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Clinical Trial NCT07502066 (LIDO) for Multiple Sclerosis, Parkinson Disease is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Clinical Efficacy of a telerehabilItation Protocol, for the Improvement of Balance in Degenerative Neurological Diseases (LIDO) 36 Randomized Exercise-Based
Clinical Trial NCT07502066 (LIDO) is an interventional study for Multiple Sclerosis, Parkinson Disease that is active, not recruiting. It started on October 14, 2021 with plans to enroll 36 participants. Led by IRCCS San Camillo, Venezia, Italy, it is expected to complete by December 31, 2026. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief Summary
The goal of this one blind-randomized controlled clinical trial is to evaluate the clinical effectiveness of a telerehabilitation (TR) protocol focusing on balance rehabilitation in patients with neurodegenerative diseases (Parkinson's Disease, Multiple Sclerosis).
The secondary objectives of the study are:
- To evaluate the effects of clinical treatment on Health-Related Quality of Life (HRQOL) outcomes.
- To co...
Detailed Description
Single-blind randomised controlled clinical trial. A sample of 36 consecutive patients (18 per group) suffering from Multiple Sclerosis (N=18, 9 per group) and Parkinson's Disease (N=18, 9 per group), admitted to the San Camillo IRCCS Hospital in Venice in ordinary inpatient or outpatient care, who still need home rehabilitation, will be enrolled. patients will be randomised to receive either TR or usual care, based ...Show More
Official Title
Clinical Efficacy of a teLerehabilItation Protocol, for the Improvement of Balance in Degenerative neurOlogical Diseases
Conditions
Multiple SclerosisParkinson DiseasePublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- LIDO
- 2021.17
NCT ID Number
Start Date (Actual)
2021-10-14
Last Update Posted
2026-03-30
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
36
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
Telerehabilitation
Balance Treatment
remote rehabilitation
remote monitoring
Balance Treatment
remote rehabilitation
remote monitoring
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalTelerehabilitation Group- Multiple Sclerosis (TR-MS) After discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3). The rehabilitation modality provided by the IRCCS in telerehabilitation is based on virtual reality modalities. In particular, the experimental treatment under study involves the use of the VRRS-TR system (Khymeia Group s.r.l, ...Show More | Telerehabilitation Treatment The treatment will last 4 weeks; each session will be1 hour, to be performed five times a week. Patients in the Telerehabilitation group will perform the same balance rehabilitation protocol as the controls, through the telerehabilitation system implemented by the IRCCS, which allows them to perform rehabilitation treatments at home, monitored by a hospital physiotherapist. Both groups will carry out a clinical evalu...Show More |
Active ComparatorControl Group- Multiple Sclerosis (CG-MS) After discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3).Every session will last 1h and will be done 5 times/week for 4 week.The exercises proposed to the control group will be performed by the patient at home, in self-treatment.In order to carry out the therapies, the patient will be...Show More | Conventional Treatment The conventional treatment group will perform a programme of exercises, specific for balance, contained in a booklet, in which there is a description of the activities, accompanied by explanatory pictures. On a weekly basis, a physiotherapist will contact the individuals in this group by telephone to inquire about the progress of the therapy, and provide information on how to possibly modify the mode, number of repet...Show More |
ExperimentalTelerehabilitation Group- Parkinson's Disease (TR-PD) After discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3). Every session will last 1h and will be done 5 times/week for 4 week.The rehabilitation modality provided by the IRCCS in telerehabilitation is based on virtual reality modalities. In particular, the experimental treatment under...Show More | Telerehabilitation Treatment The treatment will last 4 weeks; each session will be1 hour, to be performed five times a week. Patients in the Telerehabilitation group will perform the same balance rehabilitation protocol as the controls, through the telerehabilitation system implemented by the IRCCS, which allows them to perform rehabilitation treatments at home, monitored by a hospital physiotherapist. Both groups will carry out a clinical evalu...Show More |
Active ComparatorControl Group- Parkinson's Disease ( CG-PD) After discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3).Every session will last 1h and will be done 5 times/week for 4 week.The exercises proposed to the control group will be performed by the patient at home, in self-treatment.In order to carry out the therapies, the patient will be...Show More | Conventional Treatment The conventional treatment group will perform a programme of exercises, specific for balance, contained in a booklet, in which there is a description of the activities, accompanied by explanatory pictures. On a weekly basis, a physiotherapist will contact the individuals in this group by telephone to inquire about the progress of the therapy, and provide information on how to possibly modify the mode, number of repet...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Berg Balance Scale | The Berg Balance Scale (BBS) objectively assesses a patient's ability to safely maintain balance during 14 predetermined tasks. Each item is scored on a 5-point ordinal scale (0-4), with 0 indicating the lowest level of function and 4 the highest. The assessment takes approximately 20 minutes and excludes gait evaluation.
Possible scores range from 0 to 56, with higher scores indicating better balance function. | Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Mini-Balance Evaluation System Test (Mini-BESTest) | The Mini-BESTest evaluates dynamic balance, functional mobility, and gait through 14 items across four sections: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait.
Possible scores range from 0 to 28, with higher scores indicating better postural control and balance function. | Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline. |
Functional Ambulation Classification (FAC) | FAC is a 6-point functional walking test that evaluates ambulation ability by determining the level of human support required when walking, regardless of assistive devices used.
Scores range from 0 (non-functional ambulator) to 5 (independent ambulator on any surface), with higher scores indicating better independence in ambulation. | Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline. |
5X Sit-to-Stand Test (5XSST) | 5x Sit-To-Stand Test assesses functional lower extremity strength, transitional movements, balance, and fall risk, measuring the time taken to rise from a chair 5 times.
Scores are time in seconds (typically 5-30 seconds in adults), with lower time ndicating better lower limb strength and balance. | Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline. |
Activities specific-Balance Confidence (ABC) -Scale | ABC scale is s a 16-item questionnaire measuring confidence in performing ambulatory activities without losing balance or feeling unsteady.
Scores range from 0% (no confidence) to 100% (complete confidence), with higher scores indicating greater balance confidence. | Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline. |
Barthel Index (BI) | BI is an ordinal scale measuring performance in 10 activities of daily living (ADL) and mobility, based on time and assistance required.
Scores range from 0 (total dependence) to 100 (complete independence), with higher scores indicating better functional independence. | Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline. |
Six Minutes Walking Test (6MWT) | 6MWT is a sub-maximal exercise test assessing aerobic capacity and endurance by measuring distance covered in 6 minutes.
Scores are distance in meters (typically 300-700m in adults), with greater distances indicating better endurance. | Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline |
Ten metres walking test (10MWT) | 10MWT assesses walking speed in meters per second over a short distance to evaluate functional mobility, gait, and vestibular function.
Scores are time in seconds or speed in m/s (typically 0.8-1.5 m/s), with faster speeds (lower times) indicating better gait performance. | Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline. |
Short-Form-36 health outcome (SF-36) | SF-36 is a self-reported measure of health-related quality of life across eight domains, yielding Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.
Domain scores range 0-100; PCS and MCS standardized to mean 50 (SD 10), with higher scores indicating better health status. | Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline. |
Falls questionnaire (last year-last 2 months) | Self-produced questionnaire monitoring the number of falls occurring during the previous year and the two months prior to administration, including circumstances of falls.
Scores are count of falls (0 or more), with fewer falls indicating better outcome. | Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline. |
EuroQol-5 Dimensions, 3 Levels (EQ-5D-3L) | The EQ-5D is a self-completion questionnaire assessing health-related quality of life across five dimensions plus a visual analog scale, yielding an index score.
Index scores range from -0.594 (worse than dead) to 1 (perfect health), with higher scores indicating better health status. | Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline. |
Instrumental Activities of Daily Living (IADL) | IALS assesses ability to perform complex community-living tasks independently (Lawton scale).
Scores range from 0 (low functioning, dependent) to 8 (high functioning, independent), with higher scores indicating better independence. | Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline. |
Client Satisfaction Measure Questionnaire (SMQ) | Custom questionnaire measuring patient satisfaction with the received therapy. Scores range to be specified (e.g., 0-100 if Likert-based), with higher scores indicating greater satisfaction. | At Post-intervention (T2), approximately 6 weeks after baseline. |
System Usability Scale (SUS) | The System Usability Scale (SUS) is a 10-item questionnaire providing a reliable measure of system usability.
Scores range from 0 to 100, with higher scores indicating better perceived usability (≥68 acceptable). | At Post-intervention (T2), approximately 6 weeks after baseline. |
Technology acceptance questionnaire (TAM) | Custom questionnaire based on the Technology Acceptance Model (TAM), measuring patient acceptance of the technology used through constructs like perceived usefulness, perceived ease of use, and behavioral intention.
Individual items scored on a 7-point Likert scale (1=strongly disagree to 7=strongly agree); composite/mean scores range from 1 to 7, with higher scores indicating greater technology acceptance. | At Post-intervention (T2), approximately 6 weeks after baseline. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Possession of an ADSL internet connection with a flat rate or, in the case of a pay-as-you-go tariff, with an availability of at least 20 Gigabytes/month.
PARKINSON'S DISEASE:
- Patients with Parkinson's disease, according to the criteria of the UK Parkinson's Disease Society Brain Bank, in stabilised pharmacological treatment with L-Dopa or dopamine agonists and with a Hoehn & Yahr scale score between 1.5 and 2.5;
- Patients presenting a score ≤ 2 in the 'freezing when walking' subitem of section II of the UPDRS;
- Patients presenting a score ≤ 2 in both duration and disability in the "dyskinesias" sub-item of section IV of the UPDRS.
MULTIPLE SCLEROSIS
- Subjects with Multiple Sclerosis (MS) in the relapsing remitting (RRMS) or secondary progressive (SPMS) forms, according to the criteria of MC Donald 2010 \[14\], under stable drug treatment and with Expanded Disability Status Scale (EDSS) score ≤ 6.5;
- At the time of inclusion, at least 3 months have elapsed since the last relapse.
- All patients will be excluded from the study who, in association with the diagnosis of the diseases listed above, have the following comorbidities diagnosed and documented in the medical records
- Unstabilised fractures;
- Diagnosis of major depression;
- Severe deficits in visual acuity and hearing perception;
- Dementia;
- Epilepsy not controlled pharmacologically;
- Ideomotor apraxia;
- Neglect;
- Severe impairment of verbal comprehension
IRCCS San Camillo, Venezia, ItalyStudy Responsible Party
Sara Federico, Principal Investigator, Dr, IRCCS San Camillo, Venezia, Italy
No contact data.
1 Study Locations in 1 Countries
IRCCS San Camillo Hospital, Venice-Lido, 30126, Italy