None listed
Conditions
Interventions
Medical Device : Twenty participants will be randomly assigned to each of the Usual-Robot Group and the Robot-Usual Group.
The Usual-Robot Group will undergo 6 weeks of usual daily life without interv
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals who are 65 years of age or older, or those with gait impairment requiring assistance without physical contact during walking (Functional Ambulation Category [FAC] grade 3–4). 2. Individuals capable of independently walking more than 10 meters without the use of a walking aid (ambulatory without an assistive device). 3. Individuals who are willing to participate in 6 weeks of robot-assisted gait intervention. 4. Individuals who are able to receive information about this study, provide written informed consent prior to participation, and comply with the requirements of the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Individuals with medical conditions likely to worsen during study participation (e.g., uncontrolled hypertension [SBP =180 mmHg, DBP =110 mmHg], acute infectious diseases, etc.). 2. Individuals with severe heart failure or chronic obstructive pulmonary disease (COPD) presenting symptoms even during daily life, making walking difficult due to impaired cardiopulmonary function. 3. Individuals with musculoskeletal problems affecting physical function or motor ability (e.g., history of hip or knee arthroplasty, spinal fusion surgery within the past year). 4. Individuals with progressive neurological diseases characterized by rapid symptom deterioration (e.g., amyotrophic lateral sclerosis) that make it difficult to evaluate the effects of robot-assisted gait intervention. 5. Individuals unable to walk without assistance involving physical contact (FAC grade 1–2). 6. Individuals with skin disorders, severe spasticity, or other conditions that limit the use of a gait-assist robot 7. Individuals with reluctance or refusal to participate in robot-assisted gait training. 8. Individuals unable to understand the purpose of the clinical trial or to perform the study-related requirements. 9. Any other cases where the investigator judges that the individual’s condition makes participation in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SPPB (Short Physical Performance Battery) | — |
Secondary
| Measure | Time frame |
|---|---|
| x-ray(whole spine AP/lat, teleradiogram);Modified Nordic Musculoskeletal Questionairre;MOCA, PHQ-9, EQ-5D;Hand grip strength and lower extremity muscle strength;Bioelectrical Impedance Analysis;Dual-Energy X-ray Absorptiometry;Timed Up and Go Test;6 minute walk test;K-Physical Activity Scale for the Elderly;Daily step count;Korean Modified Barthel Index;Provocation test (if positive after screening, additional tests will be conducted);passive range of motion, assisted range of motion;Telephone follow-up survey (falls, pain, discomfort while wearing, usability);user log (by WIM application) | — |
Countries
Korea, Republic of
Contacts
Public ContactMINWOO HONG
Seoul National University Hospital
Outcome results
None listed