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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04841161
Enrollment
50
Registered
2021-04-12
Start date
2016-02-25
Completion date
2018-09-19
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

BEHAVIORALBalance 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.

BEHAVIORALWeight- 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.

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in performance of weight distribution after 8 sessions interventionThe assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)By using the force plate to record the ground reaction force and then to obtain weight distribution while performing the sit to stand activity
Changes in performance of standing balance after 8 sessions interventionThe assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)By using the force plate to obtain displacements of the center of pressure (COP) while standing and weight transfer
Changes in performance of static and dynamic balance after 8 sessions interventionThe assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)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.
Changes in performance of balance function after 8 sessions interventionThe assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)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.
Changes in performance of dynamic balance after 8 sessions interventionThe assessments will be conducted before and after intervention (4 Weeks, 8 Sessions)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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026