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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
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.
Azienda Sanitaria Locale CN1
Cuneo, Italy
RECRUITINGStudy recruitment potentials
total number of enrolled subjects / total number of eligible subjects
Time frame: baseline
Single arm recruitment potentials
arm-specific number of enrolled subjects / arm-specific number of eligible subjects
Time frame: baseline
Adherence to study path
drop-out rate at each single step, total and by arm
Time frame: 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
Time frame: 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)
Cognitive functions
Possible patients' changes in Montreal Cognitive Assessment. This scale ranges from 0 to 30 points, with higher scores meaning a better outcome.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: from baseline to follow-ups (at 6 months and at 12 months from baseline)
Quality of life perception
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
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