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

Chang Gung Medical Foundation logo

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

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

Trial contacts and locations

1

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Central trial contact

Yen-Wei Chen, PhD; Ching-yi Wu, ScD

Data sourced from clinicaltrials.gov

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