Pilot Study: Parkinson's Conventional Physiotherapy vs Home-based Telerehabilitation

NCT ID: NCT06052280

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-09
• Study Completion Date: 2025-10-31

Brief Summary

The Parkinson TELEREHABilitation-NET pilot study (Parkinson TELEREHAB-NET) is designed to observe and monitor PD patients in their initial phase (which includes the period from the onset of motor symptoms until the onset of motor fluctuations) and to assess the feasibility of an integrated multidimensional approach in treating and managing PD patients in a local clinical setting (ASL CN1). Chiefly, through this pilot study, feasibility and acceptability of the general experimental plan, as well as the potential for positive effects of physiotherapy in early PD patients will be assessed.

So, this pilot study primarily aims at:

1. validating the feasibility of the study protocol, assessing participants' inclusion and exclusion criteria, testing instruments/procedures used for home rehabilitation (both for the Telerehabilitation Exercise group - TrE arm and for the Home Self-Exercise group - HSE arm), testing the suitability of the method for data collection;

2. obtaining the required preliminary data for the calculation of a sample size for the primary outcome, in both arms;

3. evaluating appropriateness of the consent form, recruitment potentials, time needed to receive written consent, and the required number of researchers/medical specialists/physiotherapists needed to cover the whole study path;

4. assessing patients' acceptability of the intervention, through the evaluation of the adherence to rehabilitation process (in both arms), the completeness of proposed measurements, and compliance at follow-up.

Secondary objectives are the monitoring of patients' perceived quality of life, and of motor performance and non-motor symptoms through specific rating scales, after completing the whole rehabilitation path (described below) compared to baseline level, and maintenance of results over time.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telerehabilitation Exercise group (TrE arm)

Group Type: EXPERIMENTAL

Telerehabilitation exercise program

Intervention Type: OTHER

After the outpatient intensive physical therapy program (common to both study arms), patients in the TrE group will continue with prescribed self-training at home through telerehabilitation, at least 3 times a week for 4 weeks. Each physical exercise session will consist of at least 5 minutes of aerobic warming-up, 35 minutes of specific high-intensity exercises for PD, and 5 minutes of aerobic cool-down.

The TrE arm will be supported by a telerehabilitation device which will be installed and tested at the patients' home immediately after the outpatient intensive program. The device will track any access and exercise duration, so that the physiotherapists will be able to remotely monitor both the actual duration of each session and their weekly frequency. One session per week will be directly and online supervised by a physiotherapist, while the other two will be recorded only.

Home Self-Exercise group (HSE arm)

Group Type: ACTIVE_COMPARATOR

Home self-exercise program

Intervention Type: OTHER

After the outpatient intensive physical therapy program (common to both study arms), patients in the HSE group will continue with prescribed self-training at home, at least 3 times a week for 4 weeks. Each physical exercise session will consist of at least 5 minutes of aerobic warming-up, 35 minutes of specific high-intensity exercises for PD, and 5 minutes of aerobic cool-down.

The HSE arm will be given a booklet containing detailed explanations and pictures of the assigned exercises, in order to guide them in the correct execution of the requested movements. Subjects in this group will be asked to fill in a training diary to keep track of the training sessions and their duration. Once a week a physiotherapist will contact patients to discuss possible problems encountered in performing the exercises and to help in solving them.

Interventions

Telerehabilitation exercise program

After the outpatient intensive physical therapy program (common to both study arms), patients in the TrE group will continue with prescribed self-training at home through telerehabilitation, at least 3 times a week for 4 weeks. Each physical exercise session will consist of at least 5 minutes of aerobic warming-up, 35 minutes of specific high-intensity exercises for PD, and 5 minutes of aerobic cool-down.

The TrE arm will be supported by a telerehabilitation device which will be installed and tested at the patients' home immediately after the outpatient intensive program. The device will track any access and exercise duration, so that the physiotherapists will be able to remotely monitor both the actual duration of each session and their weekly frequency. One session per week will be directly and online supervised by a physiotherapist, while the other two will be recorded only.

Intervention Type: OTHER

Home self-exercise program

After the outpatient intensive physical therapy program (common to both study arms), patients in the HSE group will continue with prescribed self-training at home, at least 3 times a week for 4 weeks. Each physical exercise session will consist of at least 5 minutes of aerobic warming-up, 35 minutes of specific high-intensity exercises for PD, and 5 minutes of aerobic cool-down.

The HSE arm will be given a booklet containing detailed explanations and pictures of the assigned exercises, in order to guide them in the correct execution of the requested movements. Subjects in this group will be asked to fill in a training diary to keep track of the training sessions and their duration. Once a week a physiotherapist will contact patients to discuss possible problems encountered in performing the exercises and to help in solving them.

Intervention Type: OTHER

Other Intervention Names

Virtual self-exercise program; Conventional self-exercise program

Eligibility Criteria

Inclusion Criteria

General:

• adults, aged 18 or older;
• medical diagnosis of idiopathic PD according the most recent Movement Disorder Society diagnostic criteria;
• disease stage ≤ 2 on the Hoehn&Yahr scale;
• Montreal Cognitive Assessment score >25;
• ability to read, understand and provide a written informed consent, in accordance with good clinical practice and local regulations;
• motivation and possibility to show up for planned controls and to comply with the requested study procedures.

Specific for TrE arm:

• wireless internet access at home;
• adequate room to place telerehabilitation device (about 2 meters in front of device monitor).

Exclusion Criteria

• <18 years of age;
• Any atypical, iatrogenic, or secondary Parkinsonism;
• Disease stage > 2 on the Hoehn&Yahr scale;
• Any severe orthopaedic, vascular, respiratory, or cardiac problems or any other medical condition that, in the principal investigator's opinion, could limit participation in moderate exercise or the study protocol.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Sanitaria Locale CN1 Cuneo

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elona Brahimi, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology Unit, Movement Disorders Clinic , Local Health Authority, ASL Cuneo 1, Italy

Locations

Azienda Sanitaria Locale CN1

Cuneo, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Federica Gallo, Biostatistic

Role: CONTACT

federica.gallo@aslcn1.it

+390174676121

Facility Contacts

Federica Gallo, Biostatistic

Role: primary

federica.gallo@aslcn1.it

0172699235

Elona Bahimi, Neurologist

Role: backup

elona.brahimi@aslcn1.it

0174676121

Other Identifiers

Resolution 982 of May 16, 2023

Identifier Type: -

Identifier Source: org_study_id