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Not yet recruiting NCT06984393

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

No phase Interventional Parkinson Disease Older People

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: home tele-rehabilitation, Usual care.
Who it may be relevant to
Registry conditions: Parkinson Disease, Older People. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other 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.
  • Other 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.

Primary outcome measures

  • Improvement in physical performance [Time frame: at baseline and 12 weeks later]
Secondary outcome measures (2)
  • Symptoms of Parkinson's disease progression [Time frame: at baseline and 12 weeks later]
  • Improvement in lower limb function [Time frame: at baseline and 12 weeks later]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Italy · 1 center
  • IRCCS INRCA Hospital — Ancona

Identifiers

NCT: NCT06984393 · INRCA_007_2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗