Multidomain InterventionNCT06543888
Effects of Passive Lower-limb Exoskeleton-assisted Training on Motor and Daily Function Improvements in Older Adults
A study testing passive exoskeleton- assisted gait training programs and Conventional gait training in people with Multidomain Intervention, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multidomain Intervention
- What is being tested?
- passive exoskeleton- assisted gait training programs and Conventional gait training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2024to 17 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memotial Hospital
Taoyuan, Guishan, 333
Ching-Yi Wu, ScD, +886-3-2118800 ext. 5761, cywu@mail.cgu.edu.tw
Yen-Wei Chen,, PhD
About this study
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.
- Conditions
- Multidomain Intervention
- Being tested
- passive exoskeleton- assisted gait training programs, Conventional gait training
- Keywords
- aging, motor function,, gait,, exoskeleton
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive exoskeleton- assisted gait training programsBehavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| passive exoskeleton- assisted gait training programs | Experimental | 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). Receives: Behavioral: passive exoskeleton- assisted gait training programs |
| conventional gait training programs | Active comparator | Participants will receive 12 sessions of conventional gait training programs (30 min/session, 3 sessions/week for 4 consecutive weeks). Receives: Behavioral: Conventional gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of Five Times Sit to Stand Test (FTSST)
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.
Measured: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]
Change scores of Timed Up and Go Test (TUG)
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.
Measured: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]
Change scores of 10-meter walk test (10MWT)
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.
Measured: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]
Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
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.
Measured: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]
Change scores of Daily Living Self-Efficacy Scale (DLSES)
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.
Measured: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]
Change scores of Functional Abilities Confidence Scale (FACS)
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.
Measured: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]
Change scores of Mini-Mental State Examination (MMSE)
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.
Measured: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Aug 2024
- Primary completion17 Mar 2027 (estimated)
- Study completion17 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidomain InterventionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543888
- Sponsor's protocol ID
- 202302129B0
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Passive Lower-limb Exoskeleton-assisted Training on Motor and Daily Function Improvements in Older Adults
- ClinicalTrials.gov ID
- NCT06543888
- Acronym / sponsor ID
- 202302129B0
- Conditions
- Multidomain Intervention
- Keywords
- aging, motor function,, gait,, exoskeleton
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 17 Mar 2027 (estimated)
- Study completion
- 17 Mar 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| passive exoskeleton- assisted gait training programs | Experimental | Behavioral: passive exoskeleton- assisted gait training programsBehavioral: 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). |
| conventional gait training programs | Active comparator | Behavioral: Conventional gait trainingParticipants will receive 12 sessions of conventional gait training programs (30 min/session, 3 sessions/week for 4 consecutive weeks). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| passive exoskeleton- assisted gait training programsParticipants 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 | Behavioural | passive exoskeleton- assisted gait training programs |
| Conventional gait trainingEach 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. | Behavioural | conventional gait training programs |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing passive exoskeleton- assisted gait training programs and Conventional gait training in people with Multidomain Intervention, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yen-Wei Chen, PhD (+886-4-23323456 ext. 48053, ywc213@asia.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.