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

NCT03667456 | Completed

• 1 other identifier: 2017-A02379-44
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson Disease; Parkinson's Syndrome

Keywords

Parkinson; Serious Game; Self management; Rehabilitation; Telemedicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• UTAUT Questionnaire

  12 months

• Observance

  12 months

• SF36

  12 months

• Rosenberg SES

  12 months

• Zarit's Score

  12 months

Study Arms (1)

Self-rehabilitation by digital support

EXPERIMENTAL

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

Interventions

Self-rehabilitation by digital support PROCEDURE

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

Self-rehabilitation by digital support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pôle Saint Hélier: lead
• Réseau Parkinson Bretagne: collaborator
• Rennes University Hospital: collaborator

Study Sites (1)

Pôle Saint Hélier

Rennes, Brittany Region, 35000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Philippe Gallien, Doctor

  Pole Saint Hélier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: September 12, 2018
• Study Start: June 11, 2018
• Primary Completion: June 17, 2020
• Study Completion: June 26, 2020
• Last Updated: July 27, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)