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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05552742
• Other study ID #: AIBU-FTR-SK-04
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: September 2022
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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,

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Other:
• Conservative rehabilitation
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.

Device:
• Virtual Balance Training
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

Locations

Country	Name	City	State
Turkey	Abant Izzet Baysal University	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale	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	Before Treatment
Primary	Berg Balance Scale	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	8 Week After Treatment
Primary	Functional Ambulation Scale	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.	Before Treatment
Primary	Functional Ambulation Scale	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.	8 Week After Treatment
Primary	Static and Dynamic Postural Stability Tests	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.	Before Treatment
Primary	Static and Dynamic Postural Stability Tests	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.	8 Week After Treatment
Secondary	Brunnstrom Stages	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.	Before Treatment
Secondary	Brunnstrom Stages	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.	8 Week After Treatment
Secondary	The Modified Ashworth Scale	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.	Before Treatment
Secondary	The Modified Ashworth Scale	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.	8 Week After Treatment
Secondary	Short Form-36 Quality of Life Scale	It consists of 36 questions filled by the individual himself. High scores indicate good quality of life.	Before Treatment
Secondary	Short Form-36 Quality of Life Scale	It consists of 36 questions filled by the individual himself. High scores indicate good quality of life.	8 Week After Treatment