StrokeNCT04438343
Impairment-Specific and Augmented Intervention on Turning
A study testing Impairment-specific and augmented intervention and Conventional physical therapy in people with Stroke, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The objective of this study is to investigate the effects of the impairment-specific and augmented intervention based balance and strength training on turning performance in individuals with chronic stroke. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Impairment-specific and augmented intervention and Conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Sep 2020to 31 Dec 2021
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≧ 6 months post first-ever stroke with unilateral motor deficits
- ≧20 years of age
- The ability to walk independently for at least 7 m with or without using walking aids
- Score ≧ 24 of 30 on the Mini-Mental State Examination
Who cannot join
- Unstable medical conditions (e.g., deep vein thrombosis, aspiration pneumonia, or superimposed sepsis)
- History of other diseases known to interfere with participation in the study (e.g., heart failure, hemineglect, or diabetic neuropathy)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Yea-Ru Yang
Taipei, Beitou, 112
Yea-Ru Yang, +886228267279, yryang@nycu.edu.tw
Yea-Ru Yang, PhD
About this study
Official title: Effects of Impairment-Specific and Augmented Intervention on Turning Performance in Individuals With Chronic Stroke
The objective of this study is to investigate the effects of the impairment-specific and augmented intervention based balance and strength training on turning performance in individuals with chronic stroke.
- Conditions
- Stroke
- Being tested
- Impairment-specific and augmented intervention, Conventional physical therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impairment-specific and augmented interventionOther
Balance and lower extremities strength training
Conventional physical therapyOther
Trunk and upper extremity training
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Other: Impairment-specific and augmented intervention |
| control group | Active comparator | Not described Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turning performance
Using a turning characteristic evaluation system to evaluate the swing time, stance time, turning speed, and stride length of the participants during turning
Measured: Change from baseline at 4 week
Secondary outcomes (6)
Balance
Berg Balance Scale Limits of stability (LOS) using NeuroCom Smart Balance Master (NeuroCom International, Clackamas, OR)
Measured: Change from baseline at 4 week
Strength
Using handheld dynamometer
Measured: Change from baseline at 4 week
Straight walking performance
Using GAITRite system (CIR system, Inc, Havertown, PS) calculate walking speed, cadence, swing time, stance time, and step length
Measured: Change from baseline at 4 week
Timed up and go test
Measured: Change from baseline at 4 week
Falls Efficacy Scale International (Chinese)
Measured: Change from baseline at 4 week
Stroke Impact Scale (SIS) Taiwan version
Measured: Change from baseline at 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start11 Sep 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438343
- Sponsor's protocol ID
- YM109070F
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2020
- Last updated
- 22 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Impairment-Specific and Augmented Intervention on Turning Performance in Individuals With Chronic Stroke
- ClinicalTrials.gov ID
- NCT04438343
- Acronym / sponsor ID
- YM109070F
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Jun 2020 (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.
The objective of this study is to investigate the effects of the impairment-specific and augmented intervention based balance and strength training on turning performance in individuals with chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Impairment-specific and augmented intervention |
| control group | Active comparator | Other: Conventional physical therapy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≧ 6 months post first-ever stroke with unilateral motor deficits
- ≧20 years of age
- The ability to walk independently for at least 7 m with or without using walking aids
- Score ≧ 24 of 30 on the Mini-Mental State Examination
Key exclusion criteria (2 listed)
- Unstable medical conditions (e.g., deep vein thrombosis, aspiration pneumonia, or superimposed sepsis)
- History of other diseases known to interfere with participation in the study (e.g., heart failure, hemineglect, or diabetic neuropathy)
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 |
|---|---|---|
| Impairment-specific and augmented interventionBalance and lower extremities strength training | Other | experimental group |
| Conventional physical therapyTrunk and upper extremity training | Other | control group |
Primary outcome
Turning performance
Time frame: Change from baseline at 4 week
Using a turning characteristic evaluation system to evaluate the swing time, stance time, turning speed, and stride length of the participants during turning
6 secondary outcomes
Balance
Time frame: Change from baseline at 4 week
Strength
Time frame: Change from baseline at 4 week
Straight walking performance
Time frame: Change from baseline at 4 week
Timed up and go test
Time frame: Change from baseline at 4 week
Falls Efficacy Scale International (Chinese)
Time frame: Change from baseline at 4 week
Stroke Impact Scale (SIS) Taiwan version
Time frame: Change from baseline at 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
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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. 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 Impairment-specific and augmented intervention and Conventional physical therapy in people with Stroke, run by National Yang Ming Chiao Tung University 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 2 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 22 Jun 2021. 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 Yea-Ru Yang (+886228267279, yryang@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turning performance (time frame: Change from baseline at 4 week). 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 22 Jun 2021.