Development of an Intelligent Balance Training System Providing Weight-bearing Feedback in Stroke Patients
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Balance function, gait ability, weight- distribution and weight-shifting
Weight- distribution and weight-shifting training program
Sponsored by

About this trial
This is an interventional other trial for Stroke
Eligibility Criteria
Inclusion Criteria:
Healthy adults
a. 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
Exclusion Criteria:
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
Sites / Locations
- Li-Jiun Liaw
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Healthy subjects
Stroke subjects
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
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
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04841161
First Posted
March 8, 2021
Last Updated
April 8, 2021
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04841161
Brief Title
Development of an Intelligent Balance Training System Providing Weight-bearing Feedback in Stroke Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 25, 2016 (Actual)
Primary Completion Date
September 19, 2018 (Actual)
Study Completion Date
September 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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
1. 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.
2. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy subjects
Arm Type
Other
Arm Description
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.
Arm Title
Stroke subjects
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Balance function, gait ability, weight- distribution and weight-shifting
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Weight- distribution and weight-shifting training program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in performance of weight distribution after 8 sessions intervention
Description
By using the force plate to record the ground reaction force and then to obtain weight distribution while performing the sit to stand activity
Time Frame
The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
Title
Changes in performance of standing balance after 8 sessions intervention
Description
By using the force plate to obtain displacements of the center of pressure (COP) while standing and weight transfer
Time Frame
The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
Title
Changes in performance of static and dynamic balance after 8 sessions intervention
Description
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.
Time Frame
The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
Title
Changes in performance of balance function after 8 sessions intervention
Description
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.
Time Frame
The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
Title
Changes in performance of dynamic balance after 8 sessions intervention
Description
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.
Time Frame
The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults
a. 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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Jiun Liaw
Organizational Affiliation
Kaohsiung Medical University Department of Physical Therapy Associate Professor
Official's Role
Study Director
Facility Information:
Facility Name
Li-Jiun Liaw
City
Kaohsiung City
State/Province
Sanmin Dist
ZIP/Postal Code
80708
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Currently in the submission stage ,and then share with other researchers after publication
Learn more about this trial
Development of an Intelligent Balance Training System Providing Weight-bearing Feedback in Stroke Patients
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