Effectiveness Evaluation of Trunk Stabilization Training Using Balance Pro(SBT-330) for Stroke Patients With Reduced Balance Ability
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Change of Berg Balance Scale
Study Overview
Brief Summary
The purpose of this study is to assess the effectiveness of Balance pro(SBT-330:trunk stabilization training device) for stroke patients reduced balance ability
Detailed Description
after being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. Subjects who pass the screening test will randomize in a 1:1 ratio to experimental group(conventional rehabilitation + trunk stabilization training device, 30min each, 20days) or control group(conventional rehabilitation + conventional rehabilitation, 30min each, 20days). And then, They receive a registration number within 7 days and proceed with the pre-intervention test.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Stroke patients 40 years or older (within 2 years of onset)
- •Those who have no problems with visual function in conducting and conducting clinical trials
- •Patients who are found to have decreased balance ability after stroke (BBS score is 21-40 points)
- •Those who do not have orthopedic diseases in both lower limbs
- •Subjects with cognitive functions capable of fulfilling and carrying out instructions
- •Those who voluntarily consent to the clinical trial
Exclusion Criteria
- •Subjects with intellectual disabilities to the extent that they are unable to perform instructions
- •Subjects taking drugs that may affect the study
- •Subjects with skin and musculoskeletal abnormalities for which the device cannot be worn
- •Patients with neurological disorders other than stroke and other disorders that may affect balance
- •Other subjects who are judged to be unsuitable for this study
Arms & Interventions
Conventional rehabilitation
Participants will receive conventional rehabilitation 60min daily, 20times for 4weeks.
Intervention: Conventional rehabilitation (Device)
Trunk stabilization training device
Participants will receive conventional rehabilitation and use trunk stabilization training device 30min each daily, 20 times for 4weeks.
Intervention: Trunk stabilization training device (Device)
Outcomes
Primary Outcomes
Change of Berg Balance Scale
Time Frame: Change from baseline Berg Balance Scale at week 4
The Berg Balance Scale(BBS) is the quantified cutoff values for the four basic gait-related activities of stroke patients. It consists of a total of 14 items, and each item is divided into 5 levels, ranging from 0 to 4 points, with a total score of 56 points. Interpretation of exercise state according to score is 0-20: Wheelchair bound. 21-40: Walking with assistance. 41-56: independent.
Secondary Outcomes
- Fugl-Meyer Assessment(L/E)(baseline and week 4)
- Functional Ambulation Category(baseline and week 4)
- Trunk Impairment Scale(baseline and week 4)
- Timed Up and Go test(baseline and week 4)
- Korean version of Modified Barthel Index(baseline and week 4)
Investigators
Yong-il Shin
Head of Rehabilitation Medicine, Principal Investigator
Pusan National University Yangsan Hospital