Trial Outcomes & Findings for The Comparison of Virtual and Real Boxing Training in Hemiparetic Stroke Patients (NCT NCT03651479)
NCT ID: NCT03651479
Last Updated: 2021-11-30
Results Overview
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.
COMPLETED
NA
40 participants
8 weeks
2021-11-30
Participant Flow
Participant milestones
| Measure |
Real Boxing Group
In the real boxing (RB) group in addition to the NDT program, real boxing training will be given.
real boxing training: 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.
|
Virtual Boxing Group
In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing.
virtual boxing training: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Real Boxing Group
n=20 Participants
In the real boxing (RB) group in addition to the NDT program, real boxing training will be given.
real boxing training: 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.
|
Virtual Boxing Group
n=20 Participants
In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing.
virtual boxing training: 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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
28 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Age, Continuous
|
58.25 years
STANDARD_DEVIATION 11.19 • n=20 Participants
|
60.15 years
STANDARD_DEVIATION 10.19 • n=20 Participants
|
59.20 years
STANDARD_DEVIATION 10.61 • n=40 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
27 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Cyprus
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
40 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 8 weeksWolf 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.
Outcome measures
| Measure |
Real Boxing Group
n=20 Participants
In the real boxing (RB) group in addition to the NDT program, real boxing training will be given.
real boxing training: 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.
|
Virtual Boxing Group
n=20 Participants
In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing.
virtual boxing training: 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.
|
|---|---|---|
|
Wolf Motor Function Test
baseline
|
68.00 score on a scale
Standard Deviation 9.46
|
69.65 score on a scale
Standard Deviation 3.12
|
|
Wolf Motor Function Test
after treatment
|
68.65 score on a scale
Standard Deviation 3.12
|
71.05 score on a scale
Standard Deviation 2.56
|
SECONDARY outcome
Timeframe: 8 weeksMinnesota 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.
Outcome measures
| Measure |
Real Boxing Group
n=20 Participants
In the real boxing (RB) group in addition to the NDT program, real boxing training will be given.
real boxing training: 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.
|
Virtual Boxing Group
n=20 Participants
In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing.
virtual boxing training: 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.
|
|---|---|---|
|
Minnesota Manual Dexterity Test
|
3.39 seconds
Standard Deviation 2.53
|
2.42 seconds
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: 8 weeksVideo 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.
Outcome measures
| Measure |
Real Boxing Group
n=20 Participants
In the real boxing (RB) group in addition to the NDT program, real boxing training will be given.
real boxing training: 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.
|
Virtual Boxing Group
n=20 Participants
In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing.
virtual boxing training: 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.
|
|---|---|---|
|
Video Boxing Analysis of Punching
|
37.25 repetitions per minute
Standard Deviation 7.54
|
40.3 repetitions per minute
Standard Deviation 8.58
|
SECONDARY outcome
Timeframe: 8 weeksFullerton 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.
Outcome measures
| Measure |
Real Boxing Group
n=20 Participants
In the real boxing (RB) group in addition to the NDT program, real boxing training will be given.
real boxing training: 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.
|
Virtual Boxing Group
n=20 Participants
In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing.
virtual boxing training: 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.
|
|---|---|---|
|
Fullerton Advanced Balance Scale
|
30.20 score on a scale
Standard Deviation 4.76
|
29.40 score on a scale
Standard Deviation 5.40
|
SECONDARY outcome
Timeframe: 8 weeksAddenbrook'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.
Outcome measures
| Measure |
Real Boxing Group
n=20 Participants
In the real boxing (RB) group in addition to the NDT program, real boxing training will be given.
real boxing training: 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.
|
Virtual Boxing Group
n=20 Participants
In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing.
virtual boxing training: 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.
|
|---|---|---|
|
Addenbrooke's Cognitive Assessment
|
75.55 score on a scale
Standard Deviation 6.39
|
75.05 score on a scale
Standard Deviation 8.47
|
SECONDARY outcome
Timeframe: 8 weeksFrenchay 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.
Outcome measures
| Measure |
Real Boxing Group
n=20 Participants
In the real boxing (RB) group in addition to the NDT program, real boxing training will be given.
real boxing training: 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.
|
Virtual Boxing Group
n=20 Participants
In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing.
virtual boxing training: 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.
|
|---|---|---|
|
Frenchay Activities Index
|
28.40 score on a scale
Standard Deviation 11.53
|
25.20 score on a scale
Standard Deviation 6.14
|
Adverse Events
Real Boxing Group
Virtual Boxing Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Asst. Prof. Dr. Gozde Iyigun
Eastern Mediterranean University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place