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

NCT06052280 | Recruiting

• 1 other identifier: Resolution 982 of May 16, 2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 2.obtaining the required preliminary data for the calculation of a sample size for the primary outcome, in both arms;
3. 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. 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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Telerehabilitation; Physical Activity; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (4)

• Study recruitment potentials

  total number of enrolled subjects / total number of eligible subjects

  baseline

• Single arm recruitment potentials

  arm-specific number of enrolled subjects / arm-specific number of eligible subjects

  baseline

• Adherence to study path

  drop-out rate at each single step, total and by arm

  at end of outpatient intensive exercise program (4 weeks from baseline), after training at home (8 weeks from baseline), and for home-based training (follow-ups at 6 months and at 12 months from baseline)

• Compliance to interventions

  number of fulfilled visits / number of scheduled visits

  at end of outpatient intensive exercise program (4 weeks from baseline), after training at home (8 weeks from baseline), and for home-based training (follow-ups at 6 months and at 12 months from baseline)

Secondary Outcomes (13)

• Cognitive functions

  from baseline to follow-ups (at 6 months and at 12 months from baseline)

• Freezing of gait

  from baseline to follow-ups (at 6 months and at 12 months from baseline)

• Movement disorders

  from baseline to follow-ups (at 6 months and at 12 months from baseline)

• Postural control

  from baseline to follow-ups (at 6 months and at 12 months from baseline)

• Sensory orientation

  from baseline to follow-ups (at 6 months and at 12 months from baseline)

Study Arms (2)

Telerehabilitation Exercise group (TrE arm)

EXPERIMENTAL

Other: Telerehabilitation exercise program

Home Self-Exercise group (HSE arm)

ACTIVE COMPARATOR

Other: Home self-exercise program

Interventions

Telerehabilitation exercise program 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.

Also known as: Virtual self-exercise program

Telerehabilitation Exercise group (TrE arm)

Home self-exercise program 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.

Also known as: Conventional self-exercise program

Home Self-Exercise group (HSE arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Azienda Sanitaria Locale CN1 Cuneo: lead

Study Sites (1)

Azienda Sanitaria Locale CN1

Cuneo, 12030, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Elona Brahimi, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federica Gallo, Biostatistic

CONTACT

+390174676121; federica.gallo@aslcn1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This pilot study is designed to assess the feasibility of the integrated multidimensional approach in treating and rehabilitating PD patients in a local clinical setting, both for the Telerehabilitation Exercise (TrE) arm and for the Home Self-Exercise (HSE) arm, by: 1. assessing participants' inclusion/exclusion criteria, testing instruments/procedures, testing data collection method; 2. obtaining preliminary data to estimate sample size for the primary outcome, in both arms; 3. evaluating appropriateness of the consent form, recruitment potentials, and the required number of researchers needed for study management; 4. assessing patients' acceptability of the intervention and their compliance. Secondary objectives are the monitoring of patients' perceived quality of life, and of motor performance and non-motor symptoms through specific rating scales.

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 25, 2023
• Study Start: October 9, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)