Clinical trial NCT04841161: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.

1. 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.
2. 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)

1. Written informed consent must be obtained before any study specific procedures are undertaken.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

1. Healthy adults

   a. Their age should be ranged between 20 - 75 years
2. Stroke patients

   1. diagnosed with unilateral ischemic or hemorrhagic stroke
   2. a minimum of six months post stroke
   3. able to stand without support for 1 minutes
   4. medically stable with physician release

Exclusion Criteria:

1. Healthy adults

   1. neurological diseases
   2. musculoskeletal diseases
   3. rheumatic diseases
   4. history of orthopedic surgery on spine or lower extremity
2. Stroke patients

   1. other injuries or illnesses that affect standing or walking

Primary outcomes:
measure: Changes in performance of weight distribution after 8 sessions intervention
timeFrame: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
measure: Changes in performance of standing balance after 8 sessions intervention
timeFrame: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
measure: Changes in performance of static and dynamic balance after 8 sessions intervention
timeFrame: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
measure: Changes in performance of balance function after 8 sessions intervention
timeFrame: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
measure: Changes in performance of dynamic balance after 8 sessions intervention
timeFrame: The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Li-Jiun Liaw
state: Sanmin Dist
Study officials:
affiliation: Kaohsiung Medical University Department of Physical Therapy Associate Professor
name: Li-Jiun Liaw
role: STUDY_DIRECTOR
References: