Exoskeleton-assisted Neurorehabilitation

N/ACompletedNCT07352085

Somogy Megyei Kaposi Mór Teaching Hospital5 enrolled

Overview

* 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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke Spinal Cord Injuries (Complete and Incomplete)Cerebellar Ataxia Spastic Paraplegia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Functional Independence Measure (FIM)

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

Time frame: 4 weeks

Barthel Index (BI)

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

Time frame: 4 weeks

Secondary Outcomes

Timed Up and Go (TUG)

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

Time frame: 4 weeks

Berg Balance Scale (BBS)

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

Time frame: 4 weeks

Tinetti

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

Time frame: 4 weeks

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

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

Time frame: 4 weeks

6 minute walk test (6MWT)

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

Time frame: 4 weeks

EG-5D-5L

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

Time frame: 4 weeks

WHO Quality of Life (WHOQOL)

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.

Time frame: 4 weeks

Exoskeleton-assisted Neurorehabilitation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes