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

Not Applicable

Not yet recruiting

• Conditions: Parkinson Disease; Older People

• Registration Number: NCT06984393
• Lead Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani

Brief 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.

Detailed Description

The DHEAL-COM-PD project aims to evaluate the improvement in physical performance of Parkinson's disease patients following an integrated rehabilitation intervention with technology in telerehabilitation. In fact, the project involves the administration of a rehabilitation intervention in telerehabilitation integrated with BTS TELEREHAB technology, which is able to recognize the patient's movements and analyze them according to quantitative (repetitions) and qualitative (postural and balance)-indicators.

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Study Start: 2025-09-02
• Primary Completion: 2026-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Symptoms of Parkinson's disease progression	at baseline and 12 weeks later	The Symptoms of Parkinson's disease will be evaluated by the Hoen \& Yahr Scale. The stages of the scale are: 1 - Unilateral involvement only; 1.5 - Unilateral and axial involvement; 2 - Bilateral involvement without impairment of balance; 2.5 - Mild bilateral involvement without recovery on the pull test; 3 - Mild to moderate bilateral involvement; postural instability; physically self-sufficient; 4 - Severe disability; still able to walk or stand without assistance; 5 - Bedridden or wheelchair-bound.
Improvement in lower limb function	at baseline and 12 weeks later	It will be measured by the Short Physical Performance Battery (SPPB). The total scale score has a range from 0 to 12, with 12 indicating the maximum performance.

Trial Locations

Locations (1)

IRCCS INRCA Hospital; 🇮🇹 Ancona, Italy