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出境医 / 临床实验 / Tai Chi Intervention by Telerehabilitation (TeleParkinson)

Tai Chi Intervention by Telerehabilitation (TeleParkinson)

Study Description
Brief 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. 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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Rehabilitation intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group receiving the intevention, one evaluation before and 1 one after the intervention period.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Tai Chi Intervention by Telerehabilitation as an Innovative Solution for Parkinson's Disease Population
Actual Study Start Date : March 6, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Telerehabilitation
Tai Chi intervention by telerehabilitation (3-month intervention, three sessions per week: two supervised session and one unsupervised session).
Other: Rehabilitation intervention
Rehabilitation sessions based on Tai Chi through telerehabilitation
Other Name: Télérehabilitation (Tai Chi)

Outcome Measures
Primary Outcome Measures :
  1. Change in balance [ Time Frame: 3 months ]
    Mini BESTest


Secondary Outcome Measures :
  1. Change in quality of life [ Time Frame: 3 months ]
    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).

  2. Satisfaction with service received [ Time Frame: 3 months ]
    Satisfaction with health care services received (questionnaire, total score on 100%, 0% not satisfied at all with service received, 100%: very satisfied) )


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Have a une cognitive impairment measured by the " Mini-Mental State Examination " (MMSE), with a total score < 24.
Contacts and Locations

Contacts
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Contact: Catherine Pagé, MSc 819-780-2220 ext 45421 catherine.page@usherbrooke.ca

Locations
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Canada, Quebec
Université de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1K 2R1
Contact: Michel Tousignant, PhD         
Canada
Research Centre on Aging Recruiting
Sherbrooke, Canada
Contact: Catherine Pagé    819-780-2220 ext 45421    catherine.page@usherbrooke.ca   
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Layout table for investigator information
Principal Investigator: Michel Tousignant, PhD Université de Sherbrooke
Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE March 6, 2019
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
Change in balance [ Time Frame: 3 months ]
Mini BESTest
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • Change in quality of life [ Time Frame: 3 months ]
    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).
  • Satisfaction with service received [ Time Frame: 3 months ]
    Satisfaction with health care services received (questionnaire, total score on 100%, 0% not satisfied at all with service received, 100%: very satisfied) )
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tai Chi Intervention by Telerehabilitation
Official Title  ICMJE Tai Chi Intervention by Telerehabilitation as an Innovative Solution for Parkinson's Disease Population
Brief 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. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single group receiving the intevention, one evaluation before and 1 one after the intervention period.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Parkinson Disease
Intervention  ICMJE Other: Rehabilitation intervention
Rehabilitation sessions based on Tai Chi through telerehabilitation
Other Name: Télérehabilitation (Tai Chi)
Study Arms  ICMJE Experimental: Telerehabilitation
Tai Chi intervention by telerehabilitation (3-month intervention, three sessions per week: two supervised session and one unsupervised session).
Intervention: Other: Rehabilitation intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 12, 2019)
9
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Have a une cognitive impairment measured by the " Mini-Mental State Examination " (MMSE), with a total score < 24.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Catherine Pagé, MSc 819-780-2220 ext 45421 catherine.page@usherbrooke.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03985631
Other Study ID Numbers  ICMJE 2020-3253
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Université de Sherbrooke
Study Sponsor  ICMJE Université de Sherbrooke
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michel Tousignant, PhD Université de Sherbrooke
PRS Account Université de Sherbrooke
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP