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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Not yet enrolling

Conditions: Older People; Parkinson Disease

Treatments: Other: Usual care; Other: home tele-rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06984393

INRCA_007_2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Intervention arm

Experimental group

Description:

Older peple with Parkinson disease

Treatment:

Other: home tele-rehabilitation

Usual care

Sham Comparator group

Description:

Older peple with Parkinson disease

Treatment:

Other: Usual care