Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615947
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2023-09-05
Brief Title:
Conventional Multidisciplinary Gait Rehabilitation VR Robotic Self-balancing Based Gait Rehabilitation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Trial to Compare Conventional Multidisciplinary Gait Rehabilitation With the Atalante Self-balancing Walking System in Patients With Multiple Sclerosis
Status:
ENROLLING_BY_INVITATION
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:
None
Brief Summary:
This trial is a prospective randomized rater-blinded study cRHB N30 vs RAGT N30 For the control group this protocol includes 24 one-hour sessions of cRHB training during 8 weeks three times per week under the supervision of a qualified rehab team
For the intervention group RAGT this protocol includes 24 one-hour sessions of RAGT during 8 weeks three times per week under the supervision of a qualified rehab team
Informed consent will be obtained from patients prior to inclusion in the study which will be carried out in accordance with the Declaration of Helsinki
For the intervention group RAGT this protocol includes 24 one-hour sessions of RAGT during 8 weeks three times per week under the supervision of a qualified rehab team
Informed consent will be obtained from patients prior to inclusion in the study which will be carried out in accordance with the Declaration of Helsinki
Detailed Description:
Aims
Primary Aim
To compare the effect of Robot-Assisted Gait Training RAGT using the Atalante self-balance exoskeleton with conventional rehabilitation training cRHB for improving Walking speed measured by the Timed 10-meters walk test 10-MWT considering a clinically relevant change an improvement of 20 of the velocity ms with respect to the baseline assessment
Secondary Aims
To compare the effect of RAGT using the Atalante self-balance exoskeleton with conventional Rehabilitation training cRHB for improving static balance dynamic balance mobility and self-perception of gait impairment measured with
Static Balance by the Berg Balance Scale BBS considering a clinically relevant change for improvement in balance as measured by BBS was 3 points meaning that individuals are likely to perceive that as a reproducible and clinically important change in their balance performance
Dynamic balance by the Timed Up and Go test TUG
Mobility measured by modified Rivermead Mobility Index mRMI
Self-perception of gait impairment by Multiple Sclerosis Walking Scale-12 MSWS-12
Instrumented gait analysis by the G-walk device assessing gait cycle duration step length propulsion index support phase percentage DI oscillation phase percentage DI doubleunique support phase percentage
To compare the effect of RAGT using the Atalante self-balance exoskeleton with conventional Rehabilitation training cRHB on quality of life emotional status and fatigue measured at pre and post-intervention with
Multiple Sclerosis Quality of Life-54 MSQoL 54 Health Survey Spanish version
Hospital Anxiety and Depression Scale HADs considering a clinically relevant change of 17 points at HADs
The Modified fatigue scale MFIS
The patient physical effort of each session by means of the scale of perception of the effort RPE of Borg at the end of each training
To evaluate the epigenetic blueprint of rehabilitation training by comparing the genome wide chromatin accessibility of peripheral blood mononuclear cells PBMCs before and after RAGT or cRHB by Assay for Transposase-Accessible Chromatin sequencing ATACseq
To test the hypothesis that genome wide chromatin accessibility compared to clinical measures can be useful for identifying molecular mechanisms underlying rehabilitation therapies
To compare the changes induced by RAGT versus cRHB on the overall chromatin accessibility and specific genome regions and pathways
Use the biological samples to provide additional functional and mechanistic information about the rehabilitation effects and subject health disease or state
Materials And methods
Design
This trial is a prospective randomized rater-blinded study cRHB N30 vs RAGT N30
For the control group this protocol includes 24 one-hour sessions of cRHB training during 8 weeks three times per week under the supervision of a qualified rehab team
For the intervention group RAGT this protocol includes 24 one-hour sessions of RAGT during 8 weeks three times per week under the supervision of a qualified rehab team
Additionally peripheral blood 6ml will be taken from all subjects at three timepoints at baseline T1 after the 8 weeks of rehabilitation treatment T2 and if possible one year after T4 Biological samples will then be given a unique identifier and transferred to researchers for analysis
Informed consent will be obtained from patients prior to inclusion in the study which will be carried out in accordance with the Declaration of Helsinki
Enrollment and Screening Subjects will be evaluated for their eligibility from neurorehabilitation and neurology outpatient clinics at the Multiple Sclerosis Center of Catalonia Cemcat
Potential subjects will be referred to the study via Cemcat Physicians A member of the research team will screen the referral and confirm they meet the necessary inclusion and exclusion criteria Following confirmation of criteria potential subjects will be contacted by phone to schedule an initial visit for consent and baseline assessment
Additionally peripheral blood 6ml will also be taken from all subjects at baseline T1
Prior to all testing
Primary Aim
To compare the effect of Robot-Assisted Gait Training RAGT using the Atalante self-balance exoskeleton with conventional rehabilitation training cRHB for improving Walking speed measured by the Timed 10-meters walk test 10-MWT considering a clinically relevant change an improvement of 20 of the velocity ms with respect to the baseline assessment
Secondary Aims
To compare the effect of RAGT using the Atalante self-balance exoskeleton with conventional Rehabilitation training cRHB for improving static balance dynamic balance mobility and self-perception of gait impairment measured with
Static Balance by the Berg Balance Scale BBS considering a clinically relevant change for improvement in balance as measured by BBS was 3 points meaning that individuals are likely to perceive that as a reproducible and clinically important change in their balance performance
Dynamic balance by the Timed Up and Go test TUG
Mobility measured by modified Rivermead Mobility Index mRMI
Self-perception of gait impairment by Multiple Sclerosis Walking Scale-12 MSWS-12
Instrumented gait analysis by the G-walk device assessing gait cycle duration step length propulsion index support phase percentage DI oscillation phase percentage DI doubleunique support phase percentage
To compare the effect of RAGT using the Atalante self-balance exoskeleton with conventional Rehabilitation training cRHB on quality of life emotional status and fatigue measured at pre and post-intervention with
Multiple Sclerosis Quality of Life-54 MSQoL 54 Health Survey Spanish version
Hospital Anxiety and Depression Scale HADs considering a clinically relevant change of 17 points at HADs
The Modified fatigue scale MFIS
The patient physical effort of each session by means of the scale of perception of the effort RPE of Borg at the end of each training
To evaluate the epigenetic blueprint of rehabilitation training by comparing the genome wide chromatin accessibility of peripheral blood mononuclear cells PBMCs before and after RAGT or cRHB by Assay for Transposase-Accessible Chromatin sequencing ATACseq
To test the hypothesis that genome wide chromatin accessibility compared to clinical measures can be useful for identifying molecular mechanisms underlying rehabilitation therapies
To compare the changes induced by RAGT versus cRHB on the overall chromatin accessibility and specific genome regions and pathways
Use the biological samples to provide additional functional and mechanistic information about the rehabilitation effects and subject health disease or state
Materials And methods
Design
This trial is a prospective randomized rater-blinded study cRHB N30 vs RAGT N30
For the control group this protocol includes 24 one-hour sessions of cRHB training during 8 weeks three times per week under the supervision of a qualified rehab team
For the intervention group RAGT this protocol includes 24 one-hour sessions of RAGT during 8 weeks three times per week under the supervision of a qualified rehab team
Additionally peripheral blood 6ml will be taken from all subjects at three timepoints at baseline T1 after the 8 weeks of rehabilitation treatment T2 and if possible one year after T4 Biological samples will then be given a unique identifier and transferred to researchers for analysis
Informed consent will be obtained from patients prior to inclusion in the study which will be carried out in accordance with the Declaration of Helsinki
Enrollment and Screening Subjects will be evaluated for their eligibility from neurorehabilitation and neurology outpatient clinics at the Multiple Sclerosis Center of Catalonia Cemcat
Potential subjects will be referred to the study via Cemcat Physicians A member of the research team will screen the referral and confirm they meet the necessary inclusion and exclusion criteria Following confirmation of criteria potential subjects will be contacted by phone to schedule an initial visit for consent and baseline assessment
Additionally peripheral blood 6ml will also be taken from all subjects at baseline T1
Prior to all testing
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