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Completed

NCT Number: NCT05552742

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

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.

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Key information

Conditions

Hemiplegia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abant Izzet Baysal University

Bolu, 14100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Conservative rehabilitation

Other

The conservative rehabilitation program includes a patient-specific conservative exercise program comprising exercises that strengthen the paralyzed side, increase joint range of motion and strengthen muscles, stretch spastic muscles, and ensure balance rehabilitation that enhances balance performance and coordination. The patients in both groups received conservative rehabilitation program for 8 weeks, 4 days a week for 1 h.

Virtual Balance Training

Device

Virtual balance training program using the Thera-Trainer Balo device was applied 4 times a week for a total of 8 weeks, and each session lasted for 20 min. The center of mass of each patient was determined using sensors and displayed on the screen. The patients were encouraged to move their mass by swiping in all directions via the apple picking game displayed on the screen

Primary outcomes

  1. Berg Balance Scale

    Time frame: Before 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

  2. Berg Balance Scale

    Time frame: 8 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

  3. Functional Ambulation Scale

    Time frame: Before 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.

  4. Functional Ambulation Scale

    Time frame: 8 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.

  5. Static and Dynamic Postural Stability Tests

    Time frame: Before 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.

  6. Static and Dynamic Postural Stability Tests

    Time frame: 8 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.

Secondary outcomes

  1. Brunnstrom Stages

    Time frame: Before 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.

  2. Brunnstrom Stages

    Time frame: 8 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.

  3. The Modified Ashworth Scale

    Time frame: Before 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.

  4. The Modified Ashworth Scale

    Time frame: 8 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.

  5. Short Form-36 Quality of Life Scale

    Time frame: Before Treatment

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

  6. Short Form-36 Quality of Life Scale

    Time frame: 8 Week After Treatment

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

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 23, 2022
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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