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

Kaohsiung Medical University

Status: Completed

Conditions: Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04841161

KMUHIRB-F(II)-20150033

Details and patient eligibility

About

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.

Full description

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

2. 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.

3. 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.

4. The process of the experiment (brief describe)

5. Written informed consent must be obtained before any study specific procedures are undertaken.

6. 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.

7. 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.

Enrollment: 50 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Healthy subjects

Other group

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.

Treatment:

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

Stroke subjects

Experimental group

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.

Treatment:

Behavioral: Weight- distribution and weight-shifting training program

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