The Effects of Balance Trainer

NCT06166004 | Completed

• 1 other identifier: BT01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The trunk is reference and key region of body in terms of both mobility and stability. Sufficient stability in the trunk is essential for the execution of intentional extremity movements. Therefore, even in conditions with significant extremity impairment, such as stroke, trunk functionality is a crucial factor affecting the success of treatment. The Balance Trainer is a device used for balance rehabilitation. However, the patient's use of the trunk is also intense during trunk exercises. The aim of the study is to contribute to the literature by examining the development of trunk control, a component of both balance and stability, through the use of the Balance Trainer.

Conditions

Stroke; Virtual Reality

Keywords

Stroke; Virtual Reality; Balance-Trainer; Thera-Trainer; Rehabilitation Technologies

Outcome Measures

Primary Outcomes (2)

• Trunk Imapirment Scale

  It is a standardized scale designed for assessing the trunk after a stroke. It consists of three sections: static sitting balance, dynamic sitting balance, and coordination, with a maximum score of 23. In our research, it will be utilized to evaluate patients' trunk control after a stroke.

  Baseline and 3 weeks later

• Berg Balance Scale

  This is a simple and safe balance test designed to measure an individual's ability to maintain balance while performing functional tasks. The person is asked to perform 14 tasks, and scores are given based on the completion of each task. A score of 0 is assigned when the activity is not performed at all, while a score of 4 is given when the activity is completed independently. The highest possible score is 56, with 0-20 indicating balance impairment, 21-40 suggesting an acceptable balance, and 41-56 indicating good balance.

  Baseline and 3 weeks later

Secondary Outcomes (3)

• Functional Independence Measure

  Baseline and 3 weeks later

• Falls Efficacy Scale-International

  Baseline and 3 weeks later

• Functional Ambulation Category

  Baseline and 3 weeks later

Study Arms (2)

BalanceTrainer

EXPERIMENTAL

Balance Trainer Exercises (30 min) Person-Specific Rehabilitation Program 1. Stretching and Strengthening Exercises 2. Mat Activities 3. Joint Range of Motion Exercises 4. Static and Dynamic Balance Exercises 5. Walking Exercises

Other: Balance Training; Other: Person-Specific Rehabilitation Program

Control Group

OTHER

Person-Specific Rehabilitation Program 1. Stretching and Strengthening Exercises 2. Mat Activities 3. Joint Range of Motion Exercises 4. Static and Dynamic Balance Exercises 5. Walking Exercises

Other: Person-Specific Rehabilitation Program

Interventions

Balance Training OTHER

Balance Training device with VR

Also known as: Thera Trainer Balo

BalanceTrainer

Person-Specific Rehabilitation Program OTHER

Person-Specific Rehabilitation Program

BalanceTrainer; Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having the ICD-10 diagnosis code G.81 Hemiplegia
• At least 3 weeks having passed since the diagnosis (Subacute and later periods)
• Being 18 years of age or older
• Having a Berg Balance Score between 21-40 (indicating an acceptable balance)

You may not qualify if:

• Having a known additional neurological or orthopedic problem that could affect balance
• Not being cognitively able to understand and perform exercises
• Having a diagnosis date that is more than 2 years from the initial evaluation date

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara City Hospital

Ankara, Çankaya, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 12, 2023
• Study Start: August 23, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: February 20, 2025

Record last verified: 2023-12

Locations

TU (1)