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Starting soon Not applicable

Tele-Rehabilitation Intervention in Community-Based Healthcare for Patients With Parkinson's Disease (DHEAL-COM-PD)

NCT06984393 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-09-02
Last updated
2025-05-22

Condition(s) studied

Parkinson DiseaseOlder People

Investigational drug(s) / intervention(s)

home tele-rehabilitationUsual care

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.

Study summary

The study aims to measure the improvement in functional capacity in a group of elderly people suffering from early-stage Parkinson's disease (Hoehn \& Yahr scale 1-3), following a telerehabilitation intervention integrated with BTS TELEREHAB technology.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Suffering from Parkinson's disease: Hoehn \& Yahr stage I-III; * 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: * Myocardial infarction or stroke within 6 months; * 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.

Primary outcome measure(s)

  • Improvement in physical performance — at baseline and 12 weeks later
    Physical performance will be evaluated by the Performance-Oriented Mobility Assessment (POMA) test. The total POMA (POMA-T) consists of two sub-scales: the balance rating scale ("balance scale" or POMA-B) and the gait rating scale ("gait scale" or POMA-G). The POMA-B assesses the subject through postures and changes in position that reflect stability patterns related to activities of daily living. In the POMA-G, qualitative aspects of locomotion are considered instead. Each item is scored based on a two- or three-point scale, with a maximum score (POMA-T), derived from the sum of the two sub-scales, of 28 points: in detail, the maximum score for POMA-B is 16, while for POMA-G the maximum score is 12.

Trial sites (1)

FacilityCityRegionStatus
IRCCS INRCA Hospital Ancona Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06984393 on ClinicalTrials.gov ↗ ← All trials in Italy