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

NCT ID: NCT06543888

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2027-03-17

Brief Summary

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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.

Detailed Description

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Conditions

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Multidomain Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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passive exoskeleton- assisted gait training programs

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).

Group Type EXPERIMENTAL

passive exoskeleton- assisted gait training programs

Intervention Type BEHAVIORAL

Participants will wear an exoskeleton during the training. Each 30-minute Passive exoskeleton-assisted gait training session include range of motion exercise, movement facilitation, strengthening exercise, coordination exercise, and task-oriented training for activities of daily living

conventional gait training programs

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

Group Type ACTIVE_COMPARATOR

Conventional gait training

Intervention Type BEHAVIORAL

Each 30-minute conventional gait training session include range of motion exercise, movement facilitation, strengthening exercise, coordination exercise, and task-oriented training for activities of daily living.

Interventions

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passive exoskeleton- assisted gait training programs

Participants will wear an exoskeleton during the training. Each 30-minute Passive exoskeleton-assisted gait training session include range of motion exercise, movement facilitation, strengthening exercise, coordination exercise, and task-oriented training for activities of daily living

Intervention Type BEHAVIORAL

Conventional gait training

Each 30-minute conventional gait training session include range of motion exercise, movement facilitation, strengthening exercise, coordination exercise, and task-oriented training for activities of daily living.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 -
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memotial Hospital

Taoyuan District, Guishan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yen-Wei Chen, PhD

Role: CONTACT

+886-4-23323456 ext. 48053

Ching-yi Wu, ScD

Role: CONTACT

+886-3-2118800 ext. 5761

Facility Contacts

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Ching-Yi Wu, ScD

Role: primary

+886-3-2118800 ext. 5761

Other Identifiers

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202302129B0

Identifier Type: -

Identifier Source: org_study_id

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