Exoskeleton-assisted Neurorehabilitation

Somogy Megyei Kaposi Mór Teaching Hospital

Status: Completed

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

Treatments: Device: Gait training with exoskeleton

Study type: Interventional

Funder types: Other

Identifiers

NCT07352085

IKEB2023/10

Details and patient eligibility

About

• 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

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

Ekso Group

Active Comparator group

Description:

Improving gait with the help of the Eksobionics EksoNR device

Treatment:

Device: Gait training with exoskeleton