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

Study Overview
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Brief Summary
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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: 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; obtaining the required preliminary data for the calculation of a sample size for the primary outcome, in both arms; 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; 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.

Official Title
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Management of Initial Parkinson's Disease: a Prospective, Mono-centric, no Profit Pilot Clinical Trial Comparing Conventional Face-to-face Physiotherapy and Home-based Telerehabilitation

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Telerehabilitation exercise program
* Other: Home self-exercise program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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: assessing participants' inclusion/exclusion criteria, testing instruments/procedures, testing data collection method; obtaining preliminary data to estimate sample size for the primary outcome, in both arms; evaluating appropriateness of the consent form, recruitment potentials, and the required number of researchers needed for study management; 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telerehabilitation Exercise group (TrE arm)<br> | Other: Telerehabilitation exercise program<br>* 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.<br>* Other names: Virtual self-exercise program;|
| Active Comparator: Home Self-Exercise group (HSE arm)<br> | Other: Home self-exercise program<br>* 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.<br>* Other names: Conventional self-exercise program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive functions | Possible patients' changes in Montreal Cognitive Assessment. This scale ranges from 0 to 30 points, with higher scores meaning a better outcome. | from baseline to follow-ups (at 6 months and at 12 months from baseline) | 
| Freezing of gait | Possible patients' changes in Freezing of Gait Questionnaire. This scale ranges from 0 to 24 points, with higher scores meaning a worse outcome. | from baseline to follow-ups (at 6 months and at 12 months from baseline) | 
| Movement disorders | Possible patients' changes in Movement Disorder Scale (parts 1, 2, 3, and 4). This scale ranges from 0 to 260 points, with higher scores meaning a worse outcome. | from baseline to follow-ups (at 6 months and at 12 months from baseline) | 
| Postural control | Possible patients' changes in Mini-Balance Evaluation System Test. This scale ranges from 0 to 28 points, with higher scores meaning a better outcome. | from baseline to follow-ups (at 6 months and at 12 months from baseline) | 
| Sensory orientation | Possible patients' changes in Non-Motor Symptom Scale. This scale ranges from 0 to 360 points, with higher scores meaning a worse outcome. | from baseline to follow-ups (at 6 months and at 12 months from baseline) | 
| Quality of life | Possible patients' changes in Parkinson's Disease Quality of Life Questionnaire. This scale ranges from 0 to 32 points, with higher scores meaning a worse outcome. | from baseline to follow-ups (at 6 months and at 12 months from baseline) | 
| Walking ability | Possible patients' changes in 6-minute walking test. This test measures how many meters the patient can cover in 6 minutes. The minimum is 0 meter, the maximum is not pre-specified; a longer distance means a better outcome. | after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline) | 
| Transition ability between sitting and standing | Possible patients' changes in 5-time sit-to-stand test. This test measures in how many seconds the patient manages to sit and stand for 5 times. Minimum and maximum time lengths are not pre-specified; a higher time means a worse outcome. | after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline) | 
| Backward walking ability | Possible patients' changes in 3-meter backward walking test. This test measures in how many seconds the patient manages to walk backward for a 3 meters distance. Minimum and maximum time lengths are not pre-specified; a higher time means a worse outcome. | after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline) | 
| Turning ability | Possible patients' changes in 360° turn right-to-left test. This test measures in how many seconds the patient manages to perform a complete 360° turn from right to left. Minimum and maximum time lengths are not pre-specified; a higher time means a worse outcome. | after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline) | 
| Manual dexterity | Possible patients' changes in Coin rotation test. This test measures how many times the patient manages to turn a coin (of 25 millimeters in diameter) in 30 seconds. The minimum is 0, the maximum is not pre-specified; more the times better the outcome. | after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline) | 
| Transition ability between standing and prone position | Possible patients' changes in Stand-prone-stand test. This test measures in how many seconds the patient takes to change position from standing to prone to standing again. Minimum and maximum time lengths are not pre-specified; a higher time means a worse outcome. | after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline) | 
| Dynamic stability | Possible patients' changes in 4-square-step test. This test measures in how many seconds the patient sequentially steps over four delimited areas (1 square meter large). Minimum and maximum time lengths are not pre-specified; a higher time means a worse outcome. | after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Telerehabilitation, Physical Activity, Physical Therapy Modalities