Clinical trial NCT06166004: The Effects of Balance Trainer
Official title: The Effects of Balance Trainer-Based Training on Balance and Trunk Control in Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Virtual Reality
Keywords: Stroke
Virtual Reality
Balance-Trainer
Thera-Trainer
Rehabilitation Technologies
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Stroke is one of the leading causes of death in adults and significantly contributes to severe disability. Balance problems are among the most common issues following a stroke, affecting the patient's ability to sit, stand, transfer, and walk, thereby posing a risk of falls. Balance rehabilitation can be instrumental in addressing these challenges. For instance, clinicians may decide to allocate more time to safe transfers or wheelchair skills for individuals with a Berg Balance Scale (BBS) score below 12. Conversely, those scoring 29 or higher on the BBS may warrant an increase in the intensity and duration of walking training, as they are likely to progress to community-appropriate walking speeds.

The trunk, located at the body's center, plays a crucial role in organizing postural control and balance reactions. A healthy trunk is essential for the successful execution of both lower and upper extremity functions. Trunk control is necessary to provide a stable support base during the execution of lower and upper extremity movements, requiring active involvement of the trunk in daily life activities such as reaching.

The Balance-Trainer is a technology-based biofeedback-controlled system used in individuals with Multiple Sclerosis, Stroke, Muscle Diseases, and geriatric populations. The device includes balance exercises involving weight shifting in different directions through games like Collect Apples, Outline, Paddle War, and Evaluation of Movement. Reviewing the literature reveals that exercise devices incorporating virtual reality are effective in improving balance.

The research, designed as a prospective study with two parallel groups, aims to investigate the effects of balance training with the Balance-Trainer (BT) on trunk control, balance, and fall risk in stroke patients. The hypothesis is that balance training with BT will positively impact trunk control and balance. The study population consists of patients undergoing treatment for stroke (ICD.10 G.81 Hemiplegia) at Ankara City Hospital Physical Therapy and Rehabilitation Hospital.

Volunteers meeting the inclusion criteria from stroke patients receiving treatment at Ankara City Hospital Physical Therapy and Rehabilitation Hospital will be enrolled in the research. Participants involved in the study will continue their standard rehabilitation program. Those directed by their physician for BT will be included in the study group, while stroke patients voluntarily not receiving balance training with BT during their stroke clinic treatments will be included in the control group.

Both study and control groups in the research will continue individualized rehabilitation programs for three weeks, five days a week. This program includes stretching and strengthening exercises, mat activities such as bridging, joint range of motion exercises, static and dynamic balance exercises, and walking exercises. Exercises are selected based on the patient's needs. In addition to the individualized rehabilitation program, the study group will engage in 15 sessions of BT balance exercises over three weeks, with five sessions per week and each session lasting 30 minutes.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Trunk Imapirment Scale
timeFrame: Baseline and 3 weeks later
measure: Berg Balance Scale
timeFrame: Baseline and 3 weeks later
Secondary outcomes:
measure: Functional Independence Measure
timeFrame: Baseline and 3 weeks later
measure: Falls Efficacy Scale-International
timeFrame: Baseline and 3 weeks later
measure: Functional Ambulation Category
timeFrame: Baseline and 3 weeks later
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
state: Çankaya
Study officials:
References: