill vs. nordic walking), 3 times a week for 12 weeks. Activity level and number of steps will be remotely recorded over 7 days before, at the end, 3 and 6 months after the end of the program. Quality of life will be recorded at each time point. The impact of the gait programs on the patients' level of daily activity will be examined, comparing the changes brought about by the two programs, taking into account the modulating influence of age and cognitive function. Gait under conditions of daily life will be compared to gait parameters collected in the laboratory.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2026
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility Inclusion Criteria: - Parkinson's disease, diagnosed for at least 2 years, - Medical treatment (if any) unchanged in the past 4 weeks at least - Hoehn & Yahr score < 3 - Montreal cognitive assessment (MOCA) score between 20 and 30 - Able to understand the aim and methods of the study and provide signed informed consent- Exclusion Criteria: - Atypical parkinsonian syndrome - Cardiovascular pathology preventing moderate physical exercise - Orthostatic hypotension - Any condition (other than PD) interfering with gait - pregnant or nursing

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical training
Supervised gait training program 3 times a week, 12 weeks

Locations

Country Name City State
France CHU Grenoble Alpes Grenoble

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Grenoble Institut National de la Santé Et de la Recherche Médicale, France, University Grenoble Alps

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in daily energy expenditure Evolution over time of the daily energy expenditure together with number of steps, as recorded using an actimeter worn at the belt. recording 7 days in a row, at 3 months, 6 months and 9 months.
Secondary Evolution of gait parameters Evolution over time of spatio-temporal gait parameters recorded during a gait test in the laboratory. 3 months, 6 months and 9 months.
Secondary Evolution of exercise functional capacity Evolution over time of the patients' performance at the 6 minutes walk test 3 months, 6 months and 9 months.
Secondary Evolution over time of the Parkinson's Disease Questionnaire-39 scale score. Evolution of quality of life as measured using the PDQ.39 scale. Summed item scores expressed as percent. Min 0 Max 100. 3 months, 6 months and 9 months.
Secondary Evolution over time of the Parkinsons' Disease Fatigue Scale score. Evolution of fatigue as measured using the PD Fatigue scale. Min 0. Max 80. Greater score means greater fatigue 3 months, 6 months and 9 months.
Secondary Adherence to the training program number of training sessions attended 3 months
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