Ignite Creation Date:
2024-07-17 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497309
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-11
First Post:
2024-04-03
Brief Title:
Advanced Technology-based Rehabilitation Post-stroke Gait Re-learning
Sponsor:
National Institute for Medical Rehabilitation Hungary
Organization:
National Institute for Medical Rehabilitation Hungary
Study Overview
Official Title:
Advanced Technology-based Rehabilitation Programmes to Support Gait Re-learning After Stroke
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
High-tech therapy an innovative field of neurorehabilitation has expanded rapidly in recent years Advances in technology have enabled the use of devices that can assist with movement development from simple movements to more complex tasks
This research investigates the effectiveness of rehabilitation programmes that complement robot-assisted therapy to help people relearn to walk in post-stroke rehabilitation This would be measured in two variations with the patient in addition to a complex rehabilitation programme of conventional physiotherapy occupational therapy hydrotherapy etc receiving either treadmill or no treadmill treatment In both cases the therapies will be carried out with advanced technology-based equipment both treatments are part of the daily routine of the Institutes treatments and the equipment will be used according to the instructions in the user manual the C-Mill interactive robot-assisted device will be used for treadmill therapy and the Andago robot-assisted device for non- treadmill therapy There is no sharp distinction between the two systems The inclusion and exclusion criteria are set so patients conditions meet the indications for both devices and patients eligible for treatment with one device are included in the other
In our study 80 patients will be selected
This research investigates the effectiveness of rehabilitation programmes that complement robot-assisted therapy to help people relearn to walk in post-stroke rehabilitation This would be measured in two variations with the patient in addition to a complex rehabilitation programme of conventional physiotherapy occupational therapy hydrotherapy etc receiving either treadmill or no treadmill treatment In both cases the therapies will be carried out with advanced technology-based equipment both treatments are part of the daily routine of the Institutes treatments and the equipment will be used according to the instructions in the user manual the C-Mill interactive robot-assisted device will be used for treadmill therapy and the Andago robot-assisted device for non- treadmill therapy There is no sharp distinction between the two systems The inclusion and exclusion criteria are set so patients conditions meet the indications for both devices and patients eligible for treatment with one device are included in the other
In our study 80 patients will be selected
Detailed Description:
The main objective of this research is to investigate the effectiveness of rehabilitation programmes in post-stroke rehabilitation using advanced technology-based therapy to assist in relearning walking This will be measured in two variations the patient will be randomly assigned in addition to a complex rehabilitation programme of traditional physiotherapy occupational therapy hydrotherapy etc to receive either treadmill treatment or no treadmill treatment In both cases the therapies are carried out using advanced technological equipment
The investigators will enrol 80 people in our study The comparison will be between 40 and 40 people the main groups differing in terms of the type of advanced technology device used in the rehabilitation programme and whether they received treadmill or non-treadmill treatment In total they will participate in 20 sessions of therapy
Furthermore the investigators observe whether a greater change in condition can be measured in the early post-stroke period 0-3 months or the late period 3 months-1 year in specific parameters of the patients gait The time since the stroke provides an opportunity for subgroup analysis but the number of cases limits this This is significant because it is still an open question in the international literature regarding advanced technology-based therapy
In all cases the examination starts and ends with the DIERS motion analysis system a light-optical scanning method based on VRS Video Raster Stereography and a sensor-equipped treadmill that allows the measurement of several parameters of gait and balancing ability In addition traditional physiotherapy assessment methods Timed Up and Go Berg Balance Test 6-minute gait test 10-metre gait test Functional Independence Measure Barthel are used to assess gait pattern and self-sufficiency
The investigators will enrol 80 people in our study The comparison will be between 40 and 40 people the main groups differing in terms of the type of advanced technology device used in the rehabilitation programme and whether they received treadmill or non-treadmill treatment In total they will participate in 20 sessions of therapy
Furthermore the investigators observe whether a greater change in condition can be measured in the early post-stroke period 0-3 months or the late period 3 months-1 year in specific parameters of the patients gait The time since the stroke provides an opportunity for subgroup analysis but the number of cases limits this This is significant because it is still an open question in the international literature regarding advanced technology-based therapy
In all cases the examination starts and ends with the DIERS motion analysis system a light-optical scanning method based on VRS Video Raster Stereography and a sensor-equipped treadmill that allows the measurement of several parameters of gait and balancing ability In addition traditional physiotherapy assessment methods Timed Up and Go Berg Balance Test 6-minute gait test 10-metre gait test Functional Independence Measure Barthel are used to assess gait pattern and self-sufficiency
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