NCT07352085

Brief Summary

  • 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

January 10, 2026

Last Update Submit

January 10, 2026

Conditions

StrokeSpinal Cord Injuries (Complete and Incomplete)Cerebellar AtaxiaSpastic Paraplegia

Keywords

Spinal cord injuryAtaxiaStrokeSpastic paraplegiaAltered gait patternEksobionicsRobotic therapy

Outcome Measures

Primary Outcomes (2)

  • Functional Independence Measure (FIM)

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

    4 weeks

  • Barthel Index (BI)

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

    4 weeks

Secondary Outcomes (7)

  • Timed Up and Go (TUG)

    4 weeks

  • Berg Balance Scale (BBS)

    4 weeks

  • Tinetti

    4 weeks

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

    4 weeks

  • 6 minute walk test (6MWT)

    4 weeks

  • +2 more secondary outcomes

Study Arms (1)

Ekso Group

ACTIVE COMPARATOR

Improving gait with the help of the Eksobionics EksoNR device

Device: Gait training with exoskeleton

Interventions

Gait training with exoskeletonDEVICE

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.

Ekso Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Somogy County Kaposi Mór Teaching Hospital

Kaposvár, Somogy County, 7400, Hungary

Location

MeSH Terms

Conditions

StrokeSpinal Cord InjuriesCerebellar AtaxiaParaplegiaAtaxia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpinal Cord DiseasesTrauma, Nervous SystemWounds and InjuriesCerebellar DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsParalysis

Study Officials

  • József Dr. habil. Tollár

    Somogy County Kaposi Mór Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

January 10, 2026

First Posted

January 20, 2026

Study Start

June 1, 2024

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)