SarcopeniaNCT07830472
Lower-Limb Rehabilitation Robot Training for Sarcopenia
A study testing Lower-Limb Rehabilitation Robot Training and Nutrition Education in people with Sarcopenia, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Lower-Limb Rehabilitation Robot Training and Nutrition Education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Mar 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
SHENG-WEN SU contact
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, Taipei City, 11031
Sheng-Wen Su, PhD, +886-2-2874-3415 ext. 3244, 10154susw@gmail.com
About this study
Official title: Research on Lower Limb Rehabilitation Robots 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:
- Does lower-limb rehabilitation robot training improve muscle mass and body composition?
- Does the training improve muscle strength, walking ability, balance, and physical function?
Read more
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Lower-Limb Rehabilitation Robot Training, Nutrition Education, Usual Care Exercise
- Keywords
- Robot-Assisted Rehabilitation, High-Intensity Training, Nutrition Education, Physical Function, Walking Ability
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower-Limb Rehabilitation Robot TrainingDevice
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 EducationBehavioural
Participants will receive nutrition education as part of the study intervention.
Usual Care ExerciseBehavioural
Participants in the control group will receive usual care exercise without additional lower-limb rehabilitation robot training.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Care Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 5, and Week 8
Secondary outcomes (7)
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.
Measured: Baseline, Week 5, and Week 8
Functional Ambulation Category
Walking ability will be assessed using the Functional Ambulation Category (FAC).
Measured: Baseline, Week 5, and Week 8
Short Physical Performance Battery
Physical performance and balance will be assessed using the Short Physical Performance Battery (SPPB).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline, Week 5, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start9 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- HIWIN Technologies Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830472
- Sponsor's protocol ID
- A-114-011-T
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Lower Limb Rehabilitation Robots for Sarcopenia
- ClinicalTrials.gov ID
- NCT07830472
- Acronym / sponsor ID
- A-114-011-T
- Conditions
- Sarcopenia
- Keywords
- Robot-Assisted Rehabilitation, High-Intensity Training, Nutrition Education, Physical Function, Walking Ability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Collaborators
- HIWIN Technologies Corporation
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Robot-Assisted Training Group | Experimental | Device: Lower-Limb Rehabilitation Robot Training, Behavioral: Nutrition EducationParticipants 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. |
| Usual Care Group | Active comparator | Behavioral: Usual Care ExerciseParticipants will receive usual care, including exercise and nutrition education, without additional lower-limb rehabilitation robot training. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower-Limb Rehabilitation Robot TrainingParticipants 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. | Device | Robot-Assisted Training Group |
| Nutrition EducationParticipants will receive nutrition education as part of the study intervention. | Behavioural | Robot-Assisted Training Group |
| Usual Care ExerciseParticipants in the control group will receive usual care exercise without additional lower-limb rehabilitation robot training. | Behavioural | Usual Care Group |
Primary outcome
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.
7 secondary outcomes
Five-Time Sit-to-Stand Test
Time frame: Baseline, Week 5, and Week 8
Functional Ambulation Category
Time frame: Baseline, Week 5, and Week 8
Short Physical Performance Battery
Time frame: Baseline, Week 5, and Week 8
EQ-5D Health-Related Quality of Life
Time frame: Baseline, Week 5, and Week 8
Lower Extremity Functional Scale (LEFS)
Time frame: Baseline, Week 5, and Week 8
Sarcopenia Health Literacy
Time frame: Baseline, Week 5, and Week 8
Sarcopenia-Specific Quality of Life
Time frame: Baseline, Week 5, and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SHENG-WEN SU contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower-Limb Rehabilitation Robot Training and Nutrition Education in people with Sarcopenia, run by Taipei Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SHENG-WEN SU, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal Muscle Mass Index (SMI) (time frame: Baseline, Week 5, and Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.