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Completed

NCT Number: NCT07352085

Exoskeleton-assisted Neurorehabilitation

* Objective assesment of the feasibility of integrating the Ekso Bionics - Ekso NR device into outpatient care * Objective assesment of quality of life, functionality and clinical symptomps of patients with stroke, cerebellar ataxia, spinal cord injury, and spastic paraparesis * Comparison of measured data and follow-up of changes in relation to themselves and each other * Analyzing the effects of the exoskeleton among the patients * Assessing the safety, possible side effects and tolerability of the EksoNR

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Key information

Conditions

Stroke Ataxia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebellar Ataxia Cerebellar Diseases Cerebrovascular Disorders Dyskinesias Nervous System Diseases Neurologic Manifestations Paralysis Paraplegia Pathological Conditions, Signs and Symptoms Signs and Symptoms Spastic Paraplegia Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injuries (Complete and Incomplete) Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Somogy County Kaposi Mór Teaching Hospital

Kaposvár, Somogy County, 7400, Hungary

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • confirmed diagnosis of spinal cord injury (at or below the C4 level)
  • having cerebellar ataxia diagnosis
  • confirmed spastic paraparesis
  • ischemic stroke

Exclusion criteria

  • height below 150 cm or above 190 cm
  • body weight exceeded 100 kg
  • multiple strokes in medical history
  • systolic blood pressure less than 120 or higher than 160 mmHg
  • orthostatic hypotension
  • arotid artery stenosis
  • severe heart disease
  • hemophilia
  • traumatic brain injury
  • seizure disorder
  • untreated diabetes
  • abnormal electroencephalography
  • abnormal blood panel
  • use of sedatives
  • irregular medication use
  • severe aphasia (Western Aphasia Battery ≤ 25)
  • severe visual or hearing impairment
  • severe sensory dysfunction
  • severe orthopedic problems
  • alcoholism
  • drug use
  • smoking after diagnosis of stroke
  • unable to walk at least 10 m with or without assistance in 6 minutes
  • BBS score ≤ 32
  • BI score ≤ 70
  • current participation in individual or group exercise program outside of standard physical therapy

Treatment and study plan

Gait training with exoskeleton

Device

EksoNR is a wearable, battery-powered bionic exoskeleton that enables individuals with neurological or muscular injuries, lower limb weakness, paralysis, or gait disorders to stand and walk on flat surfaces. The hip and knee joints are powered by motors, and all movements are performed either by the patient's specific movements or by using an external controller. The robot's functions can be adjusted to determine the level of assistance the device provides to the patient.

Primary outcomes

  1. Functional Independence Measure (FIM)

    Time frame: 4 weeks

    Functional autonomy, scaling 18-126 points. The lower the score, the less self-sufficient the patient is.

  2. Barthel Index (BI)

    Time frame: 4 weeks

    Everyday activities, scaling 0-100 points. The higher the score, the better the self-sufficiency.

Secondary outcomes

  1. Timed Up and Go (TUG)

    Time frame: 4 weeks

    Measures functional mobility and fall risk, scaling 0-180 seconds. The less time, the lower the risk of falling.

  2. Berg Balance Scale (BBS)

    Time frame: 4 weeks

    Measures balance, scaling 0-56 points, with lower scores suggesting good balance/indipandance.

  3. Tinetti

    Time frame: 4 weeks

    Balance and walking, scaling 0-28 points, with lower scores indicating higher fall risk.

  4. Walking Index for Spinal Cord Injury II. (WISCI II.)

    Time frame: 4 weeks

    21 - level ordinal scale scoring walking ability after SCI, from total depenence (0) to independent walking (20).

  5. 6 minute walk test (6MWT)

    Time frame: 4 weeks

    Functional exercise capacity, scaling 0-800 meters. The more meters a patient achieves, the better their cardiopulmonary function.

  6. EG-5D-5L

    Time frame: 4 weeks

    Health-related quality of life, having 5 dimensions and 5 levels, plus a Visual Analogue Scale (EQ-VAS)

  7. WHO Quality of Life (WHOQOL)

    Time frame: 4 weeks

    Measuring quality of life, scoring involves rating items on a 1-5 Likert scale, then tranforming these raw scores into a 0-100 scale for four main domains (Physical Health, Psychological, Social Relationships, Environment). The higher the score, the better the quality of life is.

Sponsors and collaborators

Lead sponsor

Somogy Megyei Kaposi Mór Teaching Hospital

Other

Registry information

Official study title

Exoskeleton-assisted Neurorehabilitation: Current Perspectives and Future Directions - A Pilot Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jan 20, 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.

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