StrokeNCT05945134
Sit-to-stand Training With Interactive Feedback in Chronic Stroke
A study testing Visual and auditory feedback STS training and Conventional STS training in people with Stroke, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The major problems of people with chronic stroke include muscle weakness, sensory alteration, and inter-muscular coordination impairment. Inter-muscular coordination impairment caused altered muscle contraction sequences and weight-bearing asymmetry during functional activities. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Visual and auditory feedback STS training and Conventional STS training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jul 2023to 30 Jun 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stroke ≥ 6 months
- Mini-mental state examination (MMSE) ≥ 24 points
- Brunnstrom lower limb recovery stage: ≥ stage 3
- Be able to independently perform STS for at least 10 times
- Single STS >1.7 seconds
- Be able to walk ≥10 meters independently
Who cannot join
- Any other musculoskeletal, neurological and cardiovascular diseases
- Have visual or language impairments
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Yang Ming Chiao Tung University
Taipei, 112
Ray-Yau Wang, PhD, +886-2-28267210, rywang@nycu.edu.tw
About this study
Official title: Effects of Sit-to-stand Training With Interactive Feedback on Muscle Contraction Sequences and Weight Bearing Symmetry in Individuals With Chronic Stroke
The major problems of people with chronic stroke include muscle weakness, sensory alteration, and inter-muscular coordination impairment. Inter-muscular coordination impairment caused altered muscle contraction sequences and weight-bearing asymmetry during functional activities. Sit-to-stand (STS) training is often used to improve functional activities among post-stroke subjects. However, the improvement may come from compensatory movements. Using compensatory movement may cause muscle weakness in the affected side and increase fall risk. This study will develop a novel STS training system with interactive visual and audio feedback emphasizing weight transferring and weight bearing. The present study aims to investigate the effects of sit-to-stand training with interactive visual and audio feedback on muscle contraction sequences and weight bearing symmetry in individuals with chronic stroke.
Read the detailed description
This is a prospective randomized single-blinded controlled trial with pre- and post-measurements. 20 individuals will be recruited, and randomly assigned to experimental or control group. Statistical data analysis will be done by SPSS 24.0. Baseline characteristics will be analyzed using independent t-test or Chi-square test. Repeated measures two-way analysis of variance (ANOVA) with Tukey's post-hoc analysis will be used for time-by-group comparisons. The significant level is set at 0.05.
- Conditions
- Stroke
- Being tested
- Visual and auditory feedback STS training, Conventional STS training
- Keywords
- Interactive feedback, Muscle contraction sequence, Weight bearing symmetry, Sit-to-stand training, Chronic stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual and auditory feedback STS trainingOther
30 minutes per session, 3 sessions per week, for a total of 3 weeks. The visual and auditory feedback signals will be given throughout the sit-to-stand movement. As the size of circle representing the weight bearing gets more even, and the mobile dot indicating the overall center of pressure moves forward and approaches the midline, the auditory cues will get louder to indicate proximity to the target. It allows the participants to adjust and relearn the correct weight shifting and symmetry.
The intensity will be adjusted based on different chair heights (e.g. 115%, 100%, 80% of lower leg length), various seat materials, and supported level of thigh (progressing from one-third of the length between the greater trochanter of the femur and the knee joint line to full support). The training program will be progressed according to the abilities of the participants.
Conventional STS trainingOther
30 minutes per session, 3 sessions per week, for a total of 3 weeks. All settings will be the same as the experimental group, except for the feedback. In the control group, the verbal cues will be given by the physical therapist and a mirror will be placed in front of the participant for visual feedback. During the sit-to-stand movement, participants will be asked to try to maintain the alignment in the midline.
| Study group | Role | What they receive |
|---|---|---|
| Visual and auditory feedback STS training group | Experimental | The interactive interface of visual and auditory feedback system was designed using LabVIEW and integrated force plates for training. Signals from the pressure detectors of the seat and two force plates on the floor will be converted to the indication of the body weight distribution (indicated by the size of the two circles of both legs, larger circle represented the more weight beard on the leg) and the movement path of the overall center of pressure (indicated by a mobile solid dot). Receives: Other: Visual and auditory feedback STS training |
| Conventional STS training group | Active comparator | Only verbal and visual cues which were commonly used by the therapist. Receives: Other: Conventional STS training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sit to stand performance: change in onset time of muscle contraction sequences
Use the surface electromyography to evaluate the "onset" time (% MT, EMG activities ≥ 2 SD of the baseline for ≥100 ms) of different muscles recruited during sit to stand (rectus femoris, biceps femoris, gluteus maximus, tibialis anterior, gastrocnemius, and soleus)
Measured: 5 minutes, Change from baseline onset time at 3-week post-test
Sit to stand performance: change in peak force time of muscle contraction sequences
Use the surface electromyography to evaluate the "peak force" time (% MT, maximal EMG activities) of different muscles recruited during sit to stand (rectus femoris, biceps femoris, gluteus maximus, tibialis anterior, gastrocnemius, and soleus)
Measured: 5 minutes, Change from baseline peak force time at 3-week post-test
Sit to stand performance: change in offset time of muscle contraction sequences
Use the surface electromyography to evaluate the "offset" time (% MT, EMG activities < 2 SD of the baseline for ≥100 ms) of different muscles recruited during sit to stand (rectus femoris, biceps femoris, gluteus maximus, tibialis anterior, gastrocnemius, and soleus)
Measured: 5 minutes, Change from baseline offset time at 3-week post-test
Sit to stand performance: change in weight bearing symmetry
Use the force plates to evaluate the "cumulative vertical force " (% of body weight), and calculate with the "asymmetry ratio" = |1-affected side/less affected side|
Measured: 5 minutes, Change from baseline weight bearing symmetry at 3-week post-test
Sit to stand performance: change in COP sway pathway
Use the force plates to evaluate the total length (cm) of the moving pathway of the overall center of pressure in X or Y axis individually
Measured: 5 minutes, Change from baseline COP sway pathway at 3-week post-test
Secondary outcomes (4)
Sit to stand performance: change in sit to stand duration
Use the surface electromyography to evaluate the "movement time" (MT, sec), using the "offset time of the last activated muscle" - "onset time of the first activated muscle"
Measured: 5 minutes, Change from baseline sit to stand duration at 3-week post-test
Gait performance: change in symmetry of gait speed
Use the GAITRite® system to evaluate gait speed (m/s) in comfortable speed (with/ without assisted device), and calculate with the "asymmetry ratio" = |1-affected side/less affected side|
Measured: 5 minutes, Change from baseline symmetry of gait speed at 3-week post-test
Gait performance: change in symmetry of step length
Use the GAITRite® system to evaluate step length (m) in comfortable speed (with/ without assisted device), and calculate with the "asymmetry ratio" = |1-affected side/less affected side|
Measured: 5 minutes, Change from baseline symmetry of step length at 3-week post-test
Gait performance: change in symmetry of step time
Use the GAITRite® system to evaluate step time (sec) in comfortable speed (with/ without assisted device), and calculate with the "asymmetry ratio" = |1-affected side/less affected side|
Measured: 5 minutes, Change from baseline symmetry of step time at 3-week post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start15 Jul 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (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 National Yang Ming Chiao Tung 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ray-Yau Wang, PhD, Principal investigator, rywang@nycu.edu.tw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945134
- Sponsor's protocol ID
- NYCU112081AE
- Status last verified
- Jun 2023
- First submitted
- 3 Jul 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sit-to-stand Training With Interactive Feedback on Muscle Contraction Sequences and Weight Bearing Symmetry in Individuals With Chronic Stroke
- ClinicalTrials.gov ID
- NCT05945134
- Acronym / sponsor ID
- NYCU112081AE
- Conditions
- Stroke
- Keywords
- Interactive feedback, Muscle contraction sequence, Weight bearing symmetry, Sit-to-stand training, Chronic stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 14 Jul 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.
The major problems of people with chronic stroke include muscle weakness, sensory alteration, and inter-muscular coordination impairment. Inter-muscular coordination impairment caused altered muscle contraction sequences and weight-bearing asymmetry during functional activities. Sit-to-stand (STS) training is often used to improve functional activities among post-stroke subjects. However, the improvement may come from compensatory movements. Using compensatory movement may cause muscle weakness in the affected side and increase fall risk. This study will develop a novel STS training system with interactive visual and audio feedback emphasizing weight transferring and weight bearing. The present study aims to investigate the effects of sit-to-stand training with interactive visual and audio feedback on muscle contraction sequences and weight bearing symmetry in individuals with chronic stroke.
Detailed description
This is a prospective randomized single-blinded controlled trial with pre- and post-measurements. 20 individuals will be recruited, and randomly assigned to experimental or control group. Statistical data analysis will be done by SPSS 24.0. Baseline characteristics will be analyzed using independent t-test or Chi-square test. Repeated measures two-way analysis of variance (ANOVA) with Tukey's post-hoc analysis will be used for time-by-group comparisons. The significant level is set at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual and auditory feedback STS training group | Experimental | Other: Visual and auditory feedback STS trainingThe interactive interface of visual and auditory feedback system was designed using LabVIEW and integrated force plates for training. Signals from the pressure detectors of the seat and two force plates on the floor will be converted to the indication of the body weight distribution (indicated by the size of the two circles of both legs, larger circle represented the more weight beard on the leg) and the movement path of the overall center of pressure (indicated by a mobile solid dot). |
| Conventional STS training group | Active comparator | Other: Conventional STS trainingOnly verbal and visual cues which were commonly used by the therapist. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of stroke ≥ 6 months
- Mini-mental state examination (MMSE) ≥ 24 points
- Brunnstrom lower limb recovery stage: ≥ stage 3
- Be able to independently perform STS for at least 10 times
- Single STS >1.7 seconds
Key exclusion criteria (2 listed)
- Any other musculoskeletal, neurological and cardiovascular diseases
- Have visual or language impairments
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 |
|---|---|---|
| Visual and auditory feedback STS training30 minutes per session, 3 sessions per week, for a total of 3 weeks. The visual and auditory feedback signals will be given throughout the sit-to-stand movement. As the size of circle representing the weight bearing gets more even, and the mobile dot indicating the overall center of pressure moves forward and approaches the midline, the auditory cues will get louder to indicate proximity to the target. It allows the participants to adjust and relearn the correct weight shifting and symmetry. The intensity will be adjusted based on different chair heights (e.g. 115%, 100%, 80% of lower leg length), various seat materials, and supported level of thigh (progressing from one-third of the length between the greater trochanter of the femur and the knee joint line to full support). The training program will be progressed according to the abilities of the participants. | Other | Visual and auditory feedback STS training group |
| Conventional STS training30 minutes per session, 3 sessions per week, for a total of 3 weeks. All settings will be the same as the experimental group, except for the feedback. In the control group, the verbal cues will be given by the physical therapist and a mirror will be placed in front of the participant for visual feedback. During the sit-to-stand movement, participants will be asked to try to maintain the alignment in the midline. | Other | Conventional STS training group |
Primary outcome
Sit to stand performance: change in onset time of muscle contraction sequences
Time frame: 5 minutes, Change from baseline onset time at 3-week post-test
Use the surface electromyography to evaluate the "onset" time (% MT, EMG activities ≥ 2 SD of the baseline for ≥100 ms) of different muscles recruited during sit to stand (rectus femoris, biceps femoris, gluteus maximus, tibialis anterior, gastrocnemius, and soleus)
Sit to stand performance: change in peak force time of muscle contraction sequences
Time frame: 5 minutes, Change from baseline peak force time at 3-week post-test
Use the surface electromyography to evaluate the "peak force" time (% MT, maximal EMG activities) of different muscles recruited during sit to stand (rectus femoris, biceps femoris, gluteus maximus, tibialis anterior, gastrocnemius, and soleus)
Sit to stand performance: change in offset time of muscle contraction sequences
Time frame: 5 minutes, Change from baseline offset time at 3-week post-test
Use the surface electromyography to evaluate the "offset" time (% MT, EMG activities < 2 SD of the baseline for ≥100 ms) of different muscles recruited during sit to stand (rectus femoris, biceps femoris, gluteus maximus, tibialis anterior, gastrocnemius, and soleus)
Sit to stand performance: change in weight bearing symmetry
Time frame: 5 minutes, Change from baseline weight bearing symmetry at 3-week post-test
Use the force plates to evaluate the "cumulative vertical force " (% of body weight), and calculate with the "asymmetry ratio" = |1-affected side/less affected side|
Sit to stand performance: change in COP sway pathway
Time frame: 5 minutes, Change from baseline COP sway pathway at 3-week post-test
Use the force plates to evaluate the total length (cm) of the moving pathway of the overall center of pressure in X or Y axis individually
4 secondary outcomes
Sit to stand performance: change in sit to stand duration
Time frame: 5 minutes, Change from baseline sit to stand duration at 3-week post-test
Gait performance: change in symmetry of gait speed
Time frame: 5 minutes, Change from baseline symmetry of gait speed at 3-week post-test
Gait performance: change in symmetry of step length
Time frame: 5 minutes, Change from baseline symmetry of step length at 3-week post-test
Gait performance: change in symmetry of step time
Time frame: 5 minutes, Change from baseline symmetry of step time at 3-week post-test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
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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.
Ray-Yau Wang, PhD principal investigator
rywang@nycu.edu.tw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual and auditory feedback STS training and Conventional STS training 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 6 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 18 Jul 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 Ray-Yau Wang, PhD (+886-2-28267210, rywang@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sit to stand performance: change in onset time of muscle contraction sequences (time frame: 5 minutes, Change from baseline onset time at 3-week post-test). The study lists 5 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 18 Jul 2023; AzTrials last refreshed its copy on 2 Nov 2026.