An interventional study of Lower-Limb Rehabilitation Robot Training and Nutrition Education in Sarcopenia, sponsored by Taipei Medical University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Taipei Medical University Hospital · Not applicable, Interventional, and Treatment
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:
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:
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.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 855 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Taipei Medical University Hospital is the lead sponsor of 64 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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.
Device: Lower-Limb Rehabilitation Robot Training · Behavioral: Nutrition Education
Participants will receive usual care, including exercise and nutrition education, without additional lower-limb rehabilitation robot training.
Behavioral: Usual Care Exercise
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. Training parameters will be individualized according to participant height and baseline walking speed. Step length will initially be set at 15% of height, and walking speed at 80% of baseline walking speed. Training intensity will be monitored using the Borg Rating of Perceived Exertion scale and maintained at 5-6.
Participants will receive nutrition education as part of the study intervention.
Participants in the control group will receive usual care exercise without additional lower-limb rehabilitation robot training.
Skeletal Muscle Mass Index (SMI)
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.
Time frame: Baseline, Week 5, and Week 8
Handgrip Strength
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.
Time frame: Baseline, Week 5, and Week 8
4-Meter Gait Speed
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.
Time frame: Baseline, Week 5, and Week 8
Five-Time Sit-to-Stand Test
The time required to complete five consecutive sit-to-stand movements will be recorded in seconds. A shorter completion time indicates better lower-limb functional performance.
Time frame: Baseline, Week 5, and Week 8
Functional Ambulation Category
Walking ability will be assessed using the Functional Ambulation Category (FAC).
Time frame: Baseline, Week 5, and Week 8
Short Physical Performance Battery
Physical performance and balance will be assessed using the Short Physical Performance Battery (SPPB).
Time frame: Baseline, Week 5, and Week 8
EQ-5D Health-Related Quality of Life
Health-related quality of life will be assessed using the EQ-5D questionnaire.
Time frame: Baseline, Week 5, and Week 8
Lower Extremity Functional Scale (LEFS)
Self-reported lower-extremity function will be assessed using the Lower Extremity Functional Scale (LEFS).
Time frame: Baseline, Week 5, and Week 8
Sarcopenia Health Literacy
Participants' knowledge and health literacy related to sarcopenia will be assessed using a sarcopenia health literacy questionnaire.
Time frame: Baseline, Week 5, and Week 8
Sarcopenia-Specific Quality of Life
Sarcopenia-specific quality of life will be assessed using the Traditional Chinese short-form sarcopenia quality-of-life questionnaire.
Time frame: Baseline, Week 5, and Week 8
Plan to share: No — Individual participant data are not planned to be shared because no data-sharing arrangement has been established for this study, and participant confidentiality will be maintained.
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Taipei Medical University Hospital