Development of an Intelligent Balance Training System Providing Weight-bearing Feedback in Stroke Patients

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Balance function, gait ability, weight- distribution and weight-shifting; Behavioral: Weight- distribution and weight-shifting training program

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Sanmin Dist
    • Kaohsiung City, Sanmin Dist, Taiwan, 80708
      • Li-Jiun Liaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy subjects; 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.	Behavioral: Balance function, gait ability, weight- distribution and weight-shifting; 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.
Experimental: Stroke subjects; 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.	Behavioral: Balance function, gait ability, weight- distribution and weight-shifting; 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.; Behavioral: Weight- distribution and weight-shifting training program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	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.	The assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Study Director: Li-Jiun Liaw, Kaohsiung Medical University Department of Physical Therapy Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2016
• Primary Completion (Actual): September 19, 2018
• Study Completion (Actual): September 19, 2018

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: KMUHIRB-F(II)-20150033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Currently in the submission stage ,and then share with other researchers after publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No