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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Improvement in physical performance [Срок оценки: at baseline and 12 weeks later]

Вторичные конечные точки (2)

• Symptoms of Parkinson's disease progression [Срок оценки: at baseline and 12 weeks later]
• Improvement in lower limb function [Срок оценки: at baseline and 12 weeks later]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Италия · 1 центр

• IRCCS INRCA Hospital — Ancona

Идентификаторы

NCT: NCT06984393 · INRCA_007_2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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