Actively Recruiting

Phase 4
Age: 19Years +
All Genders
ID07147530

Study to Verify Effectiveness and Safety of the Electrically Powered Orthopedic Exercise Device on Gait Ability in Patients With Hip Joint Diseases: Investigator Initiated, Single Center, Single Group Clinical Trial

Led by Yonsei University · Updated on 2025-08-29

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Gait is a vital daily activity that depends on the coordinated function of the nervous and musculoskeletal systems. Disorders affecting gait, such as hip osteoarthritis and osteonecrosis of the femoral head, can reduce quality of life, increase fall risk, and limit physical activity. This study aims to assess whether using the Electrically Powered Orthopedic Exercise Device can improve gait function in patients with hip joint diseases and to evaluate user satisfaction and device safety. Participants will be evaluated in a single group study where gait and balance are tested under two conditions: without wearing the device and while wearing it. After initial assessments without the device, participants complete four adaptation sessions wearing the device, practicing short-distance walking. Following these sessions, gait and balance tests are repeated while wearing the device, along with a satisfaction survey. All procedures are supervised by medical professionals. Throughout the study, participants undergo several walking and balance evaluations including the 10-Meter Walk Test, 6-Minute Walk Test, Timed Up and Go Test, and Berg Balance Scale, both without and with the device. Rest periods are provided between tests to ensure participant comfort. Researchers will analyze changes in gait function, balance ability, and user satisfaction, while monitoring device safety. The total study duration and follow-up are structured around the adaptation and evaluation sessions.

CONDITIONS

Brief Title

Effectiveness and Safety of the Electrically Powered Orthopedic Exercise Device on Gait Ability in Patients With Hip Joint Diseases

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals aged 19 or older
  • Diagnosed with hip osteoarthritis of Kellgren-Lawrence Grade 1-4
  • Diagnosed with avascular necrosis of the femoral head at Association Research Circulation Osseous Stage 1-4
  • Able to sit at the edge of a bed without assistance and stand for 10 seconds regardless of support
  • Functional Ambulatory Category score of 1-3
  • Visited Yongin Severance Hospital, understood the study, and signed informed consent
  • Adequate cognitive ability with Korean Mini-Mental State Examination score 60 20
Not Eligible

You will not qualify if you...

  • Contraindications for lower limb weight-bearing such as severe joint contractures, osteoporosis, or untreated fractures
  • Progressive or unstable brain diseases or neurological paralysis from stroke
  • Active infections or open wounds hindering device use
  • Significant leg length discrepancies
  • Severe deformities or contractures in the lower extremities
  • History of poliomyelitis
  • Unable to maintain seated or standing positions independently
  • Severe spasticity (Modified Ashworth Scale grade 62 2)
  • Bone metastases from cancer
  • Severe internal diseases affecting device use (e.g., cardiovascular or respiratory diseases)
  • Cognitive impairments preventing cooperation with device use
  • Complaints of device-related side effects or potential rehabilitation discontinuation
  • Determined to be pregnant or potentially pregnant based on medical interview
  • Any other clinically significant findings deemed inappropriate by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Evaluation Phase Without Device

Duration - 1 day

Participants undergo assessments of walking ability and balance without wearing the electrically powered orthopedic exercise device. These tests include the 10-Meter Walk Test, 6-Minute Walk Test, Timed Up and Go Test, and Berg Balance Scale with rest provided between assessments.

1 visit (in-person)

Pre-Adaptation Phase

Duration - Up to 8 weeks

Participants attend four adaptation sessions wearing the device to become familiar with its operation and wearing method. Each session involves short-distance walking within 10 meters and appropriate device settings are adjusted to minimize discomfort or anxiety.

4 visits (in-person), spaced up to 2 weeks apart

Evaluation Phase With Device

Duration - 1 day

After completing adaptation sessions, participants undergo assessments of walking ability and balance while wearing the device. The same tests as the initial evaluation are performed, followed by a usability and satisfaction survey regarding the device.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Yongin Severance Hospital

Yongin-si, Gyeonggi-do, South Korea, South Korea, 16995

Actively Recruiting

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Research Team

N

Na Young Kim, MD, PhD

H

Hwi Woo Yang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Comparison of reliability, validity, and responsiveness of the mini-BESTest and Berg Balance Scale in patients with balance disorders.

Marco Godi, Franco Franchignoni, Marco Caligari...

https://pubmed.ncbi.nlm.nih.gov/23023812

Ten Meter Walk Test for motor function assessment with technological devices based on lower members' movements: A systematic review.

Maykol Santos, Eftim Zdravevski, Carlos Albuquerque...

https://pubmed.ncbi.nlm.nih.gov/39904103