Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547827
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Rehabilitation with and Without Robot and Allied Digital Technologies in Stroke Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Rehabilitation with and Without Robot and Allied Digital Technologies RADTs in Stroke Patients a Pragmatic Multicenter Randomised Controlled Trial on the Effectiveness Acceptability Usability and Economic-organizational Sustainability of RADTs from Subacute to Chronic Phase
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
StrokeFit4
Brief Summary:
Rehabilitation after stroke often employs Robot and Allied Digital Technologies RADTs yet evidence on their effectiveness remains inconclusive due to study heterogeneity and limited sample sizes
This multicentre randomized controlled pragmatic trial aims at comprehensively and accurately assessing the effectiveness of rehabilitation mediated by RADTs after a stroke compared to traditional rehabilitation also considering economic sustainability
This multicentre randomized controlled pragmatic trial aims at comprehensively and accurately assessing the effectiveness of rehabilitation mediated by RADTs after a stroke compared to traditional rehabilitation also considering economic sustainability
Detailed Description:
The aim of this study is to evaluate in a pragmatic trial on a large sample of patients who have experienced a stroke within the six months prior to enrollment the effectiveness of a multimodal treatment using robotics and advanced technologies compared to traditional multimodal treatment in the recovery of activities of daily living
Primary Objective To demonstrate in a population of subacute stroke patients the non-inferiority of a rehabilitation treatment integrated with robotic andor technological devices compared to traditional rehabilitative treatment in the recovery of activities of daily living
Secondary Objectives
To demonstrate the superiority of rehabilitative treatment integrated with robotic andor technological devices compared to traditional rehabilitation treatment in the recovery of activities of daily living should non-inferiority be demonstrated
To compare the improvements between two groups in all targeted domains upper limb sensorimotor abilities lower limb sensorimotor abilities and gait balance cognitive abilities in accordance with the International Classification of Functioning Disability and Health ICF
To analyze the neurophysiological parameters and factors involved in neuroplasticity processes
To compare the time pattern of manual dexterity and walking performance recovery in the two groups
To assess the effects of the rehabilitation treatment in terms of daily life activities and quality of life through medium-term follow-up
To evaluate the acceptability and usability of the rehabilitative treatment integrated with robotic andor technological devices for the patient their family and the healthcare practitioner
To create a predictive model capable of forecasting the effectiveness of robotic and technological treatment in subjects after a stroke based on a detailed description of the patient at baseline using demographic data and clinical picture at admission
To assess the economic sustainability of the rehabilitative treatment integrated with robotic andor technological devices for the patient payer and society through the creation of a model for the assessment and prediction of cost-effectiveness cost-utility and for the healthcare system a Budget Impact Analysis and related sensitivity analyses
The study employs a multicenter multimodal randomized controlled parallel-group 11 interventional design with blinded assessors following a pragmatic approach It will be conducted across multiple clinical centers involved in a national research initiative encompassing both outpatient and inpatient settings Randomization will be centralized and stratified by clinical center latency and clinical setting inpatients or outpatients
The sample size 596 patients was determined considering the following with respect to the primary outcome the change in the modified Barthel Index a the non-inferiority of robotic treatment compared to traditional treatment b a power of 80 c a non-inferiority margin of 5 points d a bilateral 95 confidence interval e a standard deviation of the primary outcome of 20 points Considering these parameters a sample size of 506 patients 253 per group is obtained Additionally considering a dropout rate of 15 a total sample size of 596 patients is obtained The same sample size is sufficient to also demonstrate the potential superiority of robotic treatment In fact considering a significance level of 5 a power of 80 a minimal clinically important difference of the scale of 925 points a standard deviation of 20 points and a dropout rate of 15 a total of 178 patients are required for demonstrating superiority
The experimental group will receive rehabilitation using RADTs within a new organizational model where two physical therapists supervise four to six patients In the control group patients will undergo individual traditional rehabilitation maintaining a 11 patient-to-therapist ratio In both groups patients will undergo comprehensive rehabilitation treatment targeting the following domains a upper limb sensorimotor abilities b lower limb sensorimotor abilities and gait c balance d cognitive abilities
The primary outcome is to demonstrate non-inferiority in activities of daily living as measured by the modified Barthel Index Should non-inferiority be established the study will then evaluate the potential superiority of RADTs in activities of daily living
All participating centers will follow a standardized operating procedure regarding treatment and outcome assessment to ensure consistency across all sites Data will be systematically collected using the REDCap Research Electronic Data Capture platform
Primary Objective To demonstrate in a population of subacute stroke patients the non-inferiority of a rehabilitation treatment integrated with robotic andor technological devices compared to traditional rehabilitative treatment in the recovery of activities of daily living
Secondary Objectives
To demonstrate the superiority of rehabilitative treatment integrated with robotic andor technological devices compared to traditional rehabilitation treatment in the recovery of activities of daily living should non-inferiority be demonstrated
To compare the improvements between two groups in all targeted domains upper limb sensorimotor abilities lower limb sensorimotor abilities and gait balance cognitive abilities in accordance with the International Classification of Functioning Disability and Health ICF
To analyze the neurophysiological parameters and factors involved in neuroplasticity processes
To compare the time pattern of manual dexterity and walking performance recovery in the two groups
To assess the effects of the rehabilitation treatment in terms of daily life activities and quality of life through medium-term follow-up
To evaluate the acceptability and usability of the rehabilitative treatment integrated with robotic andor technological devices for the patient their family and the healthcare practitioner
To create a predictive model capable of forecasting the effectiveness of robotic and technological treatment in subjects after a stroke based on a detailed description of the patient at baseline using demographic data and clinical picture at admission
To assess the economic sustainability of the rehabilitative treatment integrated with robotic andor technological devices for the patient payer and society through the creation of a model for the assessment and prediction of cost-effectiveness cost-utility and for the healthcare system a Budget Impact Analysis and related sensitivity analyses
The study employs a multicenter multimodal randomized controlled parallel-group 11 interventional design with blinded assessors following a pragmatic approach It will be conducted across multiple clinical centers involved in a national research initiative encompassing both outpatient and inpatient settings Randomization will be centralized and stratified by clinical center latency and clinical setting inpatients or outpatients
The sample size 596 patients was determined considering the following with respect to the primary outcome the change in the modified Barthel Index a the non-inferiority of robotic treatment compared to traditional treatment b a power of 80 c a non-inferiority margin of 5 points d a bilateral 95 confidence interval e a standard deviation of the primary outcome of 20 points Considering these parameters a sample size of 506 patients 253 per group is obtained Additionally considering a dropout rate of 15 a total sample size of 596 patients is obtained The same sample size is sufficient to also demonstrate the potential superiority of robotic treatment In fact considering a significance level of 5 a power of 80 a minimal clinically important difference of the scale of 925 points a standard deviation of 20 points and a dropout rate of 15 a total of 178 patients are required for demonstrating superiority
The experimental group will receive rehabilitation using RADTs within a new organizational model where two physical therapists supervise four to six patients In the control group patients will undergo individual traditional rehabilitation maintaining a 11 patient-to-therapist ratio In both groups patients will undergo comprehensive rehabilitation treatment targeting the following domains a upper limb sensorimotor abilities b lower limb sensorimotor abilities and gait c balance d cognitive abilities
The primary outcome is to demonstrate non-inferiority in activities of daily living as measured by the modified Barthel Index Should non-inferiority be established the study will then evaluate the potential superiority of RADTs in activities of daily living
All participating centers will follow a standardized operating procedure regarding treatment and outcome assessment to ensure consistency across all sites Data will be systematically collected using the REDCap Research Electronic Data Capture platform
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None