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

NCT04745481 | Completed

• 1 other identifier: 03-2020-010
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke

Keywords

trunk stabilization training

Outcome Measures

Primary Outcomes (1)

• Change of Berg Balance Scale

  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.

  Change from baseline Berg Balance Scale at week 4

Secondary Outcomes (5)

• Timed Up and Go test

  baseline and week 4

• Functional Ambulation Category

  baseline and week 4

• Korean version of Modified Barthel Index

  baseline and week 4

• Fugl-Meyer Assessment(L/E)

  baseline and week 4

• Trunk Impairment Scale

  baseline and week 4

Study Arms (2)

Trunk stabilization training device

EXPERIMENTAL

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

Device: Trunk stabilization training device

Conventional rehabilitation

ACTIVE COMPARATOR

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

Device: Conventional rehabilitation

Interventions

Trunk stabilization training device DEVICE

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

Also known as: Balance Pro(SBT-330)

Trunk stabilization training device

Conventional rehabilitation DEVICE

Conventional rehabilitation 30min daily, 20times 4weeks +Conventional rehabilitation 30min daily, 20times 4weeks

Also known as: Ergometer, Stepper

Conventional rehabilitation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, 50610, South Korea

Location

Related Publications (2)

• 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.

  PMID: 32282572 BACKGROUND

• 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.

  PMID: 30852865 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Yong-il Shin, PhD

  Pusan National University Yangsan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rehabilitation Medicine, Principal Investigator

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 9, 2021
• Study Start: March 15, 2021
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)