Parkinson DiseaseTELE-PARKNCT03667456
Evaluation of the Uses of a Digital-assisted Self-rehabilitation Device (TELE-PARK)
A study testing Self-rehabilitation by digital support in people with Parkinson Disease and Parkinson's Syndrome, run by Pôle Saint Hélier at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Parkinson's Syndrome
- What is being tested?
- Self-rehabilitation by digital support
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2018to 26 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
- 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
Show all 9Show fewer
- 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
Who cannot join
- Orthopedic and rheumatologic pathologies that may prevent the achievement of measures
- Comprehension disorders preventing the implementation of the protocol
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- Self-rehabilitation by digital support
- Keywords
- Parkinson, Serious Game, Self management, Rehabilitation, Telemedicine
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-rehabilitation by digital supportProcedure or surgery
Provision to patients selected by doctors or physiotherapists of an interactive digital tool (tablet + inertial sensor) to support self-rehabilitation home Parkinson's patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Self-rehabilitation by digital support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (7)
UTAUT Questionnaire
Questionnaires for integrating the tool and its use at 12 months for professionals and patients / entourage
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start11 Jun 2018
- Primary completion17 Jun 2020
- Study completion26 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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pôle Saint Hélier
- Sponsor type
- University, hospital or other
- Collaborators
- Réseau Parkinson Bretagne, Rennes University Hospital
- Responsible party
- Sponsor
- Investigators
- Philippe Gallien, Doctor, Study director, Pole Saint Hélier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667456
- Sponsor's protocol ID
- 2017-A02379-44
- Acronym
- TELE-PARK
- Status last verified
- Nov 2019
- First submitted
- 17 Aug 2018
- Last updated
- 27 Jul 2020
- 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 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03667456
- Acronym / sponsor ID
- TELE-PARK / 2017-A02379-44
- Conditions
- Parkinson Disease, Parkinson's Syndrome
- Keywords
- Parkinson, Serious Game, Self management, Rehabilitation, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Collaborators
- Réseau Parkinson Bretagne, Rennes University Hospital
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 12 Sep 2018 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-rehabilitation by digital support | Experimental | Procedure: Self-rehabilitation by digital supportProvision 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Orthopedic and rheumatologic pathologies that may prevent the achievement of measures
- Comprehension disorders preventing the implementation of the protocol
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 |
|---|---|---|
| Self-rehabilitation by digital supportProvision to patients selected by doctors or physiotherapists of an interactive digital tool (tablet + inertial sensor) to support self-rehabilitation home Parkinson's patients. | Procedure or surgery | Self-rehabilitation by digital support |
Primary outcome
UTAUT Questionnaire
Time frame: 12 months
Questionnaire of acceptability / acceptance of the tool and its use by professionals based on the Unified Theory of Acceptance and Use Technology (UTAUT).
7 secondary outcomes
UTAUT Questionnaire
Time frame: 12 months
Observance
Time frame: 12 months
SF36
Time frame: 12 months
Rosenberg SES
Time frame: 12 months
Zarit's Score
Time frame: 12 months
Performance indicators
Time frame: 12 months
VAS Satisfaction
Time frame: 12 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 27 Jul 2020.
- 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.
Philippe Gallien, Doctor study director
Pole Saint Hélier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-rehabilitation by digital support in people with Parkinson Disease and Parkinson's Syndrome, run by Pôle Saint Hélier at 1 site in France.
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 9 inclusion and 2 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 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
UTAUT Questionnaire (time frame: 12 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 27 Jul 2020.