Feasibility Study of the Taïso Practice in Parkinson's Disease

NCT04045925 | Completed

• 1 other identifier: 2019-A01551-56
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Taïso; Physical therapy; Exercice therapy; Parkinson disease

Outcome Measures

Primary Outcomes (1)

• Number of traumatic incident(s) and/or cardiovascular(s)

  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.

  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

Study Arms (1)

Taïso practice

EXPERIMENTAL

6 months of biweekly practice Taïso

Other: Taïso

Interventions

Taïso OTHER

Taiso is a physical preparation practice of which the French Judo Federation is a state delegate. It is practiced in most French dojos. During each course, Taiso's practice works the fundamental motor skills (coordination, static and dynamic balance, locomotion and grip), muscle strengthening, target work by simulated attacks-defenses exercises without blows or projections, relaxation and the specific work of knowledge to fall and rise with graduation and progressivity in the intensity and complexity of the exercises as and when practiced.

Taïso practice

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU d'Angers

Angers, 49000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 6, 2019
• Study Start: September 9, 2020
• Primary Completion: October 7, 2020
• Study Completion: April 7, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

FR (1)