Effect of Exoskeleton-Assisted Walking on Gait Parameters... | NCT07499063

Studies
Effect of Exoskeleton-Assisted Walking on Gait Parameters in Healthy Adults

NCT07499063

Sponsor

The State Academy of Applied Sciences in Koszalin

Status

Not yet recruiting

Last Update Posted

Mar 30, 2026Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Gait Analysis in Healthy Subjects

Interventions

Ekso NR Exoskeleton

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2026Estimated

Primary Completion Date

Jun 2026Estimated

Completion Date

Aug 2026Estimated

First Submitted Date

Mar 20, 2026

First Submission Date that Met QC Criteria

Mar 24, 2026

First Posted Date

Mar 30, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2026

Last Update Posted Date

Mar 30, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sebastian Glowinski, Full Prof. DSc Eng, The State Academy of Applied Sciences in KoszalinPrincipal Investigator

Lead Sponsor

The State Academy of Applied Sciences in KoszalinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to evaluate the immediate effects of a single session of exoskeleton-assisted walking on gait parameters and plantar pressure distribution in healthy young adults. Participants will undergo baseline gait assessment using a baropodometric platform, followed by a 30-minute walking session using the Ekso NR exoskeleton. Immediately after the intervention, gait assessment will be repeated. The study is designed as a single-group, pre-post experimental evaluation of biomechanical changes associated with exoskeleton use.

Detailed Description

The purpose of this study is to investigate the immediate biomechanical effects of exoskeleton-assisted walking in healthy individuals. A total of 25 healthy adult participants will be recruited. After screening for eligibility, participants will complete a questionnaire and undergo baseline gait analysis using a baropodometric platform (FreeStep).

Following the baseline assessment, participants will perform a 30-minute walking session using the Ekso NR wearable exoskeleton under supervision. Immediately after completing the session, gait analysis will be repeated using the same baropodometric platform.

Primary outcomes will include changes in plantar pressure distribution parameters, while secondary outcomes will include changes in spatiotemporal gait parameters such as step length, cadence, and symmetry.

The study is designed as a single-arm, pre-post interventional study focusing on biomechanical assessment rather than therapeutic intervention. The results will contribute to understanding the effects of exoskeleton-assisted walking on gait in healthy individuals.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exoskeleton Walking	Experimental	Participants undergo baseline gait assessment, followed by a 30-minute walking session using an exoskeleton, and a post-intervention assessment.	Device: Ekso NR Exoskeleton

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ekso NR Exoskeleton	Device	A wearable robotic exoskeleton used to assist walking during a supervised 30-minute session.	Exoskeleton Walking

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in plantar pressure distribution	Assessment of plantar pressure parameters measured using a baropodometric platform before and immediately after exoskeleton-assisted walking [kg/cm^2].	Immediately before and immediately after intervention

Secondary Outcomes

Measure	Description	Time Frame
Change in spatiotemporal gait parameter	Evaluation of step length [m]	Immediately before and immediately after intervention

Other Outcomes

Measure	Description	Time Frame
Change in symmetry	Change in symmetry [%] using baropodometric analysis	Immediately before and immediately after intervention

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adults aged 19-25 years
No history of musculoskeletal or neurological disorders
Ability to walk independently

Exclusion Criteria:

Any current injury affecting gait
Neurological or orthopedic conditions
Contraindications to exoskeleton use

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sebastian Glowinski, Professor	Contact	502 684 794	+48	s.glowinski@pans-koszalin.pl

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Individual participant data may be shared upon reasonable request, in accordance with institutional policies and applicable data protection regulations.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Model Description

Single-group, pre-post study design in which all participants undergo baseline assessment, followed by a single session of exoskeleton-assisted walking, and a post-intervention assessment.