Parkinson DiseaseTeleParkinsonNCT03985631
Tai Chi Intervention by Telerehabilitation
A study testing Rehabilitation intervention in people with Parkinson Disease, run by Université de Sherbrooke at 2 sites in Canada.
Trial summary
Rational : A lot of people in the province of Quebec suffer from Parkinson's disease and they are mostly vulnerable because they gradually lose their autonomy with the worsening of the disease. Physiotherapy was proven to be an effective treatment method for these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Rehabilitation intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesCanada
- Study dates
- 22 Jan 2020to 6 Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- to be diagnosed with Parkinson Disease according to the " Movement Disorders Society's diagnostic criteria " for at least 3 years
- Presence of a postural instability measured by the pull test according to Movement Disorders Society-Sponsored revision scale of Unified Parkinson Disease Rating scale " (MDS-UPDRS) with a score to item 3, 12 ≥ 1,
- Have access to Internet
- Have a caregiver available during rehabilitation sessions
Who cannot join
- Have a une cognitive impairment measured by the " Mini-Mental State Examination " (MMSE), with a total score < 24.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Université de Sherbrooke
Sherbrooke, Quebec, J1K 2R1
Research Centre on Aging
Sherbrooke
About this study
Official title: Tai Chi Intervention by Telerehabilitation as an Innovative Solution for Parkinson's Disease Population
Rational : A lot of people in the province of Quebec suffer from Parkinson's disease and they are mostly vulnerable because they gradually lose their autonomy with the worsening of the disease. Physiotherapy was proven to be an effective treatment method for these patients. However, accessibility to care remains a major issue.
Objective: This project aims to establish the clinical feasibility of a Tai chi rehabilitation program through tele rehabilitation to patients suffering of Parkinson's disease.
Read more
Methodology : This pilot study will be conduct with a pre/post-test device. Therefore, to reach the objective, an evaluation will be done before the intervention and directly after the end of the 12 weeks program. Also, the obstacles encountered during the interventions will be noted in a logbook.
Benefits: This is a priority research because its aim is to develop a care system that is efficient and accessible for a target population. The results of this study will confirm the possibility to put in place a telerehabilitation program who could reach, on a larger scale, more patients suffering from Parkinson's disease.
- Conditions
- Parkinson Disease
- Being tested
- Rehabilitation intervention
- Keywords
- Tai Chi, Telerehabilitation, 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.
Rehabilitation interventionOther
Also called Télérehabilitation (Tai Chi)
Rehabilitation sessions based on Tai Chi through telerehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | Tai Chi intervention by telerehabilitation (3-month intervention, three sessions per week: two supervised session and one unsupervised session). Receives: Other: Rehabilitation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in balance
Mini BESTest
Measured: 3 months
Secondary outcomes (2)
Change in quality of life
PDQ-39 (Parkinson Disease Questionnaire - 39)This questionnaire assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living.Percentage score ranging between 0 and 100 (100%: more health problems).
Measured: 3 months
Satisfaction with service received
Satisfaction with health care services received (questionnaire, total score on 100%, 0% not satisfied at all with service received, 100%: very satisfied) )
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start22 Jan 2020
- Primary completion6 Jun 2020
- Study completion6 Jun 2020
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 Université de SherbrookeThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group receiving the intevention, one evaluation before and 1 one after the intervention period.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Tousignant, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985631
- Sponsor's protocol ID
- 2020-3253
- Acronym
- TeleParkinson
- Status last verified
- Sep 2021
- First submitted
- 23 May 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi Intervention by Telerehabilitation as an Innovative Solution for Parkinson's Disease Population
- ClinicalTrials.gov ID
- NCT03985631
- Acronym / sponsor ID
- TeleParkinson / 2020-3253
- Conditions
- Parkinson Disease
- Keywords
- Tai Chi, Telerehabilitation, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 6 Jun 2020 (actual)
- Study completion
- 6 Jun 2020 (actual)
- First posted
- 14 Jun 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.
Rational : A lot of people in the province of Quebec suffer from Parkinson's disease and they are mostly vulnerable because they gradually lose their autonomy with the worsening of the disease. Physiotherapy was proven to be an effective treatment method for these patients. However, accessibility to care remains a major issue.
Objective: This project aims to establish the clinical feasibility of a Tai chi rehabilitation program through tele rehabilitation to patients suffering of Parkinson's disease.
Methodology : This pilot study will be conduct with a pre/post-test device. Therefore, to reach the objective, an evaluation will be done before the intervention and directly after the end of the 12 weeks program. Also, the obstacles encountered during the interventions will be noted in a logbook.
Benefits: This is a priority research because its aim is to develop a care system that is efficient and accessible for a target population. The results of this study will confirm the possibility to put in place a telerehabilitation program who could reach, on a larger scale, more patients suffering from Parkinson's disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group receiving the intevention, one evaluation before and 1 one after the intervention period.
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Other: Rehabilitation interventionTai Chi intervention by telerehabilitation (3-month intervention, three sessions per week: two supervised session and one unsupervised session). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- to be diagnosed with Parkinson Disease according to the " Movement Disorders Society's diagnostic criteria " for at least 3 years
- Presence of a postural instability measured by the pull test according to Movement Disorders Society-Sponsored revision scale of Unified Parkinson Disease Rating scale " (MDS-UPDRS) with a score to item 3, 12 ≥ 1,
- Have access to Internet
- Have a caregiver available during rehabilitation sessions
Key exclusion criteria (1 listed)
- Have a une cognitive impairment measured by the " Mini-Mental State Examination " (MMSE), with a total score < 24.
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 |
|---|---|---|
| Rehabilitation interventionAlso: Télérehabilitation (Tai Chi)Rehabilitation sessions based on Tai Chi through telerehabilitation | Other | Telerehabilitation |
Primary outcome
Change in balance
Time frame: 3 months
Mini BESTest
2 secondary outcomes
Change in quality of life
Time frame: 3 months
Satisfaction with service received
Time frame: 3 months
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 29 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Michel Tousignant, PhD principal investigator
Université de Sherbrooke
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation intervention in people with Parkinson Disease, run by Université de Sherbrooke at 2 sites in Canada.
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 4 inclusion and 1 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 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Change in balance (time frame: 3 months). 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 29 Sep 2021.