search
Back to results

The Comparison of Virtual and Real Boxing Training in Hemiparetic Stroke Patients

Primary Purpose

Stroke, Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
real boxing training
virtual boxing training
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring virtual reality, boxing, upper extremity function, cognitive function, balance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with first time ever stroke
  • Patients with hemiparesis
  • Patients who are between the ages of 18-70
  • Patients who has Mini Mental Test score above 23
  • Patients whose functional level is less than 4 according to the Modified Rankin Scale
  • Patients who has upper extremity spasticity lower than 3 on Modified Ashworth Scale

Exclusion Criteria:

  • Hypertension
  • Heart disease
  • Subluxation and fracture at the shoulder
  • Visual impairment
  • Limitation in passive normal joint movement in hemiplegic side
  • Botulinum toxin administration or surgical operation in the last 6 months patients

Sites / Locations

  • Eastern Mediterranean University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

real boxing group

virtual boxing group

Arm Description

In the real boxing (RB) group in addition to the NDT program, real boxing training will be given.

In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing.

Outcomes

Primary Outcome Measures

Wolf Motor Function Test
Wolf Motor Function Test (WFMT) quantifies upper extremity motor ability through the use of timed and functional tasks. The widely used version of the WMFT consists of 17 items, items 7 and 14 are related to subject strength and the other 15 to subject functional ability during various tasks. Performances are scored using a 6-point functional ability scale and the less affected upper extremity followed by the most affected side. The total score, also referred to as Functional Ability score (WMFT-FAS), is the sum of the 15 items score (with a 6-point ordinal score from 0 to 5). The maximum total score is 75 and minimum is 0. Lower scores indicating lower functional levels.

Secondary Outcome Measures

Minnesota Manual Dexterity Test
Minnesota Manual Dexterity Test (MMDT) measures the speed of gross arm and hand movements (arm-hand dexterity) during rapid eye-hand coordination tasks. The MMDT involve five subtests:The Placing Test (1st item: taking the blocks with one hand and putting them in the holes on the board in a standardized order) and Two-hand Turning and Placing Test (5th item: taking the blocks with two hands and putting them in the holes on the board in a standardized order) were the two items selected for this study.The number of seconds it took to complete the task on each of the trials was recorded. The lower the score, the better the outcome.
Video Boxing Analysis of Punching
Video Boxing Analysis (VBA) evaluation method was used to evaluate the goal-oriented performance analysis of upper extremity. For boxing analysis patients were videotaped while punching with their right side, punching with side left and punching bilaterally. Than the videotape were watched to analyze and the number of right unilateral punches in 1 minute, number of left unilateral punches in 1 minute and number of bilateral punches in 1 minute were recorded. This analysis were done for the quantitative assessment of punch number per minute (number of punch/minute). This measurement method is created and constructed by the authors of this study. Higher number of punches indicate better outcome on this analysis.
Fullerton Advanced Balance Scale
Fullerton Advanced Balance (FAB) scale was developed to evaluate sensitive changes in many aspects of balance. This performance-based scale consists of 10 test items assessing functional balance (static and dynamic) status in older people. The individual test items are: 1. Feet together, eyes closed, 2. Reach forward to retrieve an object, 3. Turn in a full circle, 4. Step up and over a bench, 5. Tandem walk, 6. Stand on one leg, 7. Stand on foam, eyes closed, 8. Two-footed jump, 9. Walk with head turns, 10. Reactive postural control. Each test item is scored using a 0-4 scale. The highest score that can be obtained on this multidimensional balance assessment is 40 points, and the lowest is zero. Higher scores indicate better balance abilities. The FAB scale is quick to administer (~10-12 minutes) and can be administered in a relatively small area.
Addenbrooke's Cognitive Assessment
Addenbrook's Cognitive Assessment - Revised (ACE-R) is sensitive in the differential diagnosis of early stage dementia. However, the design and psychometric properties is also suitable to provide information about cognitive functions and cognitive deficits in patients without dementia after a stroke. The ACE-R consists of five domains including attention/orientation, memory, verbal fluency, language and visuospatial ability. The ACE-R total scale score ranges from 0 to 100. The ACE-R subscale scores ranges between; 0-18 points for attention, 0-26 for memory, 0-14 for fluency, 0-26 for language and 0-16 for visuospatial processing. Higher scores indicate better cognitive functioning. ACE- R scale was found as reliable and valid in Turkish population.
Frenchay Activities Index
Frenchay Activities Index is a measure of instrumental activities of daily living (IADL) for use with patients recovering from stroke. The Frenchay Activities Index (FAI) assesses a broad range of activities associated with everyday life. The benefit of the FAI is that while activities of daily living scales tend to focus on issues related to self-care and mobility. The FAI comprises 15 activities, each of which is scored on a 4-point scale (0 to 3), to yield a total score ranging from 0 (inactive) to 45 (active). Scoring is based on the frequency with which the activities are carried out. It can be broken down into three subscales: domestic chores, leisure/work, and outdoor activities. Each subscale's score ranges from 0 to 15.

Full Information

First Posted
August 10, 2018
Last Updated
November 29, 2021
Sponsor
Eastern Mediterranean University
search

1. Study Identification

Unique Protocol Identification Number
NCT03651479
Brief Title
The Comparison of Virtual and Real Boxing Training in Hemiparetic Stroke Patients
Official Title
The Comparison of Virtual and Real Boxing Training in Hemiparetic Stroke Patients: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 10, 2018 (Actual)
Primary Completion Date
June 12, 2019 (Actual)
Study Completion Date
June 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean 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 aim of this study is to compare the effects of virtual and real boxing training in addition to neurodevelopmental training on cognitive status, upper extremity functions, balance and activities of daily living in hemiparetic stroke patients.
Detailed Description
The use of computer systems has become a highly accepted approach in neurorehabilitation currently. Virtual reality (VR) is frequently used in different disease groups for this purpose. By using various VR equipment (sensors, balance board, control, etc.), exercises can be individualized to suit individual needs and aim to stimulate neural plasticity according to motor learning principles with repetitive activities. In recent years, it has been observed that boxing training (boxing therapy) in individuals with neurological diseases (e.g. Parkinson's disease and stroke) gives positive results. It has been shown in the literature there are short and long-term improvement in daily life activities, quality of life, balance and gait functions after boxing training in patients with Parkinson' disease despite the progressive nature of Parkinson's disease. Additionally it was found that boxing program in sitting has positive effects on upper extremity functions, balance, walking and quality of life in stroke patients. In the literature, there were no studies comparing virtual and boxing therapy in stroke patients. Therefore, the aim of this study is to compare the effects of virtual and real boxing training in addition to neurodevelopmental training (NDT) on cognitive status, upper extremity functions, balance and activities of daily living in hemiparetic stroke patients. Patients who have had a stroke for the first time with hemiparesis, who are between the ages of 18-70, who has Mini Mental Test score above 23, whose functional level is less than 4 according to the Modified Rankin Scale, who has upper extremity spasticity lower than 3 on Modified Ashworth Scale will be included in this study. In case of hypertension which may prevent rehabilitation, heart disease, subluxation and fracture at the shoulder, visual impairment, limitation in passive normal joint movement in hemiplegic side, botulinum toxin administration or surgical operation in the last 6 months patients will not be excluded. All the patients will be measured with Addenbrooke's Cognitive Assessment (ACA), Minnesota Hand Skill Test, Wolf Motor Function Test (WMFT), Fullerton Advanced Balance Scale (FAB), Frenchay Activity Index (FAI) and video boxing analysis of punching.The measurements will be made at the beginning of the treatment (0 weeks) and at the end of the treatment (8 weeks). NDT approaches consist of upper extremity facilitation techniques and activities in accordance with the patient's functional level, weight transfer and walking exercises to increase sitting and standing balance, mat exercises with the same purpose considering the functional level for each patient. In the real boxing (RB) group in addition to the NDT program, real boxing training will be given. Accordingly, the physiotherapist and the patient will wear boxing gloves and the patients will punch the physiotherapist's glove with a pre-specified treatment protocol. Resistance and frequencies between levels will be increased by the physiotherapist as the sessions progress. The RB group will have 30 minutes of real boxing training for 3 sessions per week for 8 weeks. In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing. For the VB group, virtual boxing training will be held for 3 weeks 30 minutes a week for 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
virtual reality, boxing, upper extremity function, cognitive function, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
real boxing group
Arm Type
Experimental
Arm Description
In the real boxing (RB) group in addition to the NDT program, real boxing training will be given.
Arm Title
virtual boxing group
Arm Type
Experimental
Arm Description
In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing.
Intervention Type
Other
Intervention Name(s)
real boxing training
Intervention Description
In the real boxing (RB) group in addition to the NDT program, real boxing training will be given. Accordingly, the physiotherapist and the patient will wear boxing gloves and the patients will punch the physiotherapist's glove with a pre-specified treatment protocol. Resistance and frequencies between levels will be increased by the physiotherapist as the sessions progress. The RB group will have 30 minutes of real boxing training for 3 sessions per week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
virtual boxing training
Intervention Description
In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing. For the VB group, virtual boxing training will be held for 3 weeks 30 minutes a week for 8 weeks.
Primary Outcome Measure Information:
Title
Wolf Motor Function Test
Description
Wolf Motor Function Test (WFMT) quantifies upper extremity motor ability through the use of timed and functional tasks. The widely used version of the WMFT consists of 17 items, items 7 and 14 are related to subject strength and the other 15 to subject functional ability during various tasks. Performances are scored using a 6-point functional ability scale and the less affected upper extremity followed by the most affected side. The total score, also referred to as Functional Ability score (WMFT-FAS), is the sum of the 15 items score (with a 6-point ordinal score from 0 to 5). The maximum total score is 75 and minimum is 0. Lower scores indicating lower functional levels.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Minnesota Manual Dexterity Test
Description
Minnesota Manual Dexterity Test (MMDT) measures the speed of gross arm and hand movements (arm-hand dexterity) during rapid eye-hand coordination tasks. The MMDT involve five subtests:The Placing Test (1st item: taking the blocks with one hand and putting them in the holes on the board in a standardized order) and Two-hand Turning and Placing Test (5th item: taking the blocks with two hands and putting them in the holes on the board in a standardized order) were the two items selected for this study.The number of seconds it took to complete the task on each of the trials was recorded. The lower the score, the better the outcome.
Time Frame
8 weeks
Title
Video Boxing Analysis of Punching
Description
Video Boxing Analysis (VBA) evaluation method was used to evaluate the goal-oriented performance analysis of upper extremity. For boxing analysis patients were videotaped while punching with their right side, punching with side left and punching bilaterally. Than the videotape were watched to analyze and the number of right unilateral punches in 1 minute, number of left unilateral punches in 1 minute and number of bilateral punches in 1 minute were recorded. This analysis were done for the quantitative assessment of punch number per minute (number of punch/minute). This measurement method is created and constructed by the authors of this study. Higher number of punches indicate better outcome on this analysis.
Time Frame
8 weeks
Title
Fullerton Advanced Balance Scale
Description
Fullerton Advanced Balance (FAB) scale was developed to evaluate sensitive changes in many aspects of balance. This performance-based scale consists of 10 test items assessing functional balance (static and dynamic) status in older people. The individual test items are: 1. Feet together, eyes closed, 2. Reach forward to retrieve an object, 3. Turn in a full circle, 4. Step up and over a bench, 5. Tandem walk, 6. Stand on one leg, 7. Stand on foam, eyes closed, 8. Two-footed jump, 9. Walk with head turns, 10. Reactive postural control. Each test item is scored using a 0-4 scale. The highest score that can be obtained on this multidimensional balance assessment is 40 points, and the lowest is zero. Higher scores indicate better balance abilities. The FAB scale is quick to administer (~10-12 minutes) and can be administered in a relatively small area.
Time Frame
8 weeks
Title
Addenbrooke's Cognitive Assessment
Description
Addenbrook's Cognitive Assessment - Revised (ACE-R) is sensitive in the differential diagnosis of early stage dementia. However, the design and psychometric properties is also suitable to provide information about cognitive functions and cognitive deficits in patients without dementia after a stroke. The ACE-R consists of five domains including attention/orientation, memory, verbal fluency, language and visuospatial ability. The ACE-R total scale score ranges from 0 to 100. The ACE-R subscale scores ranges between; 0-18 points for attention, 0-26 for memory, 0-14 for fluency, 0-26 for language and 0-16 for visuospatial processing. Higher scores indicate better cognitive functioning. ACE- R scale was found as reliable and valid in Turkish population.
Time Frame
8 weeks
Title
Frenchay Activities Index
Description
Frenchay Activities Index is a measure of instrumental activities of daily living (IADL) for use with patients recovering from stroke. The Frenchay Activities Index (FAI) assesses a broad range of activities associated with everyday life. The benefit of the FAI is that while activities of daily living scales tend to focus on issues related to self-care and mobility. The FAI comprises 15 activities, each of which is scored on a 4-point scale (0 to 3), to yield a total score ranging from 0 (inactive) to 45 (active). Scoring is based on the frequency with which the activities are carried out. It can be broken down into three subscales: domestic chores, leisure/work, and outdoor activities. Each subscale's score ranges from 0 to 15.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with first time ever stroke Patients with hemiparesis Patients who are between the ages of 18-70 Patients who has Mini Mental Test score above 23 Patients whose functional level is less than 4 according to the Modified Rankin Scale Patients who has upper extremity spasticity lower than 3 on Modified Ashworth Scale Exclusion Criteria: Hypertension Heart disease Subluxation and fracture at the shoulder Visual impairment Limitation in passive normal joint movement in hemiplegic side Botulinum toxin administration or surgical operation in the last 6 months patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gozde Iyigun, PhD
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Mediterranean University
City
Famagusta
State/Province
North Cyprus Via Mersin 10 Turkey
ZIP/Postal Code
99450
Country
Cyprus

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27792020
Citation
Park J, Gong J, Yim J. Effects of a sitting boxing program on upper limb function, balance, gait, and quality of life in stroke patients. NeuroRehabilitation. 2017;40(1):77-86. doi: 10.3233/NRE-161392.
Results Reference
background
PubMed Identifier
24051993
Citation
Sin H, Lee G. Additional virtual reality training using Xbox Kinect in stroke survivors with hemiplegia. Am J Phys Med Rehabil. 2013 Oct;92(10):871-80. doi: 10.1097/PHM.0b013e3182a38e40.
Results Reference
background

Learn more about this trial

The Comparison of Virtual and Real Boxing Training in Hemiparetic Stroke Patients

We'll reach out to this number within 24 hrs