NCT06497309

Advanced Technology-based Rehabilitation Post-stroke Gait Re-learning

Advanced Technology-based Rehabilitation Programmes to Support Gait Re-learning After Stroke

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: National Institute for Medical Rehabilitation, Hungary · Other Government
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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 patient's 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.

Conditions

• Stroke
• Gait Disorders, Neurologic

Interventions

Type	Name	Description
DEVICE	Treadmill training	Therapy with treadmill-based advanced technology device.
DEVICE	Overground training	Therapy using an advanced technological device enables exercise on the ground.
DEVICE	DIERS	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.
OTHER	Traditional physiotherapy assessments	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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-02-11
• Completion: 2026-02-12
• First posted: 2024-07-11
• Last updated: 2026-03-04

Locations

1 site across 1 country: Hungary