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

(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.

Inclusion criteria

• 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)

Exclusion criteria

• 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