Gait Analysis in Healthy SubjectsEKSO-GAITNCT07499063
Effect of Exoskeleton-Assisted Walking on Gait Parameters in Healthy Adults
A study testing Ekso NR Exoskeleton in people with Gait Analysis in Healthy Subjects, run by The State Academy of Applied Sciences in Koszalin at 1 site in Poland.
Trial summary
This study investigated the immediate effects of a single session of EksoNR-assisted walking on gait parameters and plantar pressure distribution in healthy young adults. Participants underwent a baseline assessment using a baropodometric platform, followed by one supervised exoskeleton-assisted walking session and a… Read more about this study
- Who is it for?
- Ages 19 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gait Analysis in Healthy Subjects
- What is being tested?
- Ekso NR Exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePoland
- Study dates
- 10 May 2026to 10 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women aged 19-25 years
- No history of musculoskeletal or neurological disorders
- Ability to walk independently
Who cannot join
- Any current injury affecting gait
- Neurological or orthopedic conditions
- Contraindications to exoskeleton use
Trial locations and contacts
1 site in 1 country.
Poland1 site
State Academy of Applied Sciences in Koszalin
Koszalin, West Pomeranian Voivodeship, 75-453
About this study
Official title: Immediate Effects of a Single Session of Exoskeleton-Assisted Walking on Plantar Pressure Distribution and Gait Parameters in Healthy Young Adults
This study investigated the immediate effects of a single session of EksoNR-assisted walking on gait parameters and plantar pressure distribution in healthy young adults. Participants underwent a baseline assessment using a baropodometric platform, followed by one supervised exoskeleton-assisted walking session and a post-intervention assessment. The study used a single-group pre-post design to examine short-term biomechanical changes associated with exoskeleton-assisted walking.
Read the detailed description
The study investigated the immediate biomechanical effects of exoskeleton-assisted walking in healthy young adults. A total of 25 participants underwent screening for eligibility, completed a questionnaire, and performed baseline gait analysis using a baropodometric platform (FreeStep).
Participants then completed a supervised session of walking with the EksoNR wearable exoskeleton. Gait analysis was repeated immediately after the intervention using the same platform.
The primary outcome was the change in plantar pressure distribution. Secondary outcomes included changes in spatiotemporal gait parameters, including step length. Changes in gait symmetry were also assessed. The study used a single-group pre-post design and focused on immediate biomechanical changes rather than therapeutic efficacy.
- Conditions
- Gait Analysis in Healthy Subjects
- Being tested
- Ekso NR Exoskeleton
- Keywords
- exoskeleton, gait analysis, plantar pressure, biomechanics, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ekso NR ExoskeletonDevice
A wearable robotic exoskeleton used to assist walking during a supervised 30-minute session.
| Study group | Role | What they receive |
|---|---|---|
| Exoskeleton Walking | Experimental | Participants underwent baseline gait assessment, followed by a single session of exoskeleton-assisted walking using the EksoNR device, and a post-intervention assessment performed immediately after the session. Receives: Device: Ekso NR Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in step length
Change in step length measured using baropodometric gait analysis.
Measured: Immediately before and immediately after the intervention.
Secondary outcomes (1)
Change in cadence
Change in gait cadence measured using baropodometric gait analysis.
Measured: Immediately before and immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start10 May 2026
- Primary completion1 Jun 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Analysis in Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The State Academy of Applied Sciences in Koszalin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Glowinski, The State Academy of Applied Sciences in Koszalin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499063
- Sponsor's protocol ID
- EKSO_GAIT_2026_01
- Acronym
- EKSO-GAIT
- Status last verified
- Oct 2026
- First submitted
- 20 Mar 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data may be shared upon reasonable request, subject to institutional policies, ethical approval requirements, and applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of a Single Session of Exoskeleton-Assisted Walking on Plantar Pressure Distribution and Gait Parameters in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT07499063
- Acronym / sponsor ID
- EKSO-GAIT / EKSO_GAIT_2026_01
- Conditions
- Gait Analysis in Healthy Subjects
- Keywords
- exoskeleton, gait analysis, plantar pressure, biomechanics, healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The State Academy of Applied Sciences in KoszalinUniversity, hospital or other
- Study start
- 10 May 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated the immediate effects of a single session of EksoNR-assisted walking on gait parameters and plantar pressure distribution in healthy young adults. Participants underwent a baseline assessment using a baropodometric platform, followed by one supervised exoskeleton-assisted walking session and a post-intervention assessment. The study used a single-group pre-post design to examine short-term biomechanical changes associated with exoskeleton-assisted walking.
Detailed description
The study investigated the immediate biomechanical effects of exoskeleton-assisted walking in healthy young adults. A total of 25 participants underwent screening for eligibility, completed a questionnaire, and performed baseline gait analysis using a baropodometric platform (FreeStep).
Participants then completed a supervised session of walking with the EksoNR wearable exoskeleton. Gait analysis was repeated immediately after the intervention using the same platform.
The primary outcome was the change in plantar pressure distribution. Secondary outcomes included changes in spatiotemporal gait parameters, including step length. Changes in gait symmetry were also assessed. The study used a single-group pre-post design and focused on immediate biomechanical changes rather than therapeutic efficacy.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton Walking | Experimental | Device: Ekso NR ExoskeletonParticipants underwent baseline gait assessment, followed by a single session of exoskeleton-assisted walking using the EksoNR device, and a post-intervention assessment performed immediately after the session. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women aged 19-25 years
- No history of musculoskeletal or neurological disorders
- Ability to walk independently
Key exclusion criteria (3 listed)
- Any current injury affecting gait
- Neurological or orthopedic conditions
- Contraindications to exoskeleton use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ekso NR ExoskeletonA wearable robotic exoskeleton used to assist walking during a supervised 30-minute session. | Device | Exoskeleton Walking |
Primary outcome
Change in step length
Time frame: Immediately before and immediately after the intervention.
Change in step length measured using baropodometric gait analysis.
1 secondary outcome
Change in cadence
Time frame: Immediately before and immediately after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data may be shared upon reasonable request, subject to institutional policies, ethical approval requirements, and applicable data protection regulations.
Related trials for Gait Analysis in Healthy Subjects
Not yet recruiting
The Effect of Lateral Wedge Insoles on Lower Limb Biomechanics, Muscle Activity and Knee Adduction Moment During Walking and Running
Biomechanical Changes, Gait Biomechanics
Recruiting
Gait Analysis Parameter and Upper Limb Evaluation in Control Participants
Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ekso NR Exoskeleton in people with Gait Analysis in Healthy Subjects, run by The State Academy of Applied Sciences in Koszalin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in step length (time frame: Immediately before and immediately after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.