Parkinson DiseaseDHEAL-COM-PDNCT06984393
Tele-Rehabilitation Intervention in Community-Based Healthcare for Patients With Parkinson's Disease (DHEAL-COM-PD)
A study testing home tele-rehabilitation in people with Parkinson Disease and Older People, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Parkinson Disease, Older People
- What is being tested?
- home tele-rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 2 Sep 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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;
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS INRCA Hospital
Ancona, 60127
Elvira Maranesi, e.maranesi@inrca.it
Roberta Bevilacqua, PhD
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease, Older People
- Being tested
- home tele-rehabilitation, Usual care
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home tele-rehabilitationOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Older peple with Parkinson disease Receives: Other: home tele-rehabilitation |
| Usual care | Sham comparator | Older peple with Parkinson disease Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline and 12 weeks later
Secondary outcomes (2)
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.
Measured: at baseline and 12 weeks later
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.
Measured: at baseline and 12 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start2 Sep 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Sponsor
- Investigators
- Roberta Bevilacqua, PhD, Study director, IRCCS INRCA, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984393
- Sponsor's protocol ID
- INRCA_007_2024
- Acronym
- DHEAL-COM-PD
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-Rehabilitation Intervention in Community-Based Healthcare for Patients With Parkinson's Disease (DHEAL-COM-PD)
- ClinicalTrials.gov ID
- NCT06984393
- Acronym / sponsor ID
- DHEAL-COM-PD / INRCA_007_2024
- Conditions
- Parkinson Disease, Older People
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 2 Sep 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: home tele-rehabilitationOlder peple with Parkinson disease |
| Usual care | Sham comparator | Other: Usual careOlder peple with Parkinson disease |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home tele-rehabilitationPatients 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. | Other | Intervention arm |
| Usual careParticipants 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. | Other | Usual care |
Primary outcome
Improvement in physical performance
Time frame: at baseline and 12 weeks later
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberta Bevilacqua, PhD study director
IRCCS INRCA, Ancona, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home tele-rehabilitation in people with Parkinson Disease and Older People, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Rita Bonfigli (0718003719, a.bonfigli@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in physical performance (time frame: at baseline and 12 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.