Actively Recruiting

Phase 4
Age: 19Years +
All Genders
ID07147491

Effectiveness and Safety of the Electrically Powered Orthopedic Exercise Device on Gait Ability in Patients Who Have Undergone Hip Surgery

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 controlled by the nervous and musculoskeletal systems. Disorders affecting gait can reduce quality of life, increase fall risk, and limit physical activity, commonly caused by conditions like hip osteoarthritis, avascular necrosis of the femoral head, and hip fractures. While early intervention therapies relieve symptoms, they cannot prevent disease progression, often leading to hip surgeries. Recovery after surgery varies, and some patients struggle to regain normal walking, with risks of overloading the non-operated limb and further complications. This study explores the clinical use of the Electrically Powered Orthopedic Exercise Device (Angel Suit H10) to improve gait function after hip surgery. The study involves 30 participants undergoing evaluations of walking and balance without and then with the device. Participants complete four adaptation sessions wearing the device to become familiar with its use and settings. After adaptation, gait and balance are reassessed while wearing the device, followed by a satisfaction survey. Participants undergo several functional tests including the 10-Meter Walk Test, 6-Minute Walk Test, Timed Up and Go Test, and Berg Balance Scale during both device-free and device-assisted phases. Rest periods are provided between assessments under supervision. The study measures gait parameters, balance, and user satisfaction to assess device safety and effectiveness. The entire process is conducted under medical supervision with clinical information collection and monitoring throughout the study period.

CONDITIONS

Brief Title

Effectiveness and Safety of the Electrically Powered Orthopedic Exercise Device on Gait Ability in Patients With Who Have Undergone Hip Surgery

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals aged 19 or older
  • Individuals who have undergone hip surgery due to hip osteoarthritis, avascular necrosis of the femoral head, or hip fracture
  • Individuals who are at least two days post-hip surgery and are assessed to be medically stable
  • Individuals who have adequate cognitive ability (Korean Mini-Mental State Examination score 20)
  • Individuals able to sit at the edge of a bed without assistance and stand for 10 seconds regardless of support
  • Individuals with a Functional Ambulatory Category (FAC) score of 1-3
  • Individuals who visited Yongin Severance Hospital, understood the study, and signed informed consent
Not Eligible

You will not qualify if you...

  • Individuals with exudate, heat, redness, swelling, or severe pain at the surgical site after hip surgery
  • Individuals with contraindications for lower limb weight-bearing such as severe joint contractures, osteoporosis, or untreated fractures
  • Individuals with progressive or unstable brain diseases or neurological paralysis from stroke
  • Individuals with active infections or open wounds preventing device use
  • Individuals with significant leg length discrepancies
  • Individuals with severe deformities or contractures in the lower extremities
  • Individuals with a history of poliomyelitis
  • Individuals unable to maintain seated or standing positions independently
  • Individuals with severe spasticity (Modified Ashworth Scale grade 2)
  • Individuals with bone metastases from cancer
  • Individuals with severe internal diseases affecting device use, such as cardiovascular or respiratory diseases
  • Individuals with cognitive impairments that prevent cooperation with device use
  • Individuals with complaints of device-related side effects or potential rehabilitation discontinuation, such as severe obesity or skeletal deformity
  • Patients determined to be pregnant or potentially pregnant
  • Individuals with 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 without Device

Duration - 1 day

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

1 visit (in-person)

Pre-Adaptation Phase

Duration - Up to 8 weeks

Participants complete four adaptation sessions wearing the orthopedic exercise device to become familiar with its operation and fit. Each session involves short-distance walking within 10 meters with device settings adjusted individually.

4 visits (in-person), approximately one every two weeks

Evaluation 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 evaluation without the device are conducted, followed by a usability and satisfaction survey.

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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Frequently Asked Questions

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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

Are people following hip and knee arthroplasty at greater risk of experiencing a fall and fracture? Data from the Osteoarthritis Initiative.

T O Smith, M Pearson, S K Latham

https://pubmed.ncbi.nlm.nih.gov/26994762

One-year changes in hind limb kinematics, ground reaction forces and knee stability in an experimental model of osteoarthritis.

E Suter, W Herzog, T R Leonard...

https://pubmed.ncbi.nlm.nih.gov/9755035