Skip to main content
OpenTrials
Completed

NCT Number: NCT06497309

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders, Neurologic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute for Medical Rehabilitation

Budapest, Pest County, 1121, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemiparetic patient who has had a stroke;
  • ischaemic or haemorrhagic stroke confirmed by CT or MRI;
  • female or male between 40 and 75 years of age;
  • subgroup 1: less than 3 months since stroke,
  • subgroup 2: more than 3 months but less than 1 year since stroke;
  • physical fitness adequate for the exertion of the treatment;
  • right or left lower limb involvement;
  • score 3 on the Functional Ambulation Categories (FAC) scale, i.e. Indicates a patient who can ambulate on a level surface without manual contact of another person but requires standby guarding of one person either for safety or verbal cueing;
  • or score 4 on the Functional Ambulation Categories (FAC) scale, i.e. Indicates a patient who can ambulate independently on a level surface but requires supervision to negotiate (e.g. stairs, inclines, non-flat surfaces);
  • be able to participate in therapy and cooperate based on cognitive function;
  • signed informed consent.

Exclusion criteria

  • More than 1 year has passed since the stroke;
  • scores less than or equal to 3 on the Functional Ambulation Categories (FAC) scale;
  • patients who were unable to walk independently before the stroke;
  • patients treated with botulinum toxin in the lower limb in the last 3 months;
  • use of other lower limb advanced technology treatments during the study;
  • a person with limited capacity;
  • not physically able to bear weight;
  • severe aphasia (impairment of understanding or expression that severely impedes communication);
  • other condition that precludes the use of C-Mill or Andago:
  • severe emotional disturbance;
  • mentally incapacitated patient;
  • severe contracture or spasticity preventing the patient from being placed in the machine;
  • pregnancy;
  • skin disease in the area of contact with the straps;
  • fever;
  • unhealed fracture fracture;
  • inability to use the device due to weight and height limitations of the device;
  • epilepsy if you have had a seizure within a year;
  • severe visual impairment.

Treatment and study plan

treadmill training

Device

Therapy with treadmill-based advanced technology device.

Overground training

Device

Therapy using an advanced technological device enables exercise on the ground.

DIERS

Device

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.

Traditional physiotherapy assessments

Other

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.

Primary outcomes

  1. Balancing skills

    Time frame: Through study completion, an average of 2 years.

    Berg Balance Test (values between 0-56, higher score means better outcome).

  2. Balancing skills

    Time frame: Through study completion, an average of 2 years.

    Timed Up and Go Test (how many seconds it takes the patient to complete the task).

  3. Balancing skills

    Time frame: Through study completion, an average of 2 years.

    Weight distribution (%) using the DIERS medical device.

  4. Balancing skills

    Time frame: Through study completion, an average of 2 years.

    COP movement (mm) using the DIERS medical device.

  5. Balancing skills

    Time frame: Through study completion, an average of 2 years.

    Sway area (mm2) using the DIERS medical device.

  6. Balancing skills

    Time frame: Through study completion, an average of 2 years.

    Romberg opened eyes, closed eyes (mm) using the DIERS medical device.

  7. Balancing skills

    Time frame: Through study completion, an average of 2 years.

    Strength of the lower limbs (hip extension, flexion, adduction and abduction) and the trunk (flexion, extension, rotation, lateroflexion) (N) using the DIERS medical device.

  8. Gait parameters

    Time frame: Through study completion, an average of 2 years.

    6-minute gait test (m).

  9. Gait parameters

    Time frame: Through study completion, an average of 2 years.

    10-meter gait test (min).

  10. Gait parameters

    Time frame: Through study completion, an average of 2 years.

    step length (mm), using the DIERS medical device.

  11. Gait parameters

    Time frame: Through study completion, an average of 2 years.

    Step width (mm), using the DIERS medical device.

  12. Gait parameters

    Time frame: Through study completion, an average of 2 years.

    Heel strike (N), using the DIERS medical device.

  13. Gait parameters

    Time frame: Through study completion, an average of 2 years.

    COP movement (mm), using the DIERS medical device.

  14. Functional independence

    Time frame: Through study completion, an average of 2 years.

    Based on FIM (maximum 126 points, higher score means better outcome).

  15. Functional independence

    Time frame: Through study completion, an average of 2 years.

    Based on Barthel (values between 0-99, higher score means better outcome).

Sponsors and collaborators

Lead sponsor

National Institute for Medical Rehabilitation, Hungary

Other Gov

Collaborators

  • Semmelweis University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.