Feasibility Study of the Taïso Practice in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Taïso

• Registration Number: NCT04045925
• Lead Sponsor: University Hospital, Angers

Brief Summary

This is a pilot study of descriptive and analytical, prospective feasibility, monocentric, longitudinal with 6 months of bi-weekly practice of Taïso in patients with Parkinson's disease with mild to moderate postural instability.

The intervention is planned over 6 months (25 consecutive weeks) for the whole project of the patient group. Patients are included in the month before the start of the treatment of the intervention. Four standardized evaluation sessions are conducted: a first evaluation during the first week of Taiso and then every 8 weeks (2 months, 4 months and 6 months). Incident collection and fitness assessment tests are performed by the physical trainer while the balance and are performed by a physiotherapist. The quality of life assessment and the MDS-UPDRS II rating are performed during the inclusion visit and then the final study visit (within 2 weeks) after 6 months of practice) with the coordinating neurologist. An evaluation of incidents is also carried out during this end-of-study visit.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-06
• Study Start: 2020-09-09
• Primary Completion: 2020-10-07
• Study Completion: 2021-04-07
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Age ≥18 and <85 years old,
• Parkinson's disease diagnosed by a neurologist, treated and sensitive to dopaminergic treatment without limitation of the duration of the disease since the date of diagnosis,
• Patient with mild to moderate postural instability (equivalent to grade 2.5 and 3 on the Hoehn and Yahr scale),
• Naive patient of any practice of Taiso,
• Patient available to perform the Taïso program planned in the study,
• Patient with written informed consent

Exclusion Criteria

• Patient with a contraindication to the practice of sport
• Pregnant woman, parturient and breastfeeding mother
• Patient deprived of liberty by administrative or judicial decision
• Patient admitted to a health or social facility for purposes other than that of research
• Adults under guardianship or trusteeship or unable to express consent
• Patient not affiliated to a social security system
• Patient already participating in a therapeutic research protocol that aims to improve physical or mental abilities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Taïso practice	Taïso	6 months of biweekly practice Taïso

Primary Outcome Measures

Name	Time	Method
Number of traumatic incident(s) and/or cardiovascular(s)	The collection of traumatic and/or cardiovascular incidents will begin in the first Taiso class and continue until the final visit with the neurologist (6 months of collection	The main judgement criterion is the number of traumatic incident(s) and/or cardiovascular(s) during Taiso practice and on journeys between home and the site of practice until the end of patient participation in the study.

Trial Locations

Locations (1)

CHU d'Angers; 🇫🇷 Angers, France