StrokeNCT04841161
Development of an Intelligent Balance Training System Providing Weight-bearing Feedback in Stroke Patients
A study testing Balance function, gait ability, weight- distribution and weight-shifting and Weight- distribution and weight-shifting training program in people with Stroke, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The sit-to-stand and dynamic weight-shifting ability of stroke patients is highly associated with walking performance. Therefore, in order to improve the dynamic weight-shifting ability in sit-to-stand and parallel or tandem standing, a real-time visual or auditory feedback is used in our design to allow patients to… Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Balance function, gait ability, weight- distribution and weight-shifting and Weight- distribution and weight-shifting training program
- 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
- 25 Feb 2016to 19 Sep 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- Their age should be ranged between 20 - 75 years
- Stroke patients
- diagnosed with unilateral ischemic or hemorrhagic stroke
- a minimum of six months post stroke
- able to stand without support for 1 minutes
- medically stable with physician release
Who cannot join
- Healthy adults
- neurological diseases
- musculoskeletal diseases
- rheumatic diseases
- history of orthopedic surgery on spine or lower extremity
- Stroke patients
- other injuries or illnesses that affect standing or walking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Intelligent Balance Training System Providing Weight-bearing Feedback Via Force Platform to Improve Sit-to-stand, Dynamic Weight-shifting and Standing Performance in Stroke Patients
The sit-to-stand and dynamic weight-shifting ability of stroke patients is highly associated with walking performance. Therefore, in order to improve the dynamic weight-shifting ability in sit-to-stand and parallel or tandem standing, a real-time visual or auditory feedback is used in our design to allow patients to realize the weight-bearing condition (by using load cells) in both sound and affected legs immediately. It can help patients to learn to control muscle to shift weight effectively which will improve patients' walking performance. By integrating physical therapy planning with electro-mechanical technology, the goal of this study is to develop a standing balance training system by requiring patients to control their center of pressure (COP) in performing sit-to-stand and maintain a standing posture via the use of their core and lower extremity musculature.
Read the detailed description
- Written informed consent must be obtained before any study specific procedures are undertaken.
- For healthy group: Participants will be recruited from the staffs and students in Kaohsiung Medical University (including Learning University), and healthy families of CVA patients in the university affiliated hospital.
- For stroke (CVA) group: We will ask the physical therapists in the university affiliated hospital to nominate the potential CVA participants . The physicians will determine if they would meet the inclusion criteria before participating the present study.
- The process of the experiment (brief describe)
- Written informed consent must be obtained before any study specific procedures are undertaken.
- Subjects who are recruited to participate in this experiment should provide the personal information forms first (ex: sex, age, height, weight, post-stroke duration, stroke type, hemiplegic side, ambulation devices etc.). Then, assessment (PASS, Berg Balance Scale, Timed Up and Go) will be conducted by a physical therapist at baseline.
- While the stroke patients after completing the 4 -times, and 8-times training program, the above-mentioned assessment conducted again by the same physical therapist. The healthy will not receive balance training, thus .only receive one assessment.
- Conditions
- Stroke
- Being tested
- Balance function, gait ability, weight- distribution and weight-shifting, Weight- distribution and weight-shifting training program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance function, gait ability, weight- distribution and weight-shiftingBehavioural
Healthy adults and stroke patients accepted two measurements within a week. Balance function, gait ability, weight- distribution and weight-shifting during sit-to-stand, quite standing, and weight-shifting toward the forward foot.
Weight- distribution and weight-shifting training programBehavioural
The stroke patients received a weight-shifting training program , 30 minutes/time, 2-5 days a week for 2-3 weeks(8 sessions). After training, they accepted a post-test within a week.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Other | The healthy adults who have not any neurological, musculoskeletal or rhematogical disease, a history of orthopedic surgery on spine or lower extremity. Their age should be ranged between 20 - 75 years. Receives: Behavioral: Balance function, gait ability, weight- distribution and weight-shifting |
| Stroke subjects | Experimental | Stroke patients were included if they were: (1) diagnosed with unilateral ischemic or hemorrhagic stroke; (2) a minimum of six months post stroke ; (2) able to stand without support for 1 minutes; (3) able to understand and follow verbal instructions. and (4) medically stable with physician release. Receives: Behavioral: Balance function, gait ability, weight- distribution and weight-shifting; Behavioral: Weight- distribution and weight-shifting training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in performance of weight distribution after 8 sessions intervention
By using the force plate to record the ground reaction force and then to obtain weight distribution while performing the sit to stand activity
Measured: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
Changes in performance of standing balance after 8 sessions intervention
By using the force plate to obtain displacements of the center of pressure (COP) while standing and weight transfer
Measured: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
Changes in performance of static and dynamic balance after 8 sessions intervention
By using the Postural Assessment Scale of Stroke (PASS) to assess and monitor postural control. The PASS consists of 2 sections with a 4-point scale to describe each task. The total score ranges from 0 - 36.
Measured: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
Changes in performance of balance function after 8 sessions intervention
By using the Berg Balance Scale to assess balance function. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4during a series of predetermined tasks. The total score ranges from 0 - 56.
Measured: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
Changes in performance of dynamic balance after 8 sessions intervention
By using Timed Up and Go Test (TUG) to assess fall risk and measure the progress of balance. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.
Measured: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start25 Feb 2016
- Primary completion19 Sep 2018
- Study completion19 Sep 2018
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 Kaohsiung Medical University Chung-Ho 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Jiun Liaw, Study director, Kaohsiung Medical University Department of Physical Therapy Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841161
- Sponsor's protocol ID
- KMUHIRB-F(II)-20150033
- Status last verified
- Feb 2021
- First submitted
- 8 Mar 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently in the submission stage ,and then share with other researchers after publication
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Intelligent Balance Training System Providing Weight-bearing Feedback Via Force Platform to Improve Sit-to-stand, Dynamic Weight-shifting and Standing Performance in Stroke Patients
- ClinicalTrials.gov ID
- NCT04841161
- Acronym / sponsor ID
- KMUHIRB-F(II)-20150033
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 25 Feb 2016 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 19 Sep 2018 (actual)
- First posted
- 12 Apr 2021 (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 sit-to-stand and dynamic weight-shifting ability of stroke patients is highly associated with walking performance. Therefore, in order to improve the dynamic weight-shifting ability in sit-to-stand and parallel or tandem standing, a real-time visual or auditory feedback is used in our design to allow patients to realize the weight-bearing condition (by using load cells) in both sound and affected legs immediately. It can help patients to learn to control muscle to shift weight effectively which will improve patients' walking performance. By integrating physical therapy planning with electro-mechanical technology, the goal of this study is to develop a standing balance training system by requiring patients to control their center of pressure (COP) in performing sit-to-stand and maintain a standing posture via the use of their core and lower extremity musculature.
Detailed description
- Written informed consent must be obtained before any study specific procedures are undertaken.
- For healthy group: Participants will be recruited from the staffs and students in Kaohsiung Medical University (including Learning University), and healthy families of CVA patients in the university affiliated hospital.
- For stroke (CVA) group: We will ask the physical therapists in the university affiliated hospital to nominate the potential CVA participants . The physicians will determine if they would meet the inclusion criteria before participating the present study.
- The process of the experiment (brief describe)
- Written informed consent must be obtained before any study specific procedures are undertaken.
- Subjects who are recruited to participate in this experiment should provide the personal information forms first (ex: sex, age, height, weight, post-stroke duration, stroke type, hemiplegic side, ambulation devices etc.). Then, assessment (PASS, Berg Balance Scale, Timed Up and Go) will be conducted by a physical therapist at baseline.
- While the stroke patients after completing the 4 -times, and 8-times training program, the above-mentioned assessment conducted again by the same physical therapist. The healthy will not receive balance training, thus .only receive one assessment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Other | Behavioral: Balance function, gait ability, weight- distribution and weight-shiftingThe healthy adults who have not any neurological, musculoskeletal or rhematogical disease, a history of orthopedic surgery on spine or lower extremity. Their age should be ranged between 20 - 75 years. |
| Stroke subjects | Experimental | Behavioral: Balance function, gait ability, weight- distribution and weight-shifting, Behavioral: Weight- distribution and weight-shifting training programStroke patients were included if they were: (1) diagnosed with unilateral ischemic or hemorrhagic stroke; (2) a minimum of six months post stroke ; (2) able to stand without support for 1 minutes; (3) able to understand and follow verbal instructions. and (4) medically stable with physician release. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy adults
- Stroke patients
Key exclusion criteria (7 listed)
- Healthy adults
- Stroke patients
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 |
|---|---|---|
| Balance function, gait ability, weight- distribution and weight-shiftingHealthy adults and stroke patients accepted two measurements within a week. Balance function, gait ability, weight- distribution and weight-shifting during sit-to-stand, quite standing, and weight-shifting toward the forward foot. | Behavioural | Healthy subjects, Stroke subjects |
| Weight- distribution and weight-shifting training programThe stroke patients received a weight-shifting training program , 30 minutes/time, 2-5 days a week for 2-3 weeks(8 sessions). After training, they accepted a post-test within a week. | Behavioural | Stroke subjects |
Primary outcome
Changes in performance of weight distribution after 8 sessions intervention
Time frame: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
By using the force plate to record the ground reaction force and then to obtain weight distribution while performing the sit to stand activity
Changes in performance of standing balance after 8 sessions intervention
Time frame: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
By using the force plate to obtain displacements of the center of pressure (COP) while standing and weight transfer
Changes in performance of static and dynamic balance after 8 sessions intervention
Time frame: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
By using the Postural Assessment Scale of Stroke (PASS) to assess and monitor postural control. The PASS consists of 2 sections with a 4-point scale to describe each task. The total score ranges from 0 - 36.
Changes in performance of balance function after 8 sessions intervention
Time frame: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
By using the Berg Balance Scale to assess balance function. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4during a series of predetermined tasks. The total score ranges from 0 - 56.
Changes in performance of dynamic balance after 8 sessions intervention
Time frame: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
By using Timed Up and Go Test (TUG) to assess fall risk and measure the progress of balance. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Individual participant dataSharing planned: No. Currently in the submission stage ,and then share with other researchers after publication
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Li-Jiun Liaw study director
Kaohsiung Medical University Department of Physical Therapy Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance function, gait ability, weight- distribution and weight-shifting and Weight- distribution and weight-shifting training program in people with Stroke, run by Kaohsiung Medical University Chung-Ho 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 12 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in performance of weight distribution after 8 sessions intervention (time frame: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)). 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 12 Apr 2021.