Effects of Passive Lower-limb Exoskeleton-assisted Training on Motor and Daily Function Improvements in Older Adults

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Multidomain Intervention

Treatments: Behavioral: Conventional gait training; Behavioral: passive exoskeleton- assisted gait training programs

Study type: Interventional

Funder types: Other

Identifiers

NCT06543888

202302129B0

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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'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 -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

passive exoskeleton- assisted gait training programs

Experimental group

Description:

Behavioral: passive exoskeleton- assisted gait training programs Participants will receive 12 sessions of passive exoskeleton-assisted gait training programs (30 min/session, 3 sessions/week for 4 consecutive weeks).

Treatment:

Behavioral: passive exoskeleton- assisted gait training programs

conventional gait training programs

Active Comparator group

Description:

Participants will receive 12 sessions of conventional gait training programs (30 min/session, 3 sessions/week for 4 consecutive weeks).

Treatment:

Behavioral: Conventional gait training