- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07499063
Effect of Exoskeleton-Assisted Walking on Gait Parameters in Healthy Adults (EKSO-GAIT)
Immediate Effects of a Single Session of Exoskeleton-Assisted Walking on Plantar Pressure Distribution and Gait Parameters in Healthy Young Adults
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sebastian Glowinski, Professor
- Phone Number: +48 502 684 794
- Email: s.glowinski@pans-koszalin.pl
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exoskeleton Walking
Participants undergo baseline gait assessment, followed by a 30-minute walking session using an exoskeleton, and a post-intervention assessment.
|
A wearable robotic exoskeleton used to assist walking during a supervised 30-minute session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in plantar pressure distribution
Time Frame: Immediately before and immediately after intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in spatiotemporal gait parameter
Time Frame: Immediately before and immediately after intervention
|
Evaluation of step length [m]
|
Immediately before and immediately after intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in symmetry
Time Frame: Immediately before and immediately after intervention
|
Change in symmetry [%] using baropodometric analysis
|
Immediately before and immediately after intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EKSO_GAIT_2026_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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