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

NCT ID: NCT06984393

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-02

Study Completion Date

2026-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease Older People

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention arm

Older peple with Parkinson disease

Group Type EXPERIMENTAL

home tele-rehabilitation

Intervention Type OTHER

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

Older peple with Parkinson disease

Group Type SHAM_COMPARATOR

Usual care

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministry of Health, Italy

OTHER_GOV

Sponsor Role collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roberta Bevilacqua, PhD

Role: STUDY_DIRECTOR

IRCCS INRCA, Ancona, Italy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IRCCS INRCA Hospital

Ancona, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anna Rita Bonfigli

Role: CONTACT

0718003719

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Elvira Maranesi

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

INRCA_007_2024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.