Lower-Limb Rehabilitation Robot Training for Sarcopenia

NCT07830472 | Recruiting

• 1 other identifier: A-114-011-T
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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:

1. 1.Does lower-limb rehabilitation robot training improve muscle mass and body composition?
2. 2.Does the training improve muscle strength, walking ability, balance, and physical function?
3. 3.Complete assessments before the intervention, around week 5, and after week 8.
4. 4.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.
5. 5.Complete assessments of body composition, muscle strength, walking ability, balance, and health-related quality of life.

Conditions

Sarcopenia

Keywords

Robot-Assisted Rehabilitation; High-Intensity Training; Nutrition Education; Physical Function; Walking Ability

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, Week 5, and Week 8

Secondary Outcomes (7)

• 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

Study Arms (2)

Robot-Assisted Training Group

EXPERIMENTAL

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

Usual Care Group

ACTIVE COMPARATOR

Participants will receive usual care, including exercise and nutrition education, without additional lower-limb rehabilitation robot training.

Behavioral: Usual Care Exercise

Interventions

Lower-Limb Rehabilitation Robot Training DEVICE

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.

Robot-Assisted Training Group

Nutrition Education BEHAVIORAL

Participants will receive nutrition education as part of the study intervention.

Robot-Assisted Training Group

Usual Care Exercise BEHAVIORAL

Participants in the control group will receive usual care exercise without additional lower-limb rehabilitation robot training.

Usual Care Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Hospital: lead
• HIWIN Technologies Corporation: collaborator

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taipei City, 11031, Taiwan

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

SHENG-WEN SU

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, parallel, non-randomized quasi-experimental study comparing lower-limb rehabilitation robot training plus nutrition education with usual care including exercise and nutrition education.

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)