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

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)

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).

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Parkinson's Syndrome
• Intervention / Treatment: Procedure: Self-rehabilitation by digital support

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bretagne
    • Rennes, Bretagne, France, 35000
      • Pôle Saint Hélier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Self-rehabilitation by digital support; 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.

Procedure: Self-rehabilitation by digital support; Provision to patients selected by doctors or physiotherapists of an interactive digital tool (tablet + inertial sensor) to support self-rehabilitation home Parkinson's patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UTAUT Questionnaire	Questionnaires for integrating the tool and its use at 12 months for professionals and patients / entourage	12 months
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	12 months
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.	12 months
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.	12 months
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	12 months
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	12 months
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)	12 months

Collaborators and Investigators

• Sponsor: Pôle Saint Hélier
• Collaborators: Rennes University Hospital; Réseau Parkinson Bretagne
• Investigators: Study Director: Philippe Gallien, Doctor, Pôle Saint Hélier

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2018
• Primary Completion (ACTUAL): June 17, 2020
• Study Completion (ACTUAL): June 26, 2020

Study Registration Dates

• First Submitted: August 17, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (ACTUAL): September 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Rehabilitation; Telemedicine; Parkinson; Self management; Serious Game
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2017-A02379-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No