Ignite Creation Date:
2024-07-17 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485115
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-17
Brief Title:
Telerehabilitation in Progressive Multiple Sclerosis
Sponsor:
Universita di Verona
Organization:
Universita di Verona
Study Overview
Official Title:
The Effectiveness of Combining a Home-based Digital Motor Telerehabilitation Program With Conventional Therapy in Progressive Multiple Sclerosis a Multicentre Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multiple sclerosis MS is a highly disabling chronic inflammatory demyelinating disease of the Central Nervous System CNS Significant progress has been made during the past three decades in managing the relapsing-remitting phase of Multiple Sclerosis RRMS However once patients have entered the progressive stage of MS secondary progressive SPMS therapeutic options are limited to symptomatic treatments and rehabilitation In addition 10-20 of patients experience unremitting disease progression primary progressive MS or PPMS The limited research focusing on Progressive MS PMS and the lack of ecological validity highlight the need for a bolder approach that combines more than one intervention intending to produce synergistic effects The primary aim is to test the effectiveness of combining a home-based Digital Telerehabilitation program with in-hospital rehabilitation on mobility against in-hospital rehabilitation alone
Detailed Description:
The literature emphasizes a striking dearth of studies devoted solely to people with SPMS or PPMS and the lack of ecological validity in assessing the results This suggests that an additional effort is required a bolder approach that combines more than one intervention intending to produce synergistic effects an improvement in one area boosting the putative benefits of therapy in another the overall outcome exceeding the sum of the individual treatments
The primary aim will be to test the effectiveness of combining a home-based digital motor telerehabilitation program experimental intervention with in-hospital rehabilitation on mobility primary outcome against in-hospital rehabilitation without any additional therapy except for general instructions for self-management as usual care conventional treatment in patients with SPMS or PPMS
The secondary aims will be to explore the effects on measures of motor and cognitive function the patients reported outcomes on balance and upper extremity function fatigue pain anxiety and depressive symptoms the self-perception of clinical change and Health-Related Quality of Life Furthermore the investigators will explore the patients perspective and experience with Digital Telerehabilitation post-treatment using quantitative-qualitative methods EG intervention An economic evaluation of the introduction of the digital telemedicine program will be carried out within the health technology assessment HTA framework considering the perspective of the healthcare system and society as a whole
This single-blind RCT with 2-parallel arms will compare the effects between the experimental group EG and control group CG After the screening an administrator external to research groups the principal investigator will generate a block randomization list at each Unit to prevent selection bias using an automated randomization system wwwrandomizationcom allocation ratio 11 to assign eligible patients to either the EG or the CG Patients will be stratified according to the EDSS 6 and 6 Group allocation will be kept concealed All patients will receive an individualized ten sessions of an in-hospital rehabilitation program 1 hourday 3 daysweek by a qualified physiotherapist at each participating unit Then the EG will follow a 12-week individualized Digital Telerehabilitation program 1 hourday 3 daysweek EG while the CG will not receive any additional therapy except for general instructions for self-management according to the allocation group All the patients will undergo four clinical evaluations before T0 and after T1 the in-hospital rehabilitation program 12 weeks T2 and 24 weeks follow-up T3 after it One researcher assistant with experience in assessing primary and secondary outcomes blinded to group assignment will evaluate study participants at all time points in each Unit
The primary aim will be to test the effectiveness of combining a home-based digital motor telerehabilitation program experimental intervention with in-hospital rehabilitation on mobility primary outcome against in-hospital rehabilitation without any additional therapy except for general instructions for self-management as usual care conventional treatment in patients with SPMS or PPMS
The secondary aims will be to explore the effects on measures of motor and cognitive function the patients reported outcomes on balance and upper extremity function fatigue pain anxiety and depressive symptoms the self-perception of clinical change and Health-Related Quality of Life Furthermore the investigators will explore the patients perspective and experience with Digital Telerehabilitation post-treatment using quantitative-qualitative methods EG intervention An economic evaluation of the introduction of the digital telemedicine program will be carried out within the health technology assessment HTA framework considering the perspective of the healthcare system and society as a whole
This single-blind RCT with 2-parallel arms will compare the effects between the experimental group EG and control group CG After the screening an administrator external to research groups the principal investigator will generate a block randomization list at each Unit to prevent selection bias using an automated randomization system wwwrandomizationcom allocation ratio 11 to assign eligible patients to either the EG or the CG Patients will be stratified according to the EDSS 6 and 6 Group allocation will be kept concealed All patients will receive an individualized ten sessions of an in-hospital rehabilitation program 1 hourday 3 daysweek by a qualified physiotherapist at each participating unit Then the EG will follow a 12-week individualized Digital Telerehabilitation program 1 hourday 3 daysweek EG while the CG will not receive any additional therapy except for general instructions for self-management according to the allocation group All the patients will undergo four clinical evaluations before T0 and after T1 the in-hospital rehabilitation program 12 weeks T2 and 24 weeks follow-up T3 after it One researcher assistant with experience in assessing primary and secondary outcomes blinded to group assignment will evaluate study participants at all time points in each Unit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None