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NCT Number: NCT07830472

Lower-Limb Rehabilitation Robot Training for Sarcopenia

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. Does lower-limb rehabilitation robot training improve muscle mass and body composition? 2. 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:

1. Complete assessments before the intervention, around week 5, and after week 8. 2. 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. 3. Complete assessments of body composition, muscle strength, walking ability, balance, and health-related quality of life.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Hospital

Taipei, Taipei City, 11031, Taiwan

Location status: Recruiting

Location contact

Sheng-Wen Su, PhD

CONTACT

[email protected]

+886-2-2874-3415 ext. 3244

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Nutrition Education

Behavioral

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

Usual Care Exercise

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Five-Time Sit-to-Stand Test

    Time frame: Baseline, Week 5, and Week 8

    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.

  2. Functional Ambulation Category

    Time frame: Baseline, Week 5, and Week 8

    Walking ability will be assessed using the Functional Ambulation Category (FAC).

  3. Short Physical Performance Battery

    Time frame: Baseline, Week 5, and Week 8

    Physical performance and balance will be assessed using the Short Physical Performance Battery (SPPB).

  4. EQ-5D Health-Related Quality of Life

    Time frame: Baseline, Week 5, and Week 8

    Health-related quality of life will be assessed using the EQ-5D questionnaire.

  5. Lower Extremity Functional Scale (LEFS)

    Time frame: Baseline, Week 5, and Week 8

    Self-reported lower-extremity function will be assessed using the Lower Extremity Functional Scale (LEFS).

  6. Sarcopenia Health Literacy

    Time frame: Baseline, Week 5, and Week 8

    Participants' knowledge and health literacy related to sarcopenia will be assessed using a sarcopenia health literacy questionnaire.

  7. Sarcopenia-Specific Quality of Life

    Time frame: Baseline, Week 5, and Week 8

    Sarcopenia-specific quality of life will be assessed using the Traditional Chinese short-form sarcopenia quality-of-life questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

SHENG-WEN SU

CONTACT

Sponsors and collaborators

Lead sponsor

Taipei Medical University Hospital

Other

Collaborators

  • HIWIN Technologies Corporation

Registry information

Official study title

Research on Lower Limb Rehabilitation Robots for Sarcopenia

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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