Parkinson DiseaseTaïso-ParkNCT04045925
Feasibility Study of the Taïso Practice in Parkinson's Disease
A study testing Taïso in people with Parkinson Disease, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Taïso
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2020to 7 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Taïso
- Keywords
- Taïso, Physical therapy, Exercice therapy, Parkinson disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaïsoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Taïso practice | Experimental | 6 months of biweekly practice Taïso Receives: Other: Taïso |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start9 Sep 2020
- Primary completion7 Oct 2020
- Study completion7 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045925
- Sponsor's protocol ID
- 2019-A01551-56
- Acronym
- Taïso-Park
- Status last verified
- Jul 2021
- First submitted
- 2 Aug 2019
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Taïso Practice in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04045925
- Acronym / sponsor ID
- Taïso-Park / 2019-A01551-56
- Conditions
- Parkinson Disease
- Keywords
- Taïso, Physical therapy, Exercice therapy, Parkinson disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taïso practice | Experimental | Other: Taïso6 months of biweekly practice Taïso |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TaïsoTaiso 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. | Other | Taïso practice |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taïso in people with Parkinson Disease, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.