Research on Lower Limb Rehabilitation Robots for Sarcopenia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Skeletal Muscle Mass Index (SMI)
Study Overview
Brief Summary
The goal of this clinical trial is to learn whether lower-limb rehabilitation robot training combined with nutrition education can improve muscle mass and physical function in adults aged 60 years or older with sarcopenia. The main questions it aims to answer are:
- Does lower-limb rehabilitation robot training improve muscle mass and body composition?
- Does the training improve muscle strength, walking ability, balance, and physical function?
Researchers will compare participants who receive lower-limb rehabilitation robot training plus nutrition education with participants who receive usual care, including exercise and nutrition education, to see whether adding robot-assisted training provides additional benefits.
Participants will:
- Complete assessments before the intervention, around week 5, and after week 8.
- Receive either 8 weeks of lower-limb rehabilitation robot training using the MRG-P110 plus nutrition education, or usual care including exercise and nutrition education.
- Complete assessments of body composition, muscle strength, walking ability, balance, and health-related quality of life.
Detailed Description
Sarcopenia is associated with loss of muscle mass, reduced muscle strength, impaired physical function, and increased risks of falls and disability in older adults. Conventional exercise and nutritional interventions often require longer treatment periods to achieve measurable improvements. Lower-limb rehabilitation robots may provide intensive and repetitive gait training over a shorter period, while nutrition education may support maintenance or improvement of muscle health.
This study uses a two-arm, parallel, quasi-experimental design to evaluate the additional effects of lower-limb rehabilitation robot training when added to nutrition education and usual care in adults with sarcopenia. Participants in both groups will undergo assessments at baseline, mid-intervention, and post-intervention. The study is intended to determine whether this combined approach can provide clinically meaningful improvements in muscle-related and functional outcomes and to assess its feasibility for clinical rehabilitation practice.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 60 years or older.
- •Meets the diagnostic criteria for sarcopenia according to the Asian Working Group for Sarcopenia (AWGS).
- •Conscious and able to understand and follow movement instructions.
- •Able to stand for at least 1 minute.
- •Physically able to tolerate lower-limb rehabilitation robot training.
Exclusion Criteria
- •Body weight greater than 135 kg.
- •Height less than 145 cm or greater than 190 cm, resulting in incompatibility with the exoskeleton.
- •Presence of an unhealed fracture.
- •Joint contracture or excessive lower-limb muscle tone that prevents participation in robotic training.
Arms & Interventions
Robot-Assisted Training Group
Participants will receive lower-limb rehabilitation robot training using the MRG-P110 for 8 weeks, three sessions per week, 30 minutes per session, for a total of 24 sessions. Nutrition education will be provided after each training session.
Intervention: Lower-Limb Rehabilitation Robot Training (Device)
Robot-Assisted Training Group
Participants will receive lower-limb rehabilitation robot training using the MRG-P110 for 8 weeks, three sessions per week, 30 minutes per session, for a total of 24 sessions. Nutrition education will be provided after each training session.
Intervention: Nutrition Education (Behavioral)
Usual Care Group
Participants will receive usual care, including exercise and nutrition education, without additional lower-limb rehabilitation robot training.
Intervention: Usual Care Exercise (Behavioral)
Outcomes
Primary Outcomes
Skeletal Muscle Mass Index (SMI)
Time Frame: Baseline, Week 5, and Week 8
Skeletal muscle mass index (SMI) will be measured in kg/m². Lower values indicate lower skeletal muscle mass. According to the criteria used in this study, low muscle mass is defined as SMI ≤7.0 kg/m² in men and ≤5.7 kg/m² in women.
Handgrip Strength
Time Frame: Baseline, Week 5, and Week 8
Handgrip strength of the dominant hand will be measured in kilograms (kg). Higher values indicate greater muscle strength. According to the criteria used in this study, low muscle strength is defined as \<28 kg in men and \<18 kg in women.
4-Meter Gait Speed
Time Frame: Baseline, Week 5, and Week 8
Gait speed will be assessed using the 4-meter walk test and reported in meters per second (m/s). Higher values indicate better walking performance. According to the criteria used in this study, a gait speed \<1.0 m/s indicates impaired physical performance.
Secondary Outcomes
- Five-Time Sit-to-Stand Test(Baseline, Week 5, and Week 8)
- Functional Ambulation Category(Baseline, Week 5, and Week 8)
- Short Physical Performance Battery(Baseline, Week 5, and Week 8)
- EQ-5D Health-Related Quality of Life(Baseline, Week 5, and Week 8)
- Lower Extremity Functional Scale (LEFS)(Baseline, Week 5, and Week 8)
- Sarcopenia Health Literacy(Baseline, Week 5, and Week 8)
- Sarcopenia-Specific Quality of Life(Baseline, Week 5, and Week 8)