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OpenTrials
Completed

NCT Number: NCT04045925

Feasibility Study of the Taïso Practice in Parkinson's Disease

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'Angers

Angers, 49000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of traumatic incident(s) and/or cardiovascular(s)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: Taïso-Park

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Aug 6, 2019
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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