- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07450989
Effects of Hip-Assist Exoskeleton Torque on Gait Parameters
Effects of Assistive Hip Exoskeleton Torque on Spatiotemporal, Kinematic, Electromyographic, and Plantar Pressure Parameters During Walking in Healthy Adults
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, South Korea, 03722
- Recruiting
- Severance Hospital
-
Contact:
- Dong Wook Rha, MD, PhD
- Phone Number: 82-2-2228-3717
- Email: medicus@yuhs.ac
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adults aged 19 years or older without gait impairment.
- Body weight between 50kg and 100kg.
- No history of hip surgery.
- Capable of wearing a hip-assist exoskeleton.
- Voluntarily signed the informed consent form.
Exclusion Criteria:
- Skin or musculoskeletal issues that prevent wearing the exoskeleton.
- Inability to walk independently while wearing the exoskeleton.
- Other conditions deemed inappropriate by the investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy Adult Group
Healthy adult males and females aged 19 years or older, with a body weight ranging from 50 kg to 100 kg, who meet all inclusion criteria and have no history of hip surgery or gait impairment.
|
A wearable robot that provides assistive torque (Flexion/Extension) to the hip joint during walking.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Step Length
Time Frame: Day 1
|
Distance between the point of initial contact of one foot and the point of initial contact of the opposite foot. Unit: Meters (m) |
Day 1
|
|
Stride Length
Time Frame: Day 1
|
Distance between successive points of initial contact of the same foot.
Unit: Meters (m)
|
Day 1
|
|
Cadence
Time Frame: Day 1
|
Number of steps taken per minute.
Unit: steps/min
|
Day 1
|
|
Gait Speed
Time Frame: Day 1
|
verage walking speed during the 10-meter walk test.
Unit: Meters per second (m/s)
|
Day 1
|
|
Single/Double Limb Support Phase
Time Frame: Day 1
|
The duration of time when one or both feet are in contact with the ground.
Unit: Percentage of gait cycle (% GC)
|
Day 1
|
|
Hip Joint Range of Motion
Time Frame: Day 1
|
The maximum excursion of the hip joint in the sagittal plane during the gait cycle. Unit: Degrees |
Day 1
|
|
Knee Joint Range of Motion
Time Frame: Day 1
|
The maximum excursion of the knee joint in the sagittal plane during the gait cycle. Unit: Degrees |
Day 1
|
|
Ankle Joint Range of Motion
Time Frame: Day 1
|
The maximum excursion of the ankle joint in the sagittal plane during the gait cycle. Unit: Degrees |
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Activation of Rectus Femoris
Time Frame: Day 1
|
Mean Root Mean Square (RMS) value of the rectus femoris muscle during the gait cycle. Unit: Microvolts |
Day 1
|
|
Muscle Activation of Vastus Medialis
Time Frame: Unit: Microvolts
|
Unit: Microvolts
|
Unit: Microvolts
|
|
Muscle Activation of Medial Hamstring
Time Frame: Day 1
|
Unit: Microvolts
|
Day 1
|
|
Muscle Activation of Tibialis Anterior
Time Frame: Day 1
|
Unit: Microvolts
|
Day 1
|
|
Muscle Activation of Gastrocnemius
Time Frame: Day 1
|
Unit: Microvolts
|
Day 1
|
|
Peak Plantar Pressure
Time Frame: Day 1
|
The maximum pressure recorded under the foot during the stance phase.
Unit: N/cm^2
|
Day 1
|
|
Pressure-Time Integral (PTI)
Time Frame: Day 1
|
The integral of pressure over the time of contact.
Unit: Ns/cm^2
|
Day 1
|
Collaborators and Investigators
Sponsor
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
- 1-2025-0068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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