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NCT Number: NCT06543888

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memotial Hospital

Taoyuan, Guishan, 333, Taiwan

Location status: Recruiting

Location contact

Ching-Yi Wu, ScD

CONTACT

[email protected]

+886-3-2118800 ext. 5761

Yen-Wei Chen,, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

passive exoskeleton- assisted gait training programs

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

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.

Primary outcomes

  1. Change scores of Five Times Sit to Stand Test (FTSST)

    Time frame: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]

    The FTSST measures the time taken to stand five times from a sitting position as fast as possible, which is used to assess functional lower limb strength, balance control, and mobility in both healthy adults and those with pathologies. The FTSST has been proven to be safe and to have excellent reliability.

  2. Change scores of Timed Up and Go Test (TUG)

    Time frame: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]

    The TUG test assesses dynamic balance ability and mobility. The participants will be required to stand up from a chair, walk 3 m, turn around, walk back to the chair, and sit down. Three trials will be taken at each assessment, and the average of three trials will be documented. The time to complete the TUG test has been shown to be a good indicator to detect potential fallers in frail elderly individuals. The TUG is a reliable, valid, and easy-to-administer clinical tool.

  3. Change scores of 10-meter walk test (10MWT)

    Time frame: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]

    The 10MWT assesses walking speed in self-selected pace and fast walking pace, which can be employed to determine functional mobility. Two trials are administered at the participant's comfortable walking speed, followed by 2 trials at his/her fast walking speed. The 2 trials, for each speed, are averaged and the 2 gait speeds are documented in meters/second. The 10-meter walk test has demonstrated excellent

    reliability for comfortable and fastest gait speeds in healthy adults and other pathological populations.

  4. Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)

    Time frame: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]

    The NEADL is a measure of independence in 4 areas of daily life, including mobility, kitchen, domestic, and leisure activities. It includes 22 items, and each item is measured on a 4-point scale. The total score ranges from 0 to 66 and a higher score indicates better daily functional ability. The psychometric properties of the NEADL have been well established.

  5. Change scores of Daily Living Self-Efficacy Scale (DLSES)

    Time frame: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]

    The DLSES measures self-efficacy of daily functioning, including psychosocial functioning and activities of daily living. The scale consists of 12 items, and each item is measured on a 100-point scale with 10-unit intervals (0 = cannot do at all, 100 = highly certain can do). A higher score indicates higher level of self-efficacy. The DLSES is a psychometrically sound measure of self-efficacy in stroke survivors.

  6. Change scores of Functional Abilities Confidence Scale (FACS)

    Time frame: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]

    The FACS measures the degree of self-efficacy and confidence when the participants perform various movements and postures. It consists of 15 questions scoring from 0% (not confidence at all) to 100% (fully confidence). A higher score indicates higher confidence of performing the movements. The psychometric properties are good.

  7. Change scores of Mini-Mental State Examination (MMSE)

    Time frame: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]

    The MMSE a 30-point questionnaire that is the most commonly used brief screening tool for detecting cognitive impairment. Higher values represent a better cognitive functioning. The MMSE has good psychometric properties for identifying cognitive impairment.

Study contacts

Contact information is provided by the study sponsor or research team.

Ching-yi Wu, ScD

CONTACT

[email protected]

+886-3-2118800 ext. 5761

Yen-Wei Chen, PhD

CONTACT

[email protected]

+886-4-23323456 ext. 48053

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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