Advanced Technology-based Rehabilitation Post-stroke Gait Re-learning
NCT Number: NCT06497309
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Stroke|Gait Disorders, Neurologic
Interventions: DEVICE: Treadmill training|DEVICE: Overground training|DEVICE: DIERS|OTHER: Traditional physiotherapy assessments
Sponsor: National Institute for Medical Rehabilitation, Hungary
Collaborators: Semmelweis University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-26
Completion Date: 2026-06-01
Locations: National Institute for Medical Rehabilitation, Budapest, Pest, 1121, Hungary

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 Institute's 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.

Primary Outcome Measures: Balancing skills, Berg Balance Test (values between 0-56, higher score means better outcome)., Through study completion, an average of 2 years.|Balancing skills, Timed Up and Go Test (how many seconds it takes the patient to complete the task)., Through study completion, an average of 2 years.|Balancing skills, Weight distribution (%) using the DIERS medical device., Through study completion, an average of 2 years.|Balancing skills, COP movement (mm) using the DIERS medical device., Through study completion, an average of 2 years.|Balancing skills, Sway area (mm2) using the DIERS medical device., Through study completion, an average of 2 years.|Balancing skills, Romberg opened eyes, closed eyes (mm) using the DIERS medical device., Through study completion, an average of 2 years.|Balancing skills, Strength of the lower limbs (hip extension, flexion, adduction and abduction) and the trunk (flexion, extension, rotation, lateroflexion) (N) using the DIERS medical device., Through study completion, an average of 2 years.|Gait parameters, 6-minute gait test (m)., Through study completion, an average of 2 years.|Gait parameters, 10-meter gait test (min)., Through study completion, an average of 2 years.|Gait parameters, step length (mm), using the DIERS medical device., Through study completion, an average of 2 years.|Gait parameters, Step width (mm), using the DIERS medical device., Through study completion, an average of 2 years.|Gait parameters, Heel strike (N), using the DIERS medical device., Through study completion, an average of 2 years.|Gait parameters, COP movement (mm), using the DIERS medical device., Through study completion, an average of 2 years.|Functional independence, Based on FIM (maximum 126 points, higher score means better outcome)., Through study completion, an average of 2 years.|Functional independence, Based on Barthel (values between 0-99, higher score means better outcome)., Through study completion, an average of 2 years.