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Comparison of The Effects of Virtual Balance Training and Conservative Rehabilitation Therapy in Stroke Patients

Not Applicable
Completed
Conditions
Hemiplegia
Stroke
Interventions
Other: Conservative rehabilitation
Device: Virtual Balance Training
Registration Number
NCT05552742
Lead Sponsor
Abant Izzet Baysal University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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,

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Conservative RehabilitationConservative rehabilitationOnly conservative rehabilitation treatment was applied to the patients in group 1.
Conservative Rehabilitation + Virtual Balance TrainingConservative rehabilitationConservative rehabilitation treatment and virtual balance study were applied to the patients in group 2.
Conservative Rehabilitation + Virtual Balance TrainingVirtual Balance TrainingConservative rehabilitation treatment and virtual balance study were applied to the patients in group 2.
Primary Outcome Measures
NameTimeMethod
Berg Balance Scale8 Week After Treatment

The BBS is used to objectively determine a patient's ability to balance safely during a predetermined set of tasks. The scale comprises 14 items. Each item receives a score ranging from 0 to 4, which is a five-point rank scale with 0 indicating the lowest level of functioning and 4 indicating the highest level of functioning

Static and Dynamic Postural Stability Tests8 Week After Treatment

In the static postural stability test, two-legged standing, tandem standing, two-legged standing on a foam mat, tandem standing on a foam mat, one-legged standing, turning head and stopping on one leg, and one-legged standing on a foam mat were evaluated. The tasks of walking 25 steps on a foam mat and walking 25 steps on hard smooth ground were evaluated in dynamic postural stability test.

Functional Ambulation Scale8 Week After Treatment

Functional Ambulation Scale is a 6-point functional walking test that evaluates ambulation ability and determines the amount of human support required by patients while walking, regardless of whether they use a personal assistive device. A score of 0 indicates that the patient has a dysfunctional ambulation A score of 5 denotes independent ambulation on any surface.

Secondary Outcome Measures
NameTimeMethod
Brunnstrom Stages8 Week After Treatment

Brunnstrom stages is a scale used to assess motor recovery after a stroke, which is expressed using values between 1 and 6. The higher the value on this scale, the higher would be the recovery.

The Modified Ashworth Scale8 Week After Treatment

The modified Ashworth Scale is used to evaluate spasticity in patients after stroke, which is expressed using values between 0 and 4. The higher the value on this scale, the higher would be the spasticity.

Short Form-36 Quality of Life Scale8 Week After Treatment

It consists of 36 questions filled by the individual himself. High scores indicate good quality of life.

Trial Locations

Locations (1)

Abant Izzet Baysal University

🇹🇷

Bolu, Turkey

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