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

NCT04841161 | Completed

• 1 other identifier: KMUHIRB-F(II)-20150033
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (2)

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.

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.

Behavioral: Balance function, gait ability, weight- distribution and weight-shifting; Behavioral: Weight- distribution and weight-shifting training program

Interventions

Balance function, gait ability, weight- distribution and weight-shifting BEHAVIORAL

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.

Healthy subjects; Stroke subjects

Weight- distribution and weight-shifting training program BEHAVIORAL

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.

Stroke subjects

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Li-Jiun Liaw

Kaohsiung City, Sanmin Dist, 80708, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Li-Jiun Liaw

  Kaohsiung Medical University Department of Physical Therapy Associate Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: April 12, 2021
• Study Start: February 25, 2016
• Primary Completion: September 19, 2018
• Study Completion: September 19, 2018
• Last Updated: April 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)