Tele-Rehabilitation Intervention in Community-Based Healthcare for Patients With Parkinson's Disease (DHEAL-COM-PD)
NCT ID: NCT06984393
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-09-02
2026-05-30
Brief Summary
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Detailed Description
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The trial is a feasibility study, with single-blind randomized controlled trial type experimental design. Forty older adults with Parkinson's disease will be recruited for the study and randomized into two groups: the experimental group, that will perform tele-rehabilitation at home with a non-immersive virtual reality system, and the control group. Patients in the control group will be offered activities to perform at home, with the same frequency, in line with the usual care activities already proposed by the Rehabilitation Unit.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Intervention arm
Older peple with Parkinson disease
home tele-rehabilitation
Patients will receive a personalised home tele-rehabilitation exercise program consisting of 3 sessions per week for a duration of 12 weeks. The sessions will be organised as follows: one session will be conducted via tele-rehabilitation with the support of a physiotherapist in small groups of up to 5 patients; in the remaining two sessions, the patient will perform the exercises independently at home. BTS TELEREHAB is the platform that will allow the delivery of remote rehabilitation services. The patient is given the system to take home, where they will connect the small Brain PC, that is the computer unit of the BTS TELEREHAB solution, to their television. Before starting the rehabilitation program, the patient will receive training with the technology in the hospital, in the presence of the physiotherapist. During motor rehabilitation sessions, the patient wears a special inertial sensor, the G-Sensor device.
Usual care
Older peple with Parkinson disease
Usual care
Participants will receive a booklet containing information and activities on well-being. They will be invited to do whatever they wish with the information booklet and the proposed exercises.
Interventions
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home tele-rehabilitation
Patients will receive a personalised home tele-rehabilitation exercise program consisting of 3 sessions per week for a duration of 12 weeks. The sessions will be organised as follows: one session will be conducted via tele-rehabilitation with the support of a physiotherapist in small groups of up to 5 patients; in the remaining two sessions, the patient will perform the exercises independently at home. BTS TELEREHAB is the platform that will allow the delivery of remote rehabilitation services. The patient is given the system to take home, where they will connect the small Brain PC, that is the computer unit of the BTS TELEREHAB solution, to their television. Before starting the rehabilitation program, the patient will receive training with the technology in the hospital, in the presence of the physiotherapist. During motor rehabilitation sessions, the patient wears a special inertial sensor, the G-Sensor device.
Usual care
Participants will receive a booklet containing information and activities on well-being. They will be invited to do whatever they wish with the information booklet and the proposed exercises.
Eligibility Criteria
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Inclusion Criteria
* Functional Ambulation Category (FAC) score ≥ 3;
* Stability of drug treatment for at least 1 month;
* Maintaining an upright position independently \> 30";
* No acute or untreated health problems;
* Mini Mental State Examination (MMSE) ≥ 24;
* Geriatric Depression Score (GDS) \< 2;
Exclusion Criteria
* Painful arthritis, spinal stenosis, amputation, painful foot lesions, or neuropathy that limits balance and mobility;
* Uncontrolled hypertension
* Metastatic cancer or immunosuppressive therapy;
* Significant visual or hearing impairment.
65 Years
ALL
No
Sponsors
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Ministry of Health, Italy
OTHER_GOV
Istituto Nazionale di Ricovero e Cura per Anziani
OTHER
Responsible Party
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Principal Investigators
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Roberta Bevilacqua, PhD
Role: STUDY_DIRECTOR
IRCCS INRCA, Ancona, Italy
Locations
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IRCCS INRCA Hospital
Ancona, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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INRCA_007_2024
Identifier Type: -
Identifier Source: org_study_id
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