Effects of Trunk Stabilization Training Device on Balance Ability for Stroke Patients

Pusan National University Yangsan Hospital

Status: Completed

Conditions: Stroke

Treatments: Device: Conventional rehabilitation; Device: Trunk stabilization training device

Study type: Interventional

Funder types: Other

Identifiers

NCT04745481

03-2020-010

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 2 patient groups

Trunk stabilization training device

Experimental group

Description:

Participants will receive conventional rehabilitation and use trunk stabilization training device 30min each daily, 20 times for 4weeks.

Treatment:

Device: Trunk stabilization training device

Conventional rehabilitation

Active Comparator group

Description:

Participants will receive conventional rehabilitation 60min daily, 20times for 4weeks.

Treatment:

Device: Conventional rehabilitation