Lower-Limb Rehabilitation Robot Training for Sarcopenia
ConditionSarcopenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorTaipei Medical University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Lower-Limb Rehabilitation Robot Training
DeviceParticipants 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
BehavioralParticipants will receive nutrition education as part of the study intervention.
Usual Care Exercise
BehavioralParticipants in the control group will receive usual care exercise without additional lower-limb rehabilitation robot training.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Robot-Assisted Training GroupExperimental treatment 2 interventions
Group B: Usual Care GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 82
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 83
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 8Secondary outcomes
1
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 82
Functional Ambulation Category
Walking ability will be assessed using the Functional Ambulation Category (FAC).
Time frame
Baseline, Week 5, and Week 83
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 84
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 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Taipei Medical University Hospital
Lead sponsor
HIWIN Technologies Corporation
Collaborator
Source ClinicalTrials.gov