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

NCT ID: NCT04841161

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-25
• Study Completion Date: 2018-09-19

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.

Conditions

Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

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

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Weight- distribution and weight-shifting training program

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li-Jiun Liaw

Role: STUDY_DIRECTOR

Kaohsiung Medical University Department of Physical Therapy Associate Professor

Locations

Li-Jiun Liaw

Kaohsiung City, Sanmin Dist, Taiwan

Countries

Taiwan

Other Identifiers

KMUHIRB-F(II)-20150033

Identifier Type: -

Identifier Source: org_study_id