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

Primary Purpose

Hemiplegia, Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conservative rehabilitation
Virtual Balance Training
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Abant Izzet Baysal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conservative Rehabilitation

Conservative Rehabilitation + Virtual Balance Training

Arm Description

Only conservative rehabilitation treatment was applied to the patients in group 1.

Conservative rehabilitation treatment and virtual balance study were applied to the patients in group 2.

Outcomes

Primary Outcome Measures

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
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
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
Short Form-36 Quality of Life Scale
It consists of 36 questions filled by the individual himself. High scores indicate good quality of life.
Short Form-36 Quality of Life Scale
It consists of 36 questions filled by the individual himself. High scores indicate good quality of life.

Full Information

First Posted
September 21, 2022
Last Updated
September 21, 2022
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT05552742
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative Rehabilitation
Arm Type
Active Comparator
Arm Description
Only conservative rehabilitation treatment was applied to the patients in group 1.
Arm Title
Conservative Rehabilitation + Virtual Balance Training
Arm Type
Experimental
Arm Description
Conservative rehabilitation treatment and virtual balance study were applied to the patients in group 2.
Intervention Type
Other
Intervention Name(s)
Conservative rehabilitation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual Balance Training
Intervention Description
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 Outcome Measure Information:
Title
Berg Balance Scale
Description
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
Time Frame
Before Treatment
Title
Berg Balance Scale
Description
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
Time Frame
8 Week After Treatment
Title
Functional Ambulation Scale
Description
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.
Time Frame
Before Treatment
Title
Functional Ambulation Scale
Description
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.
Time Frame
8 Week After Treatment
Title
Static and Dynamic Postural Stability Tests
Description
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.
Time Frame
Before Treatment
Title
Static and Dynamic Postural Stability Tests
Description
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.
Time Frame
8 Week After Treatment
Secondary Outcome Measure Information:
Title
Brunnstrom Stages
Description
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.
Time Frame
Before Treatment
Title
Brunnstrom Stages
Description
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.
Time Frame
8 Week After Treatment
Title
The Modified Ashworth Scale
Description
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.
Time Frame
Before Treatment
Title
The Modified Ashworth Scale
Description
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.
Time Frame
8 Week After Treatment
Title
Short Form-36 Quality of Life Scale
Description
It consists of 36 questions filled by the individual himself. High scores indicate good quality of life.
Time Frame
Before Treatment
Title
Short Form-36 Quality of Life Scale
Description
It consists of 36 questions filled by the individual himself. High scores indicate good quality of life.
Time Frame
8 Week After Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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,
Facility Information:
Facility Name
Abant Izzet Baysal University
City
Bolu
ZIP/Postal Code
14100
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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