Hip DiseasePhase 4NCT07147530
Effectiveness and Safety of the Electrically Powered Orthopedic Exercise Device on Gait Ability in Patients With Hip Joint Diseases
A Phase 4 study testing Electrically Powered Orthopedic Exercise Device in people with Hip Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Gait is an essential daily activity performed through the complex coordination of the central and peripheral nervous systems and the musculoskeletal system. Gait disorders can negatively affect quality of life, increase the risk of falls, decrease the ability to perform daily activities, and limit physical activity. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hip Disease
- What is being tested?
- Electrically Powered Orthopedic Exercise Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Apr 2025to 6 Apr 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 19 or older
- Individuals diagnosed with hip osteoarthritis of Kellgren-Lawrence (K-L) Grade 1-4
- Individuals diagnosed with avascular necrosis of the femoral head at Association Research Circulation Osseous(ARCO) Stage 1-4
- Individuals able to sit at the edge of a bed without assistance and stand for 10 seconds regardless of support
- Individuals who are Functional Ambulatory Category (FAC) score of 1-3
- Individuals who visited Yongin Severance Hospital, understood the study, and signed informed consent
- Individuals who have adequate cognitive ability (Korean Mini-Mental State Examination score ≥ 20)
Who cannot join
- Individuals who have contraindications for lower limb weight-bearing such as severe joint contractures, osteoporosis, or untreated fractures
- Individuals who have progressive or unstable brain diseases or neurological paralysis from stroke
- Individuals who have active infections or open wounds hindering device use
- Individuals who have significant leg length discrepancies
- Individuals who have severe deformities or contractures in the lower extremities
- Individuals who have history of poliomyelitis
Show all 14Show fewer
- Individuals inable to maintain seated or standing positions independently
- Individuals who have severe spasticity (Modified Ashworth Scale grade ≥ 2)
- Individuals who have bone metastases from cancer
- Individuals who have severe internal diseases affecting device use (e.g., cardiovascular or respiratory diseases)
- Individuals who have cognitive impairments preventing cooperation with device use
- Individuals who have complaints of device-related side effects or potential rehabilitation discontinuation
- Patients who are determined to be pregnant or potentially pregnant based on the medical interview
- Individuals who have any other clinically significant findings deemed inappropriate by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea, 16995
Na Young Kim, +82 010 9127 4482, kny8452@yuhs.ac
Hwi Woo Yang, +82 010 7360 4439, Rehab5@yuhs.ac
About this study
Official title: 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
Gait is an essential daily activity performed through the complex coordination of the central and peripheral nervous systems and the musculoskeletal system. Gait disorders can negatively affect quality of life, increase the risk of falls, decrease the ability to perform daily activities, and limit physical activity. Various musculoskeletal diseases can cause gait impairment, with hip osteoarthritis and osteonecrosis of the femoral head (ONFH) being the most representative conditions.
Various interventions can be attempted during the early stages of hip joint disease progression. However, improvement in symptoms does not necessarily indicate a halt in disease progression. As the condition advances in most patients, thinning of the full-thickness hip cartilage or collapse of the femoral head occurs, leading to restricted hip range of motion, weakness of the lower limb muscles and functional deterioration, resulting in the need for total hip arthroplasty.
Read more
THA offers significant improvements in pain relief and function, regardless of the patient's preoperative status, and can reduce long-term healthcare costs. However, performing THA at an early stage with minimal functional improvement is not recommended. Postoperative complications, such as infections, aseptic loosening, and instability, are potential risks, with younger patients aged 45-64 showing higher revision surgery rates compared to those aged 65 and older. This highlights the need for new interventions that can delay the time to surgery while improving gait function and muscle strength.
Therefore, this study aims to explore the clinical feasibility of the Angel Suit H10 (Angelrobotics, Seoul, Korea) by assessing whether wearing the Electrically Powered Orthopedic Exercise Device improves gait function in patients with hip joint diseases, along with evaluating user satisfaction and device safety.
Read the detailed description
(1) Overview of study design This investigator-initiated exploratory study is a pilot study designed to evaluate the effectiveness and safety of the Electrically Powered Orthopedic Exercise Device by measuring and analyzing gait function and balance ability in patients with hip joint diseases under both non-wearing and wearing conditions.
(2) Experimental Group and Evaluation Procedures
- Participant Selection: This study includes a single test group with a total of 30 participants. The selection of participants for the electrically powered orthopedic exercise device and the overall study process will be conducted under the prescription and guidance of a rehabilitation medicine specialist, and supervised by assistants (physicians and occupational therapists). The examiner will collect clinical information and conduct a screening assessment for each participant.
- Evaluation Phase Without Device: After the screening test, participants undergo assessments of walking ability and balance without wearing the motorized orthopedic exercise device. A 10-minute rest period is provided between each assessment. If the participant wishes, additional rest time is allowed and recorded in the case report form. The assessments include the 10-Meter Walk Test, the 6-Minute Walk Test, the Timed Up and Go Test, and the Berg Balance Scale. These evaluations are conducted in the rehabilitation function testing room on the second floor of the facility under the supervision of the research team (physician and either a physical or occupational therapist).
- Pre-Adaptation Phase: After the evaluations without the device, a total of four adaptation sessions are conducted, during which the participant wears the device and performs short-distance walking within 10 meters. These sessions are designed to help the participant become familiar with the operation and wearing method of the H10 device. Appropriate device settings are configured for each participant to minimize any potential inexperience or anxiety during use. Participants must complete all four adaptation sessions, and each session should be conducted within a two-week interval.
- Evaluation Phase:
After completing all four adaptation sessions, participants undergo assessments of walking ability and balance while wearing the motorized orthopedic exercise device. A 10-minute rest period is provided between each assessment. If the participant wishes, additional rest time is allowed and recorded in the case report form. The assessments include the 10-Meter Walk Test, the 6-Minute Walk Test, the Timed Up and Go Test, and the Berg Balance Scale. These evaluations are conducted in the rehabilitation function testing room on the second floor of the facility under the supervision of the research team (physician and either a physical or occupational therapist). After the evaluations are completed, a usability and satisfaction survey regarding the motorized orthopedic exercise device is conducted.
- Conditions
- Hip Disease
- Being tested
- Electrically Powered Orthopedic Exercise Device
- Keywords
- Rehabilitation, Gait, Wearable robot, Hip joint disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrically Powered Orthopedic Exercise DeviceDevice
Participants who pass the screening undergo an evaluation of gait function and balance ability without wearing the Electrically Powered Orthopedic Exercise Device. Afterward, the patient wears the motorized orthopedic exercise device for a total of four adaptation sessions. In each session, the patient performs short-distance walking within 10 meters while wearing the device to explore the appropriate assistive mode and level of support that match their physical condition. No evaluations are conducted while wearing the device during sessions 1, 2, and 3. After the 4th session, an evaluation identical to the one conducted without the device is performed while wearing it, and a satisfaction survey is conducted.
| Study group | Role | What they receive |
|---|---|---|
| Wearing conditions of Electrically Powered Orthopedic Exercise Device | Experimental | Participants will undergo gait and balance function tests under both non-wearing and wearing conditions of the electrically powered orthopedic exercise device Receives: Device: Electrically Powered Orthopedic Exercise Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-Meter Walk Test
Patients are instructed to walk 14 m, including 2 m at both ends for acceleration and deceleration, at their comfortable speed. Gait speed was calculated by dividing the 10m distance by the time taken.
Measured: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
Secondary outcomes (9)
Timed Up and Go (TUG) Test
Researchers ask patients to rise from a seated position, walk a distance of 3 m, turn around, return to the chair, and sit back. The average time of three trials was recorded as a result
Measured: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
6-Minute Walk Test
Patients are instructed to walk back and forth along the 30-meter path as many times as possible within 6 minutes. The examiner records the total distance covered, abnormal gait patterns, and the time of occurrence of any gait deviations.
Measured: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
Berg balance scale (BBS)
Patients are asked to perform 14 tasks regarding the static and dynamic balance of patients. Each task was rated on a five-point scale from 0 to 4, with a total score of 56.
Measured: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
Spatiotemporal Parameters of Gait : Total Step Count
While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded.
Total Step Count: The total number of steps taken during walking.
Measured: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
Spatiotemporal Parameters of Gait : Cadence
While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded.
Cadence: The number of steps taken per minute, measured in steps per minute (spm).
Measured: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
Spatiotemporal Parameters of Gait : Self-Selected Walking Speed
While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded.
Self-Selected Walking Speed: The participant's walking speed when walking naturally at a comfortable pace.
Measured: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
Spatiotemporal Parameters of Gait : Distance
While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded.
Distance: The total distance covered during walking, measured in meters (m).
Measured: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
Spatiotemporal Parameters of Gait : Stride Length
While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded.
Stride Length: The distance between the heel of one foot to the heel of the same foot during consecutive steps. Measured in meters (m), stride length is adjusted for height to account for differences in body size.
Measured: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
Satisfaction evaluation
Participants will complete a satisfaction survey for usability and satisfaction assessment of the electrically powered orthopedic exercise device, based on the Korean version of the Quebec User Evaluation of Satisfaction with assistive Technology (K-QUEST 2.0).21 This survey consists of 12 items on a 5-point scale. Participants rate their satisfaction with the assistive device and related services
Measured: Upon completion of the end-point assessment conducted on the same day as session 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start7 Apr 2025
- Primary completion6 Apr 2026 (estimated)
- Study completion6 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Hip DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Researchers will compare non-wearing and wearing conditions of the electrically powered orthopedic exercise device walking speeds, spatiotemporal parameters, balance in participants and does not establish a control group.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Na Young Kim, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147530
- Sponsor's protocol ID
- 9-2025-0018
- Status last verified
- Aug 2025
- First submitted
- 21 Apr 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Godi M, Franchignoni F, Caligari M, Giordano A, Turcato AM, Nardone A. Comparison of reliability, validity, and responsiveness of the mini-BESTest and Berg Balance Scale in patients with balance disorders. Phys Ther. 2013 Feb;93(2):158-67. doi: 10.2522/ptj.20120171. Epub 2012 Sep 27.
PubMed 23023812Guyatt GH, Sullivan MJ, Thompson PJ, Fallen EL, Pugsley SO, Taylor DW, Berman LB. The 6-minute walk: a new measure of exercise capacity in patients with chronic heart failure. Can Med Assoc J. 1985 Apr 15;132(8):919-23.
PubMed 3978515Hwang R, Morris NR, Mandrusiak A, Mudge A, Suna J, Adsett J, Russell T. Timed Up and Go Test: A Reliable and Valid Test in Patients With Chronic Heart Failure. J Card Fail. 2016 Aug;22(8):646-50. doi: 10.1016/j.cardfail.2015.09.018. Epub 2015 Oct 9.
PubMed 26456063Santos M, Zdravevski E, Albuquerque C, Coelho PJ, Pires IM. Ten Meter Walk Test for motor function assessment with technological devices based on lower members' movements: A systematic review. Comput Biol Med. 2025 Mar;187:109734. doi: 10.1016/j.compbiomed.2025.109734. Epub 2025 Feb 3.
PubMed 39904103Dolny DG, Collins MG, Wilson T, Germann ML, Davis HP. Validity of lower extremity strength and power utilizing a new closed chain dynamometer. Med Sci Sports Exerc. 2001 Jan;33(1):171-5. doi: 10.1097/00005768-200101000-00026.
PubMed 11194105Kim Heon-tae, Moon Jun-bae, Ryu Seung-ho, and Kang Min-soo. Validity study of the Korean version of the International Physical Activity Questionnaire (IPAQ): Verification of construct-related validity. Korean Journal of Physical Education No. 2017;56
Gajdosik RL, Bohannon RW. Clinical measurement of range of motion. Review of goniometry emphasizing reliability and validity. Phys Ther. 1987 Dec;67(12):1867-72. doi: 10.1093/ptj/67.12.1867.
PubMed 3685114Cuthbert SC, Goodheart GJ Jr. On the reliability and validity of manual muscle testing: a literature review. Chiropr Osteopat. 2007 Mar 6;15:4. doi: 10.1186/1746-1340-15-4.
PubMed 17341308Mehrholz J, Wagner K, Rutte K, Meissner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007 Oct;88(10):1314-9. doi: 10.1016/j.apmr.2007.06.764.
PubMed 17908575Setoguchi D, Kinoshita K, Kamada S, Sakamoto T, Kise N, Kotani N, Goto K, Shiota E, Inoue T, Yamamoto T. Hybrid Assistive Limb improves restricted hip extension after total hip arthroplasty. Assist Technol. 2022 Jan 2;34(1):112-120. doi: 10.1080/10400435.2020.1712498. Epub 2020 Jan 22.
PubMed 31909703Li J, Wu T, Xu Z, Gu X. A pilot study of post-total knee replacement gait rehabilitation using lower limbs robot-assisted training system. Eur J Orthop Surg Traumatol. 2014 Feb;24(2):203-8. doi: 10.1007/s00590-012-1159-9. Epub 2013 Jan 9.
PubMed 23412304Rohner E, Mayfarth A, Sternitzke C, Layher F, Scheidig A, Gross HM, Matziolis G, Bohle S, Sander K. Mobile Robot-Based Gait Training after Total Hip Arthroplasty (THA) Improves Walking in Biomechanical Gait Analysis. J Clin Med. 2021 May 29;10(11):2416. doi: 10.3390/jcm10112416.
PubMed 34072524Koseki K, Mutsuzaki H, Yoshikawa K, Iwai K, Hashizume Y, Nakazawa R, Kohno Y. Early Recovery of Walking Ability in Patients After Total Knee Arthroplasty Using a Hip-Wearable Exoskeleton Robot: A Case-Controlled Clinical Trial. Geriatr Orthop Surg Rehabil. 2021 Jun 28;12:21514593211027675. doi: 10.1177/21514593211027675. eCollection 2021.
PubMed 34262793Kirkley A, Webster-Bogaert S, Litchfield R, Amendola A, MacDonald S, McCalden R, Fowler P. The effect of bracing on varus gonarthrosis. J Bone Joint Surg Am. 1999 Apr;81(4):539-48. doi: 10.2106/00004623-199904000-00012.
PubMed 10225800Pham T, Maillefert JF, Hudry C, Kieffert P, Bourgeois P, Lechevalier D, Dougados M. Laterally elevated wedged insoles in the treatment of medial knee osteoarthritis. A two-year prospective randomized controlled study. Osteoarthritis Cartilage. 2004 Jan;12(1):46-55. doi: 10.1016/j.joca.2003.08.011.
PubMed 14697682
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07147530
- Acronym / sponsor ID
- 9-2025-0018
- Conditions
- Hip Disease
- Keywords
- Rehabilitation, Gait, Wearable robot, Hip joint disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 6 Apr 2026 (estimated)
- Study completion
- 6 Apr 2026 (estimated)
- First posted
- 29 Aug 2025 (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.
Gait is an essential daily activity performed through the complex coordination of the central and peripheral nervous systems and the musculoskeletal system. Gait disorders can negatively affect quality of life, increase the risk of falls, decrease the ability to perform daily activities, and limit physical activity. Various musculoskeletal diseases can cause gait impairment, with hip osteoarthritis and osteonecrosis of the femoral head (ONFH) being the most representative conditions.
Various interventions can be attempted during the early stages of hip joint disease progression. However, improvement in symptoms does not necessarily indicate a halt in disease progression. As the condition advances in most patients, thinning of the full-thickness hip cartilage or collapse of the femoral head occurs, leading to restricted hip range of motion, weakness of the lower limb muscles and functional deterioration, resulting in the need for total hip arthroplasty.
THA offers significant improvements in pain relief and function, regardless of the patient's preoperative status, and can reduce long-term healthcare costs. However, performing THA at an early stage with minimal functional improvement is not recommended. Postoperative complications, such as infections, aseptic loosening, and instability, are potential risks, with younger patients aged 45-64 showing higher revision surgery rates compared to those aged 65 and older. This highlights the need for new interventions that can delay the time to surgery while improving gait function and muscle strength.
Therefore, this study aims to explore the clinical feasibility of the Angel Suit H10 (Angelrobotics, Seoul, Korea) by assessing whether wearing the Electrically Powered Orthopedic Exercise Device improves gait function in patients with hip joint diseases, along with evaluating user satisfaction and device safety.
Detailed description
(1) Overview of study design This investigator-initiated exploratory study is a pilot study designed to evaluate the effectiveness and safety of the Electrically Powered Orthopedic Exercise Device by measuring and analyzing gait function and balance ability in patients with hip joint diseases under both non-wearing and wearing conditions.
(2) Experimental Group and Evaluation Procedures
- Participant Selection: This study includes a single test group with a total of 30 participants. The selection of participants for the electrically powered orthopedic exercise device and the overall study process will be conducted under the prescription and guidance of a rehabilitation medicine specialist, and supervised by assistants (physicians and occupational therapists). The examiner will collect clinical information and conduct a screening assessment for each participant.
- Evaluation Phase Without Device: After the screening test, participants undergo assessments of walking ability and balance without wearing the motorized orthopedic exercise device. A 10-minute rest period is provided between each assessment. If the participant wishes, additional rest time is allowed and recorded in the case report form. The assessments include the 10-Meter Walk Test, the 6-Minute Walk Test, the Timed Up and Go Test, and the Berg Balance Scale. These evaluations are conducted in the rehabilitation function testing room on the second floor of the facility under the supervision of the research team (physician and either a physical or occupational therapist).
- Pre-Adaptation Phase: After the evaluations without the device, a total of four adaptation sessions are conducted, during which the participant wears the device and performs short-distance walking within 10 meters. These sessions are designed to help the participant become familiar with the operation and wearing method of the H10 device. Appropriate device settings are configured for each participant to minimize any potential inexperience or anxiety during use. Participants must complete all four adaptation sessions, and each session should be conducted within a two-week interval.
- Evaluation Phase:
After completing all four adaptation sessions, participants undergo assessments of walking ability and balance while wearing the motorized orthopedic exercise device. A 10-minute rest period is provided between each assessment. If the participant wishes, additional rest time is allowed and recorded in the case report form. The assessments include the 10-Meter Walk Test, the 6-Minute Walk Test, the Timed Up and Go Test, and the Berg Balance Scale. These evaluations are conducted in the rehabilitation function testing room on the second floor of the facility under the supervision of the research team (physician and either a physical or occupational therapist). After the evaluations are completed, a usability and satisfaction survey regarding the motorized orthopedic exercise device is conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Researchers will compare non-wearing and wearing conditions of the electrically powered orthopedic exercise device walking speeds, spatiotemporal parameters, balance in participants and does not establish a control group.
| Arm | Type | Receives |
|---|---|---|
| Wearing conditions of Electrically Powered Orthopedic Exercise Device | Experimental | Device: Electrically Powered Orthopedic Exercise DeviceParticipants will undergo gait and balance function tests under both non-wearing and wearing conditions of the electrically powered orthopedic exercise device |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals aged 19 or older
- Individuals diagnosed with hip osteoarthritis of Kellgren-Lawrence (K-L) Grade 1-4
- Individuals diagnosed with avascular necrosis of the femoral head at Association Research Circulation Osseous(ARCO) Stage 1-4
- Individuals able to sit at the edge of a bed without assistance and stand for 10 seconds regardless of support
- Individuals who are Functional Ambulatory Category (FAC) score of 1-3
Key exclusion criteria (14 listed)
- Individuals who have contraindications for lower limb weight-bearing such as severe joint contractures, osteoporosis, or untreated fractures
- Individuals who have progressive or unstable brain diseases or neurological paralysis from stroke
- Individuals who have active infections or open wounds hindering device use
- Individuals who have significant leg length discrepancies
- Individuals who have severe deformities or contractures in the lower extremities
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 |
|---|---|---|
| Electrically Powered Orthopedic Exercise DeviceParticipants who pass the screening undergo an evaluation of gait function and balance ability without wearing the Electrically Powered Orthopedic Exercise Device. Afterward, the patient wears the motorized orthopedic exercise device for a total of four adaptation sessions. In each session, the patient performs short-distance walking within 10 meters while wearing the device to explore the appropriate assistive mode and level of support that match their physical condition. No evaluations are conducted while wearing the device during sessions 1, 2, and 3. After the 4th session, an evaluation identical to the one conducted without the device is performed while wearing it, and a satisfaction survey is conducted. | Device | Wearing conditions of Electrically Powered Orthopedic Exercise Device |
Primary outcome
10-Meter Walk Test
Time frame: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
Patients are instructed to walk 14 m, including 2 m at both ends for acceleration and deceleration, at their comfortable speed. Gait speed was calculated by dividing the 10m distance by the time taken.
9 secondary outcomes
Timed Up and Go (TUG) Test
Time frame: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
6-Minute Walk Test
Time frame: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
Berg balance scale (BBS)
Time frame: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
Spatiotemporal Parameters of Gait : Total Step Count
Time frame: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
Spatiotemporal Parameters of Gait : Cadence
Time frame: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
Spatiotemporal Parameters of Gait : Self-Selected Walking Speed
Time frame: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
Spatiotemporal Parameters of Gait : Distance
Time frame: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
Spatiotemporal Parameters of Gait : Stride Length
Time frame: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4
Satisfaction evaluation
Time frame: Upon completion of the end-point assessment conducted on the same day as session 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Background: PubMed 23023812Godi M, Franchignoni F, Caligari M, Giordano A, Turcato AM, Nardone A. Comparison of reliability, validity, and responsiveness of the mini-BESTest and Berg Balance Scale in patients with balance disorders. Phys Ther. 2013 Feb;93(2):158-67. doi: 10.2522/ptj.20120171. Epub 2012 Sep 27.
- Background: PubMed 3978515Guyatt GH, Sullivan MJ, Thompson PJ, Fallen EL, Pugsley SO, Taylor DW, Berman LB. The 6-minute walk: a new measure of exercise capacity in patients with chronic heart failure. Can Med Assoc J. 1985 Apr 15;132(8):919-23.
- Background: PubMed 26456063Hwang R, Morris NR, Mandrusiak A, Mudge A, Suna J, Adsett J, Russell T. Timed Up and Go Test: A Reliable and Valid Test in Patients With Chronic Heart Failure. J Card Fail. 2016 Aug;22(8):646-50. doi: 10.1016/j.cardfail.2015.09.018. Epub 2015 Oct 9.
- Background: PubMed 39904103Santos M, Zdravevski E, Albuquerque C, Coelho PJ, Pires IM. Ten Meter Walk Test for motor function assessment with technological devices based on lower members' movements: A systematic review. Comput Biol Med. 2025 Mar;187:109734. doi: 10.1016/j.compbiomed.2025.109734. Epub 2025 Feb 3.
- Background: PubMed 11194105Dolny DG, Collins MG, Wilson T, Germann ML, Davis HP. Validity of lower extremity strength and power utilizing a new closed chain dynamometer. Med Sci Sports Exerc. 2001 Jan;33(1):171-5. doi: 10.1097/00005768-200101000-00026.
- BackgroundKim Heon-tae, Moon Jun-bae, Ryu Seung-ho, and Kang Min-soo. Validity study of the Korean version of the International Physical Activity Questionnaire (IPAQ): Verification of construct-related validity. Korean Journal of Physical Education No. 2017;56
- Background: PubMed 3685114Gajdosik RL, Bohannon RW. Clinical measurement of range of motion. Review of goniometry emphasizing reliability and validity. Phys Ther. 1987 Dec;67(12):1867-72. doi: 10.1093/ptj/67.12.1867.
- Background: PubMed 17341308Cuthbert SC, Goodheart GJ Jr. On the reliability and validity of manual muscle testing: a literature review. Chiropr Osteopat. 2007 Mar 6;15:4. doi: 10.1186/1746-1340-15-4.
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- Individual participant dataSharing planned: No
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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.
Na Young Kim, MD, PhD principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Electrically Powered Orthopedic Exercise Device in people with Hip Disease, run by Yonsei University at 1 site in South Korea.
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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Na Young Kim, MD, PhD (+82 010 9127 4482, kny8452@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-Meter Walk Test (time frame: A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07147530, which also lists 38 linked publications.
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 29 Aug 2025.