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

NCT06497309 | Completed

• 1 other identifier: OMINT-58-1/2023
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Stroke; Gait Disorders, Neurologic

Keywords

Rehabilitation; Physical Therapy; High-tech devices; Stroke; Gait re-learning

Outcome Measures

Primary Outcomes (15)

• 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.

Study Arms (2)

Treadmill group

In both groups, using advanced technology-based tools (both treatments are part of the daily routine of the Institute's treatments and are used according to the instructions in the user manual), for the treadmill therapy, we use the C-Mill interactive high-tech device.

Device: Treadmill training; Device: DIERS; Other: Traditional physiotherapy assessments

Overground group

In both groups, we use an advanced technology-based device (both treatments are part of the daily routine of the Institute's treatments and are used according to the instructions in the user manual), and the Andago high-tech device for non-runner therapy.

Device: Overground training; Device: DIERS; Other: Traditional physiotherapy assessments

Interventions

Treadmill training DEVICE

Therapy with treadmill-based advanced technology device.

Treadmill group

Overground training DEVICE

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

Overground group

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.

Overground group; Treadmill group

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.

Overground group; Treadmill group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients of the National Institute for Medical Rehabilitation, Budapest, Hungary

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• National Institute for Medical Rehabilitation, Hungary: lead
• Semmelweis University: collaborator

Study Sites (1)

National Institute for Medical Rehabilitation

Budapest, Pest County, 1121, Hungary

Location

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

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

Study Officials

• Gábor Fazekas, MD, PhD

  National Institute for Medical Rehabilitation, Hungary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: July 11, 2024
• Study Start: January 1, 2024
• Primary Completion: February 11, 2026
• Study Completion: February 12, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

HU (1)