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

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Other: Home self-exercise program; Other: Telerehabilitation exercise program

• Registration Number: NCT06052280
• Lead Sponsor: Azienda Sanitaria Locale CN1 Cuneo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-25
• Study Start: 2023-10-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2024-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home Self-Exercise group (HSE arm)	Home self-exercise program	-
Telerehabilitation Exercise group (TrE arm)	Telerehabilitation exercise program	-

Primary Outcome Measures

Name	Time	Method
Single arm recruitment potentials	baseline	arm-specific number of enrolled subjects / arm-specific number of eligible subjects
Compliance to interventions	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)	number of fulfilled visits / number of scheduled visits
Study recruitment potentials	baseline	total number of enrolled subjects / total number of eligible subjects
Adherence to study path	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)	drop-out rate at each single step, total and by arm

Secondary Outcome Measures

Name	Time	Method
Transition ability between sitting and standing	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)	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.
Manual dexterity	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)	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.
Transition ability between standing and prone position	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)	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.
Cognitive functions	from baseline to follow-ups (at 6 months and at 12 months from baseline)	Possible patients' changes in Montreal Cognitive Assessment. This scale ranges from 0 to 30 points, with higher scores meaning a better outcome.
Freezing of gait	from baseline to follow-ups (at 6 months and at 12 months from baseline)	Possible patients' changes in Freezing of Gait Questionnaire. This scale ranges from 0 to 24 points, with higher scores meaning a worse outcome.
Dynamic stability	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)	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.
Movement disorders	from baseline to follow-ups (at 6 months and at 12 months from baseline)	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.
Postural control	from baseline to follow-ups (at 6 months and at 12 months from baseline)	Possible patients' changes in Mini-Balance Evaluation System Test. This scale ranges from 0 to 28 points, with higher scores meaning a better outcome.
Sensory orientation	from baseline to follow-ups (at 6 months and at 12 months from baseline)	Possible patients' changes in Non-Motor Symptom Scale. This scale ranges from 0 to 360 points, with higher scores meaning a worse outcome.
Backward walking ability	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)	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.
Quality of life perception	from baseline to follow-ups (at 6 months and at 12 months from baseline)	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.
Walking ability	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)	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.
Turning ability	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)	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.

Trial Locations

Locations (1)

Azienda Sanitaria Locale CN1; 🇮🇹 Cuneo, Italy