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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorIstituto Nazionale di Ricovero e Cura per Anziani

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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";

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • home tele-rehabilitation

    Other intervention

    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

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intervention armExperimental treatment 1 intervention
Group B: Usual careSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Improvement in physical performance

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.

Time frame
at baseline and 12 weeks later

Secondary outcomes

1

Symptoms of Parkinson's disease progression

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.

Time frame
at baseline and 12 weeks later
2

Improvement in lower limb function

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.

Time frame
at baseline and 12 weeks later

Other outcomes

Sponsors and contacts

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