StrokeNCT04637737
Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Subacute Stroke
A study testing anterioposterior Weight Shifting Training with Visual Biofeedback and Conventional therapy in people with Stroke, run by Yonsei University at 1 site in South Korea.
Trial summary
Asymmetric gait patterns of stroke is one of the most important functional activities to enable community participation, it is major goal for stroke patients. Reported that the stroke patients had asymmetry at stance time, single stance, double support time, and swing time compared to normal people, and claimed that… Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- anterioposterior Weight Shifting Training with Visual Biofeedback and Conventional therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2014to Jun 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- less than 6 months after onset of the stroke
- can stand and walk independently 10m
- K-MMSE score of at least 15
- have asymmetrical gait pattern with Step length asymmetric ratio greater than 1.1
- over 20 years of age.
Who cannot join
- quadriplegia
- past history of stroke
- past history of Musculoskeletal disease or history of Neurological diseases
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
Seoul
Deog Young Kim, +82-2-2228-3714, KIMDY@yuhs.ac
About this study
Asymmetric gait patterns of stroke is one of the most important functional activities to enable community participation, it is major goal for stroke patients. Reported that the stroke patients had asymmetry at stance time, single stance, double support time, and swing time compared to normal people, and claimed that the most important factor was step length. According to Albert et al., patients with an asymmetric gait pattern have a long double support phase and a healthy side single support phase, and less weight shift to the affected side. Recent studies have shown that visual feedback for weight shift may be helpful to obtain a symmetrical posture after stroke. However, no study has been conducted on the therapeutic effect on gait asymmetry and patterns. We aimed to investigate the effect of Anterioposterior Weight Shifting Training with Visual Biofeedback in subacute post-stroke patients on gait asymmetry and pattern.
40 subacute post-stroke patients with Step Length Asymmetry were enrolled in this study. The subjects were randomly assigned into two groups. The training group received an additional anterioposterior weight shifting training with visual Biofeedback 5 times per week for 4weeks. The control group received the usual gait training. The spatiotemporal and kinematic data were obtained during walking through 3D motion analysis. Functional Ambulation Category, Self-selected walking speed, Maximum safe walking speed, Berg balance Test (BBT), Fugl-Meyer Assessment (FMA), Medical Research Council Score (MRC), Functional Independent Measure-mobility, Timed Up and Go test (TUG) were assessed at pre, during, post- training, and 4week follow-up. Those were compared between two groups by repeated measures ANOVA.
- Conditions
- Stroke
- Being tested
- anterioposterior Weight Shifting Training with Visual Biofeedback, Conventional therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterioposterior Weight Shifting Training with Visual BiofeedbackDevice
The training group received an additional anterioposterior weight shifting training with visual Biofeedback 5 times per week for 4weeks. AP training is made to instantly know your training status during training by measuring and processing the foot pressure in real time using the F-Scan (Tekscan) hardware system and Software Development Kit (SDK).
Before training, all patients are instructed to place both feet at shoulder width, place the inverted foot approximately 30 cm in front of the unaffected side foot, move the body forward with the chest straight in an upright position, and be instructed to put the weight on the affected side.
On the screen shown, measure the maximum weight distribution during the first 10 times and set the value added by 5% as the target value.
It is designed to induce the maximum weight shift through the archery game.
Conventional therapyBehavioural
The control group received the usual gait training.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Not described Receives: Device: anterioposterior Weight Shifting Training with Visual Biofeedback |
| Control group | Other | Not described Receives: Behavioral: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step Length Asymmetric Ratio
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Measured: before training(0week)
Step Length Asymmetric Ratio
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Measured: during training(2week)
Step Length Asymmetric Ratio
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Measured: after training(4week)
Step Length Asymmetric Ratio
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Measured: Follow up(8week)
Step Length Asymmetric Index
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Measured: before training(0week)
Step Length Asymmetric Index
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Measured: during training(2week)
Step Length Asymmetric Index
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Measured: after training(4week)
Step Length Asymmetric Index
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Measured: Follow up(8week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Oct 2014
- Primary completionJun 2021 (estimated)
- Study completionJun 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.
- More trials run by Yonsei UniversityThe 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deog Young Kim, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637737
- Sponsor's protocol ID
- 4-2014-0383
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Subacute Stroke
- ClinicalTrials.gov ID
- NCT04637737
- Acronym / sponsor ID
- 4-2014-0383
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Oct 2014
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 20 Nov 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.
Asymmetric gait patterns of stroke is one of the most important functional activities to enable community participation, it is major goal for stroke patients. Reported that the stroke patients had asymmetry at stance time, single stance, double support time, and swing time compared to normal people, and claimed that the most important factor was step length. According to Albert et al., patients with an asymmetric gait pattern have a long double support phase and a healthy side single support phase, and less weight shift to the affected side. Recent studies have shown that visual feedback for weight shift may be helpful to obtain a symmetrical posture after stroke. However, no study has been conducted on the therapeutic effect on gait asymmetry and patterns. We aimed to investigate the effect of Anterioposterior Weight Shifting Training with Visual Biofeedback in subacute post-stroke patients on gait asymmetry and pattern.
40 subacute post-stroke patients with Step Length Asymmetry were enrolled in this study. The subjects were randomly assigned into two groups. The training group received an additional anterioposterior weight shifting training with visual Biofeedback 5 times per week for 4weeks. The control group received the usual gait training. The spatiotemporal and kinematic data were obtained during walking through 3D motion analysis. Functional Ambulation Category, Self-selected walking speed, Maximum safe walking speed, Berg balance Test (BBT), Fugl-Meyer Assessment (FMA), Medical Research Council Score (MRC), Functional Independent Measure-mobility, Timed Up and Go test (TUG) were assessed at pre, during, post- training, and 4week follow-up. Those were compared between two groups by repeated measures ANOVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Device: anterioposterior Weight Shifting Training with Visual Biofeedback |
| Control group | Other | Behavioral: Conventional therapy |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- less than 6 months after onset of the stroke
- can stand and walk independently 10m
- K-MMSE score of at least 15
- have asymmetrical gait pattern with Step length asymmetric ratio greater than 1.1
- over 20 years of age.
Key exclusion criteria (3 listed)
- quadriplegia
- past history of stroke
- past history of Musculoskeletal disease or history of Neurological diseases
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 |
|---|---|---|
| anterioposterior Weight Shifting Training with Visual BiofeedbackThe training group received an additional anterioposterior weight shifting training with visual Biofeedback 5 times per week for 4weeks. AP training is made to instantly know your training status during training by measuring and processing the foot pressure in real time using the F-Scan (Tekscan) hardware system and Software Development Kit (SDK). Before training, all patients are instructed to place both feet at shoulder width, place the inverted foot approximately 30 cm in front of the unaffected side foot, move the body forward with the chest straight in an upright position, and be instructed to put the weight on the affected side. On the screen shown, measure the maximum weight distribution during the first 10 times and set the value added by 5% as the target value. It is designed to induce the maximum weight shift through the archery game. | Device | Training group |
| Conventional therapyThe control group received the usual gait training. | Behavioural | Control group |
Primary outcome
Step Length Asymmetric Ratio
Time frame: before training(0week)
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Step Length Asymmetric Ratio
Time frame: during training(2week)
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Step Length Asymmetric Ratio
Time frame: after training(4week)
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Step Length Asymmetric Ratio
Time frame: Follow up(8week)
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Step Length Asymmetric Index
Time frame: before training(0week)
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Step Length Asymmetric Index
Time frame: during training(2week)
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Step Length Asymmetric Index
Time frame: after training(4week)
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Step Length Asymmetric Index
Time frame: Follow up(8week)
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Deog Young Kim principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anterioposterior Weight Shifting Training with Visual Biofeedback and Conventional therapy in people with Stroke, run by Yonsei University at 1 site in South Korea.
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 5 inclusion and 3 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 20 Nov 2020. 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 South Korea. 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 Deog Young Kim (+82-2-2228-3714, KIMDY@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step Length Asymmetric Ratio (time frame: before training(0week)). The study lists 8 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 20 Nov 2020.