Clinical trial NCT05552742: Comparison of The Effects of Virtual Balance Training and Conservative Rehabilitation Therapy in Stroke Patients
Official title: Comparison of The Effects of Virtual Balance Training and Conservative Rehabilitation Therapy on Balance in Stroke Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Stroke
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to assess the effects of a virtual balance training program using the Thera-Trainer Balo (TTB) device along with conservative rehabilitation program on the clinical findings; standing, stepping, walking and balance measures; and activities of daily living in patients with stroke.

Detailed description: Stroke is one of the leading causes of death and disability worldwide. Approximately 71% of stroke cases occur as a result of ischemic infarcts. Most survivors of stroke experience gait and balance disorders that increase the risk of falling.

It has been shown that the functional recovery of patients with stroke is adversely affected and length of hospital stay during the rehabilitation program, particularly in those with severe balance disorders.

Virtual reality technologies are currently employed to accelerate functional recovery in patients.

A total of 30 patients were included in the study. The patients were randomized into two groups with 15 patients in each group by simple randomization.

Group 1 received the conservative rehabilitation program, whereas Group 2 received a balance training program using the Thera-Trainer Balo (TTB) device along with the conservative rehabilitation program.

Patient information regarding the age, gender, hemiplegic side, stroke duration, and type of ischemia were recorded. The stage of motor recovery according to Brunnstrom, spasticity based on the modified Ashworth scale, ambulation ability based on the Functional Ambulation Scale (FAS), quality of life based on the Short Form-36 (SF-36) scale, and balance-coordination status based on the Berg Balance Scale (BBS) were assessed at the beginning of the treatment and at the endpoint of the 8 week treatment. Moreover, evaluations were made with static and dynamic postural stability tests.

The study aimed to assess the effects of a virtual balance training program using the Thera-Trainer Balo (TTB) device along with conservative rehabilitation program on the clinical findings; standing, stepping, walking and balance measures; and activities of daily living in patients with stroke.

Eligibility criteria: Inclusion Criteria:

* patients who had a cerebrovascular accident at least 6 months before the study,
* patients had the first unilateral hemiparesis attack, could stand with or without assistance,
* patients had no contraindications for walking.

Exclusion Criteria:

* patients with a history of neurological diseases,
* a mini-mental test score of \<24,
* severe spasticity at the lower extremity with grade 4 and unilateral neglect, and musculoskeletal diseases such as amputation and severe arthritis, which limits walking,

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Before Treatment
measure: Berg Balance Scale
timeFrame: 8 Week After Treatment
measure: Functional Ambulation Scale
timeFrame: Before Treatment
measure: Functional Ambulation Scale
timeFrame: 8 Week After Treatment
measure: Static and Dynamic Postural Stability Tests
timeFrame: Before Treatment
measure: Static and Dynamic Postural Stability Tests
timeFrame: 8 Week After Treatment
Secondary outcomes:
measure: Brunnstrom Stages
timeFrame: Before Treatment
measure: Brunnstrom Stages
timeFrame: 8 Week After Treatment
measure: The Modified Ashworth Scale
timeFrame: Before Treatment
measure: The Modified Ashworth Scale
timeFrame: 8 Week After Treatment
measure: Short Form-36 Quality of Life Scale
timeFrame: Before Treatment
measure: Short Form-36 Quality of Life Scale
timeFrame: 8 Week After Treatment
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
Study officials:
References: