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Evaluation of the Uses of a Digital-assisted Self-rehabilitation Device (TELE-PARK) (TELE-PARK)

Primary Purpose

Parkinson Disease, Parkinson's Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Self-rehabilitation by digital support
Sponsored by
Pôle Saint Hélier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson, Serious Game, Self management, Rehabilitation, Telemedicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients:

  • Men and women over the age of 18
  • With Parkinson's syndrome due to idiopathic Parkinson's disease or related syndromes
  • Presenting a complaint about balance and/or walking
  • With possible walking over a perimeter of at least 100 meters with or without technical aid
  • Hoehn and Yahr scale < or = to 4
  • Formulating their free and informed consent in writing.

Health professionals:

- physiotherapists and physiatrists hospital or voluntary volunteers practicing in the territory of health 5 in Brittany agreeing to participate in the study

Exclusion Criteria:

  • Orthopedic and rheumatologic pathologies that may prevent the achievement of measures
  • Comprehension disorders preventing the implementation of the protocol

Sites / Locations

  • Pôle Saint Hélier

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Self-rehabilitation by digital support

Arm Description

Provision to patients selected by doctors or physiotherapists of an interactive digital tool (tablet + inertial sensor) to support self-rehabilitation home Parkinson's patients. Monitoring and regulation of remote self-reeducation by tele-reeducation. Evaluation of the acceptance of the tool and the quality of life of the patients by questionnaire at day 0, and two and twelve months after.

Outcomes

Primary Outcome Measures

UTAUT Questionnaire
Questionnaire of acceptability / acceptance of the tool and its use by professionals based on the Unified Theory of Acceptance and Use Technology (UTAUT).

Secondary Outcome Measures

UTAUT Questionnaire
Questionnaires for integrating the tool and its use at 12 months for professionals and patients / entourage
Observance
Observance of self-rehabilitation using tablet data at 2 months and 12 months: the tablet records the number of sessions performed, their duration, the number and type of exercises performed
SF36
The 36-Item Short Form Health Survey is assessing the subjective quality of life of patients summarized in two component summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) scores. The SF-36 includes one multi-item scale that assesses eight health concepts. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table. The scores from those questions that address each specific area of functional health status are then averaged together, for a final score within each of the 8 dimensions measured. Reliability is measured by Cronbach's alpha coefficient. Its value is less than or equal to 1. It is considered "acceptable" from 0.7.
Rosenberg SES
Rosenberg's self-esteem scale (SES) assesses self-esteem. The questionnaire consists of 10 items of which 5 evaluate positive self-esteem and 5 negative self-esteem. The answer varies according to a four-point Likert-type scale from "Strongly disagree" (1) to "Totally agree" (4). A score between 10 and 40 is obtained. A score below 25 means very low self-esteem; a score between 25 and 31 means low self-esteem; a score between 31 and 34 means an average self-esteem; a score between 34 and 39 means a strong self-esteem; a score above 39 means a very strong self-esteem.
Zarit's Score
The Zarit scale assesses the emotional, physical and financial burden for caregivers of caring for someone with a loss of autonomy. The 22-item grid allows an assessment of this burden, ranging from mild to moderate to severe. The total score (sum of the 22-item scores) ranges from 0 to 88. A score less than or equal to 20 indicates a low or no burden; a score between 21 and 40 indicates a light burden; a score between 41 and 60 indicates a moderate burden; a score above 60 indicates a severe burden
Performance indicators
Alternatives that would have been implemented to meet the difficulties of the liberal therapist with his patient, number of kilometers saved by telereducation
VAS Satisfaction
The Visual Analogue Scale (VAS) allows a quick estimate of the level of satisfaction of patients by positioning themselves on a line whose extremities indicate the lowest level on the left (0) and the strongest on the right (10)

Full Information

First Posted
August 17, 2018
Last Updated
July 24, 2020
Sponsor
Pôle Saint Hélier
Collaborators
Réseau Parkinson Bretagne, Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03667456
Brief Title
Evaluation of the Uses of a Digital-assisted Self-rehabilitation Device (TELE-PARK)
Acronym
TELE-PARK
Official Title
Evaluation of the Uses of a Digital-assisted Self-rehabilitation Device Coupled With a Tele-reeducative Follow-up in Patients With Parkinson's Disease on a Defined Health Area (TELE-PARK)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
June 17, 2020 (Actual)
Study Completion Date
June 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pôle Saint Hélier
Collaborators
Réseau Parkinson Bretagne, Rennes University Hospital

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
Evaluate the use by the patient and his family and professional environment of a self-rehabilitation device with follow-up in tele-rehabilitation in people with Parkinson's disease taking into account the different actors within a health area (health professionals and paramedics in structure and in liberal).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Parkinson's Syndrome
Keywords
Parkinson, Serious Game, Self management, Rehabilitation, Telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-rehabilitation by digital support
Arm Type
Experimental
Arm Description
Provision to patients selected by doctors or physiotherapists of an interactive digital tool (tablet + inertial sensor) to support self-rehabilitation home Parkinson's patients. Monitoring and regulation of remote self-reeducation by tele-reeducation. Evaluation of the acceptance of the tool and the quality of life of the patients by questionnaire at day 0, and two and twelve months after.
Intervention Type
Procedure
Intervention Name(s)
Self-rehabilitation by digital support
Intervention Description
Provision to patients selected by doctors or physiotherapists of an interactive digital tool (tablet + inertial sensor) to support self-rehabilitation home Parkinson's patients.
Primary Outcome Measure Information:
Title
UTAUT Questionnaire
Description
Questionnaire of acceptability / acceptance of the tool and its use by professionals based on the Unified Theory of Acceptance and Use Technology (UTAUT).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
UTAUT Questionnaire
Description
Questionnaires for integrating the tool and its use at 12 months for professionals and patients / entourage
Time Frame
12 months
Title
Observance
Description
Observance of self-rehabilitation using tablet data at 2 months and 12 months: the tablet records the number of sessions performed, their duration, the number and type of exercises performed
Time Frame
12 months
Title
SF36
Description
The 36-Item Short Form Health Survey is assessing the subjective quality of life of patients summarized in two component summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) scores. The SF-36 includes one multi-item scale that assesses eight health concepts. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table. The scores from those questions that address each specific area of functional health status are then averaged together, for a final score within each of the 8 dimensions measured. Reliability is measured by Cronbach's alpha coefficient. Its value is less than or equal to 1. It is considered "acceptable" from 0.7.
Time Frame
12 months
Title
Rosenberg SES
Description
Rosenberg's self-esteem scale (SES) assesses self-esteem. The questionnaire consists of 10 items of which 5 evaluate positive self-esteem and 5 negative self-esteem. The answer varies according to a four-point Likert-type scale from "Strongly disagree" (1) to "Totally agree" (4). A score between 10 and 40 is obtained. A score below 25 means very low self-esteem; a score between 25 and 31 means low self-esteem; a score between 31 and 34 means an average self-esteem; a score between 34 and 39 means a strong self-esteem; a score above 39 means a very strong self-esteem.
Time Frame
12 months
Title
Zarit's Score
Description
The Zarit scale assesses the emotional, physical and financial burden for caregivers of caring for someone with a loss of autonomy. The 22-item grid allows an assessment of this burden, ranging from mild to moderate to severe. The total score (sum of the 22-item scores) ranges from 0 to 88. A score less than or equal to 20 indicates a low or no burden; a score between 21 and 40 indicates a light burden; a score between 41 and 60 indicates a moderate burden; a score above 60 indicates a severe burden
Time Frame
12 months
Title
Performance indicators
Description
Alternatives that would have been implemented to meet the difficulties of the liberal therapist with his patient, number of kilometers saved by telereducation
Time Frame
12 months
Title
VAS Satisfaction
Description
The Visual Analogue Scale (VAS) allows a quick estimate of the level of satisfaction of patients by positioning themselves on a line whose extremities indicate the lowest level on the left (0) and the strongest on the right (10)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients: Men and women over the age of 18 With Parkinson's syndrome due to idiopathic Parkinson's disease or related syndromes Presenting a complaint about balance and/or walking With possible walking over a perimeter of at least 100 meters with or without technical aid Hoehn and Yahr scale < or = to 4 Formulating their free and informed consent in writing. Health professionals: - physiotherapists and physiatrists hospital or voluntary volunteers practicing in the territory of health 5 in Brittany agreeing to participate in the study Exclusion Criteria: Orthopedic and rheumatologic pathologies that may prevent the achievement of measures Comprehension disorders preventing the implementation of the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Gallien, Doctor
Organizational Affiliation
Pole Saint Hélier
Official's Role
Study Director
Facility Information:
Facility Name
Pôle Saint Hélier
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Uses of a Digital-assisted Self-rehabilitation Device (TELE-PARK)

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