Stroke
Conditions
Keywords
trunk stabilization training
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.
Interventions
DEVICETrunk stabilization training device
Conventional rehabilitation 30min daily, 20times 4weeks +Trunk stabilization training device 30min daily, 20time 4weeks
DEVICEConventional rehabilitation
Conventional rehabilitation 30min daily, 20times 4weeks +Conventional rehabilitation 30min daily, 20times 4weeks
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Berg Balance Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go test | baseline and week 4 | The Timed Up and Go test(TUG) starts with sitting in a chair and measures the time it takes to get up and walk 3 meters back to sitting on the chair. |
| Functional Ambulation Category | baseline and week 4 | The Functional Ambulation Category(FAC) is a 7-point scale to evaluate the gait and mobility of patients with nervous and musculoskeletal injury. A higher score is interpreted as having higher independence of walking, and a score of 3 or less is considered difficult to move independently. It is a tool to evaluate not only balance ability but also actual mobility ability. |
| Korean version of Modified Barthel Index | baseline and week 4 | The Korean version of Modified Barthel Index(K-MBI) is a tool to evaluate the patient's level of independence in daily living activities, including basic daily living activities and instrumental daily living activities. It consists of 5 to 15 points depending on the item, and the perfect score is 100 points. The higher the score, the higher the patient's level of independence from daily activities is considered. |
| Fugl-Meyer Assessment(L/E) | baseline and week 4 | The Fugl-Meyer Assessment(FMA)(L/E) is an exercise ability scale to evaluate the motor function of stroke patients, and it is a tool to evaluate motor function of the healthy and injured upper and lower limbs. Each exercise item is evaluated on a 2-point scale and 3-point scale, with a perfect score of 100. In this study, lower limb evaluation items are implemented. |
| Trunk Impairment Scale | baseline and week 4 | The Trunk Impairment Scale(TIS) is for the motor impairment of the trunk of a stroke patient. As an optimal test method, it measures static and dynamic balance and coordination between the body in a sitting position. There are a total of 17 items with 3 items for static balance ability in a sitting position, 10 items for dynamic balance ability, and 4 items for trunk coordination, and minimum 0 to maximum 23 points. |
Countries
South Korea
Outcome results
None listed