Clinical trial NCT06052280: Pilot Study: Parkinson's Conventional Physiotherapy vs Home-based Telerehabilitation
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Telerehabilitation
Physical Activity
Physical Therapy Modalities
Lead sponsor: Azienda Sanitaria Locale CN1 Cuneo
Sponsor class: OTHER_GOV
First posted: 2023-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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:

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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Study recruitment potentials
timeFrame: baseline
measure: Single arm recruitment potentials
timeFrame: baseline
measure: Adherence to study path
timeFrame: 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)
measure: Compliance to interventions
timeFrame: 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:
measure: Cognitive functions
timeFrame: from baseline to follow-ups (at 6 months and at 12 months from baseline)
measure: Freezing of gait
timeFrame: from baseline to follow-ups (at 6 months and at 12 months from baseline)
measure: Movement disorders
timeFrame: from baseline to follow-ups (at 6 months and at 12 months from baseline)
measure: Postural control
timeFrame: from baseline to follow-ups (at 6 months and at 12 months from baseline)
measure: Sensory orientation
timeFrame: from baseline to follow-ups (at 6 months and at 12 months from baseline)
measure: Quality of life perception
timeFrame: from baseline to follow-ups (at 6 months and at 12 months from baseline)
measure: Walking ability
timeFrame: 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)
measure: Transition ability between sitting and standing
timeFrame: 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)
measure: Backward walking ability
timeFrame: 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)
measure: Turning ability
timeFrame: 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)
measure: Manual dexterity
timeFrame: 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)
measure: Transition ability between standing and prone position
timeFrame: 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)
measure: Dynamic stability
timeFrame: 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)
Other outcomes:
Locations:
city: Cuneo
country: Italy
facility: Azienda Sanitaria Locale CN1
Study officials:
affiliation: Neurology Unit, Movement Disorders Clinic , Local Health Authority, ASL Cuneo 1, Italy
name: Elona Brahimi, MD
role: PRINCIPAL_INVESTIGATOR
References: