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Completed

NCT Number: NCT04841161

Development of an Intelligent Balance Training System Providing Weight-bearing Feedback 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.

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Key information

Conditions

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

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Li-Jiun Liaw

Kaohsiung City, Sanmin Dist, 80708, Taiwan

About this study

  • Written informed consent must be obtained before any study specific procedures are undertaken.
  • 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.
  • 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.
  • The process of the experiment (brief describe)
  • Written informed consent must be obtained before any study specific procedures are undertaken.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Changes in performance of weight distribution after 8 sessions intervention

    Time frame: The 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

  2. Changes in performance of standing balance after 8 sessions intervention

    Time frame: The 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

  3. Changes in performance of static and dynamic balance after 8 sessions intervention

    Time frame: The 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.

  4. Changes in performance of balance function after 8 sessions intervention

    Time frame: The 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.

  5. Changes in performance of dynamic balance after 8 sessions intervention

    Time frame: The 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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2021
Registry last updated
Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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