Stroke SequelaeNCT05825144
Therapeutic Effects of Robotic Exoskeleton-Assisted Gait Re-habilitation and Predictive Factors of Significant Improvements in Stroke Patients
A study testing Robotic exoskeleton-assisted gait rehabilitation and Conventional rehabilitation in people with Stroke Sequelae, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Investigators aimed to examine the effectiveness of robotic exoskeleton-assisted gait training in stroke rehabilitation, and to determine predicting factors of significant improvements in post-stroke patients. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke Sequelae
- What is being tested?
- Robotic exoskeleton-assisted gait rehabilitation and Conventional rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged from 30 to 80 years
- hemiparesis due to ischemic or hemorrhagic stroke in the last 6 months
Who cannot join
- with a significant history of pain or injury of lower limbs that affected their walking ability,
- with cardiopulmonary diseases that prohibited exercise training
- with impaired cognitive function
- unable to complete the timed up-and-go test
- able to complete the timed up-and-go test in <20 seconds using walking device
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 407
Yuan-Yang Cheng, Dr., +886-4-2359-2525 ext. 3500, yycheng@vghtc.gov.tw
About this study
Investigators aimed to examine the effectiveness of robotic exoskeleton-assisted gait training in stroke rehabilitation, and to determine predicting factors of significant improvements in post-stroke patients. Investigators hypothesized that robotic assisted gait training brings better strength recovery and functional improvement.
- Conditions
- Stroke Sequelae
- Being tested
- Robotic exoskeleton-assisted gait rehabilitation, Conventional rehabilitation
- Keywords
- robotic rehabilitation, stroke, quality of life, walking speed
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic exoskeleton-assisted gait rehabilitationDevice
Use a robotic exoskeleton for gait rehabilitation in addition to conventional rehabilitation
Conventional rehabilitationOther
Regular post-stroke rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Robotic group | Experimental | This group receives conventional rehabilitation plus robotic exoskeleton-assisted gait rehabilitation. Receives: Device: Robotic exoskeleton-assisted gait rehabilitation |
| Control group | Active comparator | This group receives conventional rehabilitation alone. Receives: Other: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline distance walked in 6 minute walk test after entire rehabilitation program (4 weeks)
Measured: 4 weeks
Change from baseline time needed to complete Timed-Up-and-Go test after entire rehabilitation program (4 weeks)
Measured: 4 weeks
Change from baseline scores in 12-item short form survey after entire rehabilitation program (4 weeks)
12-item short form survey (SF-12): scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Measured: 4 weeks
Change from baseline Isokinetic strength after entire rehabilitation program (4 weeks)
tested by isokinetic dynamometer
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Jan 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825144
- Sponsor's protocol ID
- CF21277A
- Status last verified
- Mar 2023
- First submitted
- 19 Mar 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Robotic Exoskeleton-Assisted Gait Re-habilitation and Predictive Factors of Significant Improvements in Stroke Patients
- ClinicalTrials.gov ID
- NCT05825144
- Acronym / sponsor ID
- CF21277A
- Conditions
- Stroke Sequelae
- Keywords
- robotic rehabilitation, stroke, quality of life, walking speed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Apr 2023 (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.
Investigators aimed to examine the effectiveness of robotic exoskeleton-assisted gait training in stroke rehabilitation, and to determine predicting factors of significant improvements in post-stroke patients. Investigators hypothesized that robotic assisted gait training brings better strength recovery and functional improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic group | Experimental | Device: Robotic exoskeleton-assisted gait rehabilitationThis group receives conventional rehabilitation plus robotic exoskeleton-assisted gait rehabilitation. |
| Control group | Active comparator | Other: Conventional rehabilitationThis group receives conventional rehabilitation alone. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged from 30 to 80 years
- hemiparesis due to ischemic or hemorrhagic stroke in the last 6 months
Key exclusion criteria (5 listed)
- with a significant history of pain or injury of lower limbs that affected their walking ability,
- with cardiopulmonary diseases that prohibited exercise training
- with impaired cognitive function
- unable to complete the timed up-and-go test
- able to complete the timed up-and-go test in <20 seconds using walking device
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 |
|---|---|---|
| Robotic exoskeleton-assisted gait rehabilitationUse a robotic exoskeleton for gait rehabilitation in addition to conventional rehabilitation | Device | Robotic group |
| Conventional rehabilitationRegular post-stroke rehabilitation | Other | Control group |
Primary outcome
Change from baseline distance walked in 6 minute walk test after entire rehabilitation program (4 weeks)
Time frame: 4 weeks
Change from baseline time needed to complete Timed-Up-and-Go test after entire rehabilitation program (4 weeks)
Time frame: 4 weeks
Change from baseline scores in 12-item short form survey after entire rehabilitation program (4 weeks)
Time frame: 4 weeks
12-item short form survey (SF-12): scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Change from baseline Isokinetic strength after entire rehabilitation program (4 weeks)
Time frame: 4 weeks
tested by isokinetic dynamometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke Sequelae
Enrolling by invitationObservational study
Psychometric Study of the Spanish Version of Two Upper Limb Assessment Scales in Chronic Stroke
Chronic Stroke
Not yet recruitingPhase 2
ALT001 in Patients With Ischemic Stroke in the Sequelae Stage
Ischemic Stroke in the Sequelae Stage
Not yet recruiting
Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks
Stroke Sequelae, Deglutition Disorders
Active, not recruitingObservational study
A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development
Spasticity as Sequela of Stroke
Recruiting
TDCS to Improve Post-Stroke Cognitive Impairment
Stroke, Stroke Sequelae
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic exoskeleton-assisted gait rehabilitation and Conventional rehabilitation in people with Stroke Sequelae, run by Taichung Veterans General 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 2 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: status not confirmed, as of the sponsor's last update on 24 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan-Yang Cheng, Dr. (+886-4-2359-2525 ext. 3500, yycheng@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline distance walked in 6 minute walk test after entire rehabilitation program (4 weeks) (time frame: 4 weeks). The study lists 4 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 24 Apr 2023.