Back to resultsFeasibility Study of the Taïso Practice in Parkinson's Disease (Taïso-Park)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Taïso
Sponsored by
About this trial
This is an interventional screening trial for Parkinson Disease focused on measuring Taïso, Physical therapy, Exercice therapy, Parkinson disease
Eligibility Criteria
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
Sites / Locations
- CHU d'Angers
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Taïso practice
Arm Description
6 months of biweekly practice Taïso
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04045925
First Posted
August 2, 2019
Last Updated
July 21, 2021
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT04045925
Brief Title
Feasibility Study of the Taïso Practice in Parkinson's Disease
Acronym
Taïso-Park
Official Title
Feasibility Study of the Taïso Practice in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
April 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Taïso, Physical therapy, Exercice therapy, Parkinson disease
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Taïso practice
Arm Type
Experimental
Arm Description
6 months of biweekly practice Taïso
Intervention Type
Other
Intervention Name(s)
Taïso
Intervention Description
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 Outcome Measure Information:
Title
Number of traumatic incident(s) and/or cardiovascular(s)
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study of the Taïso Practice in Parkinson's Disease
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