Clinical trial NCT06543888: Effects of Passive Lower-limb Exoskeleton-assisted Training on Motor and Daily Function Improvements in Older Adults
Official title: Effects of Passive Lower-limb Exoskeleton-assisted Training on Motor and Daily Function Improvements in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multidomain Intervention
Keywords: aging
motor function,
gait,
exoskeleton
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: According to National Development Council estimation, Taiwan is about to enter a super-aged society in 2025, and health promotion for the elderly are critical issues nowadays. The age-related decline in motor function will further affect participation in activities of daily living. In addition to conventional rehabilitation training, robot-assisted training has gained acceptance in clinical rehabilitation. However, robot-assisted trainings were mostly used for motor recovery in patients with neurological disorders, and has not yet been applied to motor function training in community dwelling older adults. This study will examine the effect of passive exoskeleton-assisted gait training on motor function, daily function and self- efficacy in community dwelling older adults, so as to achieve health promotion and develop a new training approach. The purpose of this study will be to determine the comparative effects of passive exoskeleton-assisted gait training and conventional gait training on motor and daily function improvements in older adults.


Eligibility criteria: Inclusion Criteria:

1. age ≧ 60
2. normal functional range of motion (within functional limits) in trunk, and leg joints
3. ability to walk continuously for 10 minutes with or without an assistive device
4. Mini Mental State Exam (MMSE) score \> 24, indicating no serious cognitive impairment

Exclusion Criteria:

1. histories of neurological diseases such as dementia, Parkinson\&#39;s disease, and peripheral polyneuropathy
2. recent lower leg injury (6 months) or surgery (1 year) based on self-report
3. taking any over-the-counter drugs, prescription medications, or any substance that may affect gait
4. difficulties in following and understanding instructions
5. enroll in other rehabilitation or drug studies simultaneously -

Primary outcomes:
measure: Change scores of Five Times Sit to Stand Test (FTSST)
timeFrame: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]
measure: Change scores of Timed Up and Go Test (TUG)
timeFrame: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]
measure: Change scores of 10-meter walk test (10MWT)
timeFrame: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]
measure: Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
timeFrame: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]
measure: Change scores of Daily Living Self-Efficacy Scale (DLSES)
timeFrame: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]
measure: Change scores of Functional Abilities Confidence Scale (FACS)
timeFrame: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]
measure: Change scores of Mini-Mental State Examination (MMSE)
timeFrame: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memotial Hospital
state: Guishan
Study officials:
References: