Trial Outcomes & Findings for VR-based Rehabilitation in the Treatment and Prevention of Sarcopenia of Older Residents (NCT NCT03809104)
NCT ID: NCT03809104
Last Updated: 2020-01-21
Results Overview
The measurements of the HGS were determined by means of the JAMAR-Dynamometer. The forearm was held in neutral position and the wrist at a 0 to 30° extension. The instrument was held freely: neither the hand nor the forearm was allowed to rest on a surface. Three measurements were done and recorded as the average of the three measurements and the participants rested for 1 minute in between measurements. The change was calculated by the data of the third month minus the baseline data.
COMPLETED
NA
43 participants
3 months after the intervention of the virtual reality-based rehabilitation programs
2020-01-21
Participant Flow
Older adults aged more than 60 and lived in the nursing home or went to daycare center regularly in rural southern Taiwan were recruited for screening.All the residents with sufficient cognitive function and physical fitness to perform training that lasts for 30 minutes and meeting the criteria of sarcopenia by AWGS.
A total of 43 participants were recruited for VR-REH. Among them, 40 patients completed the study and 3 patients withdrew during the study period (2 dropped out during the visit at 4 weeks due to hospitalization and 1 withdrew at 8 weeks due to case-closed from daycare center).
Participant milestones
| Measure |
Elderly With Sarcopenia
Virtual reality-based rehabilitation programs
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.
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|---|---|
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Overall Study
STARTED
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43
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Overall Study
COMPLETED
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40
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
Elderly With Sarcopenia
Virtual reality-based rehabilitation programs
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.
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Overall Study
Withdrawal by Subject
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3
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Baseline Characteristics
VR-based Rehabilitation in the Treatment and Prevention of Sarcopenia of Older Residents
Baseline characteristics by cohort
| Measure |
Elderly With Sarcopenia
n=40 Participants
Virtual reality-based rehabilitation programs
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.
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Age, Continuous
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74.57 years
STANDARD_DEVIATION 12.83 • n=5 Participants
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Sex: Female, Male
Female
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26 Participants
n=5 Participants
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Sex: Female, Male
Male
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14 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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40 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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0 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
Taiwan
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40 participants
n=5 Participants
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Height
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156.97 cm
STANDARD_DEVIATION 8.76 • n=5 Participants
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Weight
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58.74 kg
STANDARD_DEVIATION 10.89 • n=5 Participants
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PRIMARY outcome
Timeframe: 3 months after the intervention of the virtual reality-based rehabilitation programsThe measurements of the HGS were determined by means of the JAMAR-Dynamometer. The forearm was held in neutral position and the wrist at a 0 to 30° extension. The instrument was held freely: neither the hand nor the forearm was allowed to rest on a surface. Three measurements were done and recorded as the average of the three measurements and the participants rested for 1 minute in between measurements. The change was calculated by the data of the third month minus the baseline data.
Outcome measures
| Measure |
Elderly With Sarcopenia
n=40 Participants
Virtual reality-based rehabilitation programs
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.
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Change of Hand-grip Strength of the Dominant Hand Between the Third Month and the Baseline
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5.02 kg
Standard Deviation 1.25
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PRIMARY outcome
Timeframe: 3 months after the intervention of the virtual reality-based rehabilitation programsTiming starts after the patient starts walking and stops at the point when a patient reaches a distance of 6 meters. The gait speed in measured twice and the final measurement is the average of the two scores. The patient is allowed to rest for 10 minutes in between measurement. The change was calculated by the data of the third month minus the baseline data.
Outcome measures
| Measure |
Elderly With Sarcopenia
n=40 Participants
Virtual reality-based rehabilitation programs
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.
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Change of Walking Speed Between the Third Month and the Baseline
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0.2 meter/second
Standard Deviation 0.06
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PRIMARY outcome
Timeframe: 3 months after the intervention of the virtual reality-based rehabilitation programsAppendicular skeletal muscle mass (ASM) is defined by the sum of the lean soft tissue mass of four limbs. Appendicular skeletal muscle mass index (ASMI) is defined as ASM (kg) divided by squared height (m).The body composition was measured via bio-electrical impedance analysis by Omron KARADA Scan Body Composition \& Scale (HBF-701). A participant was considered to have low muscle mass if his or her ASMI was below -2 standard deviations of the reference defined in previous studies from Taiwan (6.76 kg/m2 for men and 5.28 kg/m2 for women). Participants with ASMI in the lowest 20% of the sex-specific distribution were considered to have low muscle mass, too. Increased of ASMI after virtual reality-based rehabilitation programs is considered to be better. The change was calculated by the data of the third month minus the baseline data.
Outcome measures
| Measure |
Elderly With Sarcopenia
n=40 Participants
Virtual reality-based rehabilitation programs
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.
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Change of Appendicular Skeletal Muscle Mass Between the Third Month and the Baseline
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0.21 kg/meter square
Standard Deviation 0.06
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SECONDARY outcome
Timeframe: baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programsUse goniometry for range of motion measurement. The joints measured include shoulder, elbow, and wrist of the dominant side.
Outcome measures
| Measure |
Elderly With Sarcopenia
n=40 Participants
Virtual reality-based rehabilitation programs
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.
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Range of Motions in Dominant Upper Extremity
shoulder flexion (baseline)
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130.36 degree
Standard Deviation 14.32
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Range of Motions in Dominant Upper Extremity
shoulder flexion (the first month)
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139.07 degree
Standard Deviation 11.01
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Range of Motions in Dominant Upper Extremity
shoulder flexion (the second month)
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143.07 degree
Standard Deviation 8.43
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Range of Motions in Dominant Upper Extremity
shoulder external rotation (the second month)
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77.36 degree
Standard Deviation 4.68
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Range of Motions in Dominant Upper Extremity
shoulder external rotation (the third month)
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79.50 degree
Standard Deviation 3.70
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Range of Motions in Dominant Upper Extremity
shoulder abduction (baseline)
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128.79 degree
Standard Deviation 25.61
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Range of Motions in Dominant Upper Extremity
shoulder abduction (the first month)
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130.71 degree
Standard Deviation 15.70
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Range of Motions in Dominant Upper Extremity
wrist flexion (the first month)
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56.36 degree
Standard Deviation 8.82
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Range of Motions in Dominant Upper Extremity
shoulder flexion (the third month)
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149.79 degree
Standard Deviation 8.70
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Range of Motions in Dominant Upper Extremity
shoulder external rotation (baseline)
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71.68 degree
Standard Deviation 10.64
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Range of Motions in Dominant Upper Extremity
shoulder external rotation (the first month)
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75.50 degree
Standard Deviation 5.95
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Range of Motions in Dominant Upper Extremity
shoulder abduction (the second month)
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138.21 degree
Standard Deviation 9.94
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Range of Motions in Dominant Upper Extremity
shoulder abduction (the third month)
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141.93 degree
Standard Deviation 9.82
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Range of Motions in Dominant Upper Extremity
elbow flexion (baseline)
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120.29 degree
Standard Deviation 10.89
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Range of Motions in Dominant Upper Extremity
elbow flexion (the first month)
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117.29 degree
Standard Deviation 7.57
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Range of Motions in Dominant Upper Extremity
elbow flexion (the secondt month)
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118.79 degree
Standard Deviation 8.54
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Range of Motions in Dominant Upper Extremity
elbow flexion (the third month)
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119.93 degree
Standard Deviation 6.88
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Range of Motions in Dominant Upper Extremity
elbow extension (baseline)
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3.71 degree
Standard Deviation 2.77
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Range of Motions in Dominant Upper Extremity
elbow extension (the first month)
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3.43 degree
Standard Deviation 1.55
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Range of Motions in Dominant Upper Extremity
elbow extension (the second month)
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3.79 degree
Standard Deviation 1.12
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Range of Motions in Dominant Upper Extremity
elbow extension (the third month)
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4.64 degree
Standard Deviation 0.63
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Range of Motions in Dominant Upper Extremity
elbow supination (baseline)
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56.07 degree
Standard Deviation 15.27
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Range of Motions in Dominant Upper Extremity
elbow supination (the first month)
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56.64 degree
Standard Deviation 9.95
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Range of Motions in Dominant Upper Extremity
elbow supination (the second month)
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59.14 degree
Standard Deviation 9.24
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Range of Motions in Dominant Upper Extremity
elbow supination (the third month
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66.86 degree
Standard Deviation 9.45
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Range of Motions in Dominant Upper Extremity
elbow pronation (baseline)
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59.43 degree
Standard Deviation 18.33
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Range of Motions in Dominant Upper Extremity
elbow pronation (the first month)
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60.43 degree
Standard Deviation 13.23
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Range of Motions in Dominant Upper Extremity
elbow pronation (the second month)
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63.21 degree
Standard Deviation 13.10
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Range of Motions in Dominant Upper Extremity
elbow pronation (the third month)
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69.21 degree
Standard Deviation 9.37
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Range of Motions in Dominant Upper Extremity
wrist flexion (baseline)
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51.86 degree
Standard Deviation 9.80
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Range of Motions in Dominant Upper Extremity
wrist flexion (the second month)
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62.07 degree
Standard Deviation 5.90
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Range of Motions in Dominant Upper Extremity
wrist flexion (the third month)
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66.71 degree
Standard Deviation 4.68
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Range of Motions in Dominant Upper Extremity
wrist extension (baseline)
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52.50 degree
Standard Deviation 10.90
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Range of Motions in Dominant Upper Extremity
wrist extension (the first month)
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58.64 degree
Standard Deviation 12.60
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Range of Motions in Dominant Upper Extremity
wrist extension (the second month)
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65.93 degree
Standard Deviation 9.04
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Range of Motions in Dominant Upper Extremity
wrist extension (the third month)
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69.86 degree
Standard Deviation 7.49
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SECONDARY outcome
Timeframe: baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programsThis research uses MicroFET3 to measure the the maximal voluntary isometric contraction of the biceps and triceps. Measurements are taken 2 times and the results are averaged. MicroFET3 is a electronic hand-held dynamometer that can measure muscle strength. The range of muscle testing of the device ranges from 0-150 lbs force.(Digital Dynamometer and Inclinometer \| MicroFET®3) .
Outcome measures
| Measure |
Elderly With Sarcopenia
n=40 Participants
Virtual reality-based rehabilitation programs
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.
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Strength of Biceps Brachii and Triceps Brachii of the Dominant Upper Extremity
Strength of biceps brachii muscle (baseline)
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5.03 kg
Standard Deviation 1.31
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Strength of Biceps Brachii and Triceps Brachii of the Dominant Upper Extremity
Strength of biceps brachii muscle (the 3rd month)
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6.44 kg
Standard Deviation 1.21
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Strength of Biceps Brachii and Triceps Brachii of the Dominant Upper Extremity
Strength of triceps brachii muscle (the 2nd month)
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5.75 kg
Standard Deviation 1.12
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Strength of Biceps Brachii and Triceps Brachii of the Dominant Upper Extremity
Strength of triceps brachii muscle (the 3rd month)
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6.15 kg
Standard Deviation 1.27
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Strength of Biceps Brachii and Triceps Brachii of the Dominant Upper Extremity
Strength of biceps brachii muscle (the 1st month)
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5.48 kg
Standard Deviation 1.28
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Strength of Biceps Brachii and Triceps Brachii of the Dominant Upper Extremity
Strength of biceps brachii muscle (the 2nd month)
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5.80 kg
Standard Deviation 1.22
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Strength of Biceps Brachii and Triceps Brachii of the Dominant Upper Extremity
Strength of triceps brachii muscle (baseline)
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5.06 kg
Standard Deviation 1.20
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Strength of Biceps Brachii and Triceps Brachii of the Dominant Upper Extremity
Strength of triceps brachii muscle (the 1st month)
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5.55 kg
Standard Deviation 1.35
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SECONDARY outcome
Timeframe: baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programsThe Box and Block Test (BBT) can measure the unilateral gross manual dexterity. The set up of the BBT test includes a wooden box with 150 wooden blocks inside. The wooden box is divided into two compartments. One filled with blocks, and the other is empty.During this test, the patient is seated upright in a chair and needs to transfer the wooden blocks, one by one, from one compartment to the other. The patient is scored based on the number of blocks he or she can transferred from one compartment to the other in 60 seconds.
Outcome measures
| Measure |
Elderly With Sarcopenia
n=40 Participants
Virtual reality-based rehabilitation programs
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.
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Box and Block Test
number (baseline)
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26.86 boxes
Standard Deviation 12.63
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Box and Block Test
number (the first month)
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34.14 boxes
Standard Deviation 13.12
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Box and Block Test
number (the third month)
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37.57 boxes
Standard Deviation 12.91
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Box and Block Test
number (the second month)
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36.04 boxes
Standard Deviation 9.31
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Adverse Events
Elderly With Sarcopenia
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Elderly With Sarcopenia
n=40 participants at risk
Virtual reality-based rehabilitation programs
Virtual reality-based rehabilitation programs: A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.
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|---|---|
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Ear and labyrinth disorders
light-headedness
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12.5%
5/40 • Number of events 5 • 3 months
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Eye disorders
sore eyes
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7.5%
3/40 • Number of events 3 • 3 months
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Additional Information
Ms. Chia-Yu Wei
Ci-Shan Hospital, Health and Welfare of Minister, Taiwan
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60