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

NCT ID: NCT04745481

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Trunk stabilization training device

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

Group Type EXPERIMENTAL

Trunk stabilization training device

Intervention Type DEVICE

Conventional rehabilitation 30min daily, 20times 4weeks

+Trunk stabilization training device 30min daily, 20time 4weeks

Conventional rehabilitation

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

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type DEVICE

Conventional rehabilitation 30min daily, 20times 4weeks

+Conventional rehabilitation 30min daily, 20times 4weeks

Interventions

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Trunk stabilization training device

Conventional rehabilitation 30min daily, 20times 4weeks

+Trunk stabilization training device 30min daily, 20time 4weeks

Intervention Type DEVICE

Conventional rehabilitation

Conventional rehabilitation 30min daily, 20times 4weeks

+Conventional rehabilitation 30min daily, 20times 4weeks

Intervention Type DEVICE

Other Intervention Names

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Balance Pro(SBT-330) Ergometer, Stepper

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pusan National University Yangsan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yong-il Shin

Head of Rehabilitation Medicine, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yong-il Shin, PhD

Role: STUDY_DIRECTOR

Pusan National University Yangsan Hospital

Locations

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Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, South Korea

Site Status

Countries

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South Korea

References

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Min JH, Seong HY, Ko SH, Jo WR, Sohn HJ, Ahn YH, Son JH, Seo HY, Son YR, Mun SJ, Ko MH, Shin YI. Effects of trunk stabilization training robot on postural control and gait in patients with chronic stroke: a randomized controlled trial. Int J Rehabil Res. 2020 Jun;43(2):159-166. doi: 10.1097/MRR.0000000000000399.

Reference Type BACKGROUND
PMID: 32282572 (View on PubMed)

Chung SH, Kim JH, Yong SY, Lee YH, Park JM, Kim SH, Lee HC. Effect of Task-Specific Lower Extremity Training on Cognitive and Gait Function in Stroke Patients: A Prospective Randomized Controlled Trial. Ann Rehabil Med. 2019 Feb;43(1):1-10. doi: 10.5535/arm.2019.43.1.1. Epub 2019 Feb 28.

Reference Type BACKGROUND
PMID: 30852865 (View on PubMed)

Other Identifiers

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03-2020-010

Identifier Type: -

Identifier Source: org_study_id

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