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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 10-Meter Walk Test
研究概览
简要总结
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.
详细描述
(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. 2. 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). 3. Pre-Adaptation Phase:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
- •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
结局指标
主要结局
10-Meter Walk Test
时间窗: 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.
次要结局
- Berg balance scale (BBS)(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(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(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)
- Timed Up and Go (TUG) Test(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(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(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(Upon completion of the end-point assessment conducted on the same day as session 4)
- 6-Minute Walk Test(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(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)