Trial Outcomes & Findings for Expiratory Muscle Training in Stroke (NCT NCT04569968)
NCT ID: NCT04569968
Last Updated: 2023-03-31
Results Overview
To assess masticatory performance of the patients, patients will be asked to chew 3 gr of peanuts with 20 chewing stroke and then spit on a sieve with 10 mesh and 1700 µm width. Then the residue will be collected and put into the centrifuge tube. After that residue will be centrifuged for 3 minutes with 1500 rpm. Same procedure will be used for the sieved content. Then this two values will be divided and recorded as a percentage for the calculation masticatory performance index.
COMPLETED
NA
146 participants
Two measurements: At the beginning and after three weeks
2023-03-31
Participant Flow
Patients recruited from İzzet Baysal Physical Therapy Education and Research Hospital between 18.08.2020 and 06.09.2021.
Patients who had the following situations were excluded from the study; stroke onset of time higher than 3 months, hemorrhagic stroke, cooperation problem, age of 64 or younger, denial of participation to the study, head and/or neck surgery existence, discharge, free of temporomandibular joint dysfunction, existence of infection, incisor and/or canin tooth absence, quarantine, insufficient mastication.
Participant milestones
| Measure |
Expiratory Muscle Training Group
Daily expiratory muscle training for three weeks with 50 repetition was applied to the experimental group.
|
Control Group
Nothing applied except for the hospital conventional physiotherapy program.
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
60
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
71
|
44
|
Reasons for withdrawal
| Measure |
Expiratory Muscle Training Group
Daily expiratory muscle training for three weeks with 50 repetition was applied to the experimental group.
|
Control Group
Nothing applied except for the hospital conventional physiotherapy program.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
|
Overall Study
Story of head and/or neck surgery
|
2
|
2
|
|
Overall Study
Time of stroke onset
|
8
|
7
|
|
Overall Study
Type of strokr
|
12
|
8
|
|
Overall Study
Cooperation
|
8
|
8
|
|
Overall Study
Age interval
|
17
|
6
|
|
Overall Study
Denial of participation to the study
|
0
|
3
|
|
Overall Study
Free of temporomandibular joint dysfunction
|
4
|
2
|
|
Overall Study
Lack of incisor and/or canin tooth
|
5
|
3
|
|
Overall Study
Quarantine
|
1
|
0
|
|
Overall Study
Previous recruitment to the expiratory muscle training
|
2
|
0
|
|
Overall Study
Repetitive stroke
|
8
|
0
|
|
Overall Study
Insufficient mastication
|
1
|
0
|
|
Overall Study
Infection
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Expiratory Muscle Training Group
n=15 Participants
Daily expiratory muscle training for three weeks with 50 repetition was applied to the experimental group.
|
Control Group
n=16 Participants
Nothing applied except for the hospital conventional physiotherapy program.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=15 Participants
|
7 Participants
n=16 Participants
|
17 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=15 Participants
|
9 Participants
n=16 Participants
|
14 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=15 Participants
|
9 Participants
n=16 Participants
|
13 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=15 Participants
|
7 Participants
n=16 Participants
|
18 Participants
n=31 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Two measurements: At the beginning and after three weeksTo assess masticatory performance of the patients, patients will be asked to chew 3 gr of peanuts with 20 chewing stroke and then spit on a sieve with 10 mesh and 1700 µm width. Then the residue will be collected and put into the centrifuge tube. After that residue will be centrifuged for 3 minutes with 1500 rpm. Same procedure will be used for the sieved content. Then this two values will be divided and recorded as a percentage for the calculation masticatory performance index.
Outcome measures
| Measure |
Expiratory Muscle Training Group
n=15 Participants
Daily expiratory muscle training for three weeks will be applied.
Expiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.
|
Control Group
n=16 Participants
Nothing will be applied except for the hospital conventional physiotherapy program.
|
|---|---|---|
|
Change in Masticatory Performance
First measurement
|
24 percentage of masticated peanuts
Standard Deviation 18
|
13 percentage of masticated peanuts
Standard Deviation 7
|
|
Change in Masticatory Performance
Last measurement
|
25 percentage of masticated peanuts
Standard Deviation 17
|
16 percentage of masticated peanuts
Standard Deviation 10
|
PRIMARY outcome
Timeframe: Two measurements: At the beginning and after three weeksMandibular depression, protrusion and bilateral lateral deviation of the patients will be performed by a digital caliper. All measurements will be taken while the patients are seated with their head supported. Digital caliper will be positioned in central incisors for the mandibular depression and the protrusion. For lateral deviation first upper central incisor location in relation to the lower central incisor will be drawn by a biocompatible pen then measurement will be performed. After that, a second drawing made. Then the horizontal distance between these two points will be measured for the lateral deviation range of motion. Reference values for mandibular depression, protrusion and the lateral deviation are as follows: 40 mm, 6 mm, and 8 mm.
Outcome measures
| Measure |
Expiratory Muscle Training Group
n=15 Participants
Daily expiratory muscle training for three weeks will be applied.
Expiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.
|
Control Group
n=16 Participants
Nothing will be applied except for the hospital conventional physiotherapy program.
|
|---|---|---|
|
Change in Temporomandibular Range of Motion Measurement
Mandibular depression last measurement
|
41.90 milimeter
Standard Deviation 6.71
|
41.09 milimeter
Standard Deviation 7.10
|
|
Change in Temporomandibular Range of Motion Measurement
Left lateral deviation first measurement
|
7.61 milimeter
Standard Deviation 2.97
|
5.25 milimeter
Standard Deviation 2.33
|
|
Change in Temporomandibular Range of Motion Measurement
Mandibular depression first measurement
|
39.55 milimeter
Standard Deviation 6.42
|
41.48 milimeter
Standard Deviation 7.40
|
|
Change in Temporomandibular Range of Motion Measurement
Left lateral deviation last measurement
|
6.84 milimeter
Standard Deviation 1.92
|
5.49 milimeter
Standard Deviation 1.98
|
|
Change in Temporomandibular Range of Motion Measurement
Right lateral deviation first measurement
|
7.44 milimeter
Standard Deviation 2.04
|
5.54 milimeter
Standard Deviation 2.49
|
|
Change in Temporomandibular Range of Motion Measurement
Right lateral deviation last measurement
|
8.09 milimeter
Standard Deviation 2.34
|
5.61 milimeter
Standard Deviation 2.15
|
|
Change in Temporomandibular Range of Motion Measurement
Protrusion first measurement
|
5.28 milimeter
Standard Deviation 1.61
|
4.17 milimeter
Standard Deviation 1.83
|
|
Change in Temporomandibular Range of Motion Measurement
Protrusion last measurement
|
5.56 milimeter
Standard Deviation 1.18
|
4.62 milimeter
Standard Deviation 2.21
|
PRIMARY outcome
Timeframe: Two measurements: At the beginning and after three weeksOral health of the patients will be assessed with general oral health assessment index. Index consists of twelve questions. Answers of these twelve questions makes up the total score. Minimum and maximum scores of the index are 12 and 60 points. Higher total scores mean higher risk of losing the general oral health.
Outcome measures
| Measure |
Expiratory Muscle Training Group
n=15 Participants
Daily expiratory muscle training for three weeks will be applied.
Expiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.
|
Control Group
n=16 Participants
Nothing will be applied except for the hospital conventional physiotherapy program.
|
|---|---|---|
|
Change in General Oral Health Assessment Index
First assessment
|
52 Score on index
Interval 46.0 to 52.0
|
52 Score on index
Interval 34.0 to 53.0
|
|
Change in General Oral Health Assessment Index
Last assessment
|
52 Score on index
Interval 46.0 to 52.0
|
52 Score on index
Interval 34.0 to 53.0
|
PRIMARY outcome
Timeframe: Two measurements: At the beginning and after three weeksSwallowing quality of the patients will be assessed with eating assessment tool (EAT-10). the tool has ten questions and the total score of the tool is 40 points. Minimum score is 0 point and the maximum score is 40 point. Higher total scores mean higher risk of losing the general oral health.
Outcome measures
| Measure |
Expiratory Muscle Training Group
n=15 Participants
Daily expiratory muscle training for three weeks will be applied.
Expiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.
|
Control Group
n=16 Participants
Nothing will be applied except for the hospital conventional physiotherapy program.
|
|---|---|---|
|
Change in Eating Assessment Tool (EAT-10)
First assessment
|
0 score on a scale
Interval 0.0 to 6.0
|
0 score on a scale
Interval 0.0 to 5.0
|
|
Change in Eating Assessment Tool (EAT-10)
Last assessment
|
0 score on a scale
Interval 0.0 to 4.0
|
0 score on a scale
Interval 0.0 to 5.0
|
PRIMARY outcome
Timeframe: Two measurements: At the beginning and after three weeksTwo points in the masseter muscle and two points at the temporalis muscle, in total four points will be measured for the pain pressure threshold assessment. Measurements will be taken four times from every point with two-minute intervals. Due to first measurement values are generally high, average of the last three measurements will be calculated and recorded.
Outcome measures
| Measure |
Expiratory Muscle Training Group
n=15 Participants
Daily expiratory muscle training for three weeks will be applied.
Expiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.
|
Control Group
n=16 Participants
Nothing will be applied except for the hospital conventional physiotherapy program.
|
|---|---|---|
|
Change in Pain Pressure Threshold of the Masticatory Muscles
Right anterior temporalis first measurement
|
2.3 kilogram
Interval 1.9 to 3.06
|
1.86 kilogram
Interval 1.56 to 2.56
|
|
Change in Pain Pressure Threshold of the Masticatory Muscles
Right anterior temporalis last measurement
|
2.3 kilogram
Interval 2.0 to 2.76
|
1.86 kilogram
Interval 1.66 to 2.6
|
|
Change in Pain Pressure Threshold of the Masticatory Muscles
Left anterior temporalis first measurement
|
2.3 kilogram
Interval 1.9 to 2.96
|
1.83 kilogram
Interval 1.6 to 2.5
|
|
Change in Pain Pressure Threshold of the Masticatory Muscles
Left anterior temporalis last measurement
|
2.33 kilogram
Interval 2.0 to 2.66
|
1.8 kilogram
Interval 1.7 to 2.63
|
|
Change in Pain Pressure Threshold of the Masticatory Muscles
Right middle temporalis first measurement
|
2.3 kilogram
Interval 2.0 to 3.16
|
1.91 kilogram
Interval 1.7 to 2.73
|
|
Change in Pain Pressure Threshold of the Masticatory Muscles
Right middle temporalis last measurement
|
2.5 kilogram
Interval 2.0 to 2.86
|
1.95 kilogram
Interval 1.76 to 2.7
|
|
Change in Pain Pressure Threshold of the Masticatory Muscles
Left middle temporalis first measurement
|
2.3 kilogram
Interval 2.0 to 3.13
|
1.9 kilogram
Interval 1.7 to 2.7
|
|
Change in Pain Pressure Threshold of the Masticatory Muscles
Left middle temporalis last measurement
|
2.43 kilogram
Interval 2.0 to 2.83
|
1.9 kilogram
Interval 1.8 to 2.73
|
|
Change in Pain Pressure Threshold of the Masticatory Muscles
Right anterior masseter first measurement
|
1.5 kilogram
Interval 1.36 to 1.86
|
1.3 kilogram
Interval 1.1 to 1.76
|
|
Change in Pain Pressure Threshold of the Masticatory Muscles
Right anterior masseter last measurement
|
1.5 kilogram
Interval 1.2 to 1.66
|
1.3 kilogram
Interval 1.2 to 1.83
|
|
Change in Pain Pressure Threshold of the Masticatory Muscles
Left anterior masseter first measurement
|
1.5 kilogram
Interval 1.13 to 1.83
|
1.3 kilogram
Interval 1.1 to 1.8
|
|
Change in Pain Pressure Threshold of the Masticatory Muscles
Left anterior masseter last measurement
|
1.5 kilogram
Interval 1.1 to 1.66
|
1.31 kilogram
Interval 1.2 to 1.8
|
|
Change in Pain Pressure Threshold of the Masticatory Muscles
Right inferior masseter first measurement
|
1.4 kilogram
Interval 1.3 to 1.8
|
1.24 kilogram
Interval 1.1 to 1.66
|
|
Change in Pain Pressure Threshold of the Masticatory Muscles
Right inferior masseter last measurement
|
1.46 kilogram
Interval 1.1 to 1.73
|
1.3 kilogram
Interval 1.2 to 1.73
|
|
Change in Pain Pressure Threshold of the Masticatory Muscles
Left inferior masseter first measurement
|
1.5 kilogram
Interval 1.13 to 1.7
|
1.2 kilogram
Interval 1.1 to 1.7
|
|
Change in Pain Pressure Threshold of the Masticatory Muscles
Left inferior masseter last measurement
|
1.46 kilogram
Interval 1.1 to 1.6
|
1.3 kilogram
Interval 1.1 to 2.1
|
PRIMARY outcome
Timeframe: Two measurements: At the beginning and after three weeksMeasurement will be taken while the patients are seated and their head in natural position. After that photos of the patients will be taken and then processus spinosus of the C7 and the tragus of the ear will be marked. After that, the angle between those to marking will be measured by the protractor.
Outcome measures
| Measure |
Expiratory Muscle Training Group
n=15 Participants
Daily expiratory muscle training for three weeks will be applied.
Expiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.
|
Control Group
n=16 Participants
Nothing will be applied except for the hospital conventional physiotherapy program.
|
|---|---|---|
|
Change in Craniocervical Angle Measurement
First measurement
|
28.93 degree
Standard Deviation 12.54
|
29.09 degree
Standard Deviation 11.95
|
|
Change in Craniocervical Angle Measurement
Last measurement
|
27.07 degree
Standard Deviation 12.57
|
30.53 degree
Standard Deviation 11.95
|
PRIMARY outcome
Timeframe: Two measurements: At the beginning and after three weeksPatients will be asked to swallow their saliva as much as they can do in thirty seconds.
Outcome measures
| Measure |
Expiratory Muscle Training Group
n=15 Participants
Daily expiratory muscle training for three weeks will be applied.
Expiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.
|
Control Group
n=16 Participants
Nothing will be applied except for the hospital conventional physiotherapy program.
|
|---|---|---|
|
Change in Repeated Saliva Swallow Test
First assessment
|
3 mililiter
Interval 2.0 to 6.0
|
2.5 mililiter
Interval 2.0 to 4.0
|
|
Change in Repeated Saliva Swallow Test
Last assessment
|
3 mililiter
Interval 2.0 to 6.0
|
3 mililiter
Interval 2.0 to 4.0
|
PRIMARY outcome
Timeframe: Two measurements: At the beginning and after three weeksTemporomandibular joint dysfunction existence and its severity will be assessed with Fonseca Questionnaire. Questionnaire includes 10 questions with yes, sometimes and no answers matching with 10, 5, and 0 point. Total score of the questionnaire is 100 point. Categorization of dysfunction by the questionnaire as follows; 70-100 point: severe dysfunction, 45-65: moderate dysfunction, 20-40: mild dysfunction and 0-15: has no dysfunction at all.
Outcome measures
| Measure |
Expiratory Muscle Training Group
n=15 Participants
Daily expiratory muscle training for three weeks will be applied.
Expiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.
|
Control Group
n=16 Participants
Nothing will be applied except for the hospital conventional physiotherapy program.
|
|---|---|---|
|
Change in Fonseca Questionnaire
First value
|
25 score on a scale
Interval 20.0 to 40.0
|
20 score on a scale
Interval 20.0 to 40.0
|
|
Change in Fonseca Questionnaire
Last value
|
25 score on a scale
Interval 10.0 to 40.0
|
20 score on a scale
Interval 15.0 to 30.0
|
PRIMARY outcome
Timeframe: Two measurements: At the beginning and after three weeksSaliva of the patients will be collected between 08:00-12:00 am. After the saliva collected in centrifuge tube reaches 5 ml, collection process will be stopped and immediately pH of the saliva measured with two decimal digital pH meter
Outcome measures
| Measure |
Expiratory Muscle Training Group
n=15 Participants
Daily expiratory muscle training for three weeks will be applied.
Expiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.
|
Control Group
n=16 Participants
Nothing will be applied except for the hospital conventional physiotherapy program.
|
|---|---|---|
|
Change in Intraoral pH Measurement
First measurement
|
6.45 pH
Standard Deviation 0.28
|
6.66 pH
Standard Deviation 0.4
|
|
Change in Intraoral pH Measurement
Last measurement
|
6.54 pH
Standard Deviation 0.3
|
6.63 pH
Standard Deviation 0.34
|
PRIMARY outcome
Timeframe: Two measurements: At the beginning and after three weeksTest will be performed while the patients are in supine position. After the position is taken patient will be asked to elevate their head about one inch and keep it that way as much as they can do. The period that passes from starting to the positional alteration will be recorded as the test score.
Outcome measures
| Measure |
Expiratory Muscle Training Group
n=15 Participants
Daily expiratory muscle training for three weeks will be applied.
Expiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.
|
Control Group
n=16 Participants
Nothing will be applied except for the hospital conventional physiotherapy program.
|
|---|---|---|
|
Change in Neck Flexor Endurance Test
First assessment
|
24.02 second
Standard Deviation 10.89
|
27.12 second
Standard Deviation 11.58
|
|
Change in Neck Flexor Endurance Test
Last assessment
|
26.97 second
Standard Deviation 14.25
|
27.92 second
Standard Deviation 10.58
|
SECONDARY outcome
Timeframe: At the enrollment processMini mental state exam test that consist of eleven articles will be used to assess whether the patients' mental state meets for the study enrollment. Total score is maximum 30 point. Lower score characterized with cognitive dysfunction. Cut off point of the test is 24 point or higher which means no cognitive impairment. 18 to 23 point means mild cognitive dysfunction. Total score below the 18 point means severe cognitive dusfunction. Minimum score is zero maximum score is 30.
Outcome measures
| Measure |
Expiratory Muscle Training Group
n=15 Participants
Daily expiratory muscle training for three weeks will be applied.
Expiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.
|
Control Group
n=16 Participants
Nothing will be applied except for the hospital conventional physiotherapy program.
|
|---|---|---|
|
Mini Mental State Exame Test
|
26.13 score on a scale
Standard Deviation 1.73
|
25.06 score on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Two measurements: At the beginning and after three weeksFacial asymmetry of the patients will be assessed with labial commissure angle measurements. Black and white photos of the patients will be taken while the patients are in a seating position. Then photo will be printed in A5 sheet. After that, the angle between bilateral labial commissures, glabella, and the mental protuberance will be measured. Reference value of the labial commissure angle is approximately 90 degrees.
Outcome measures
| Measure |
Expiratory Muscle Training Group
n=15 Participants
Daily expiratory muscle training for three weeks will be applied.
Expiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.
|
Control Group
n=16 Participants
Nothing will be applied except for the hospital conventional physiotherapy program.
|
|---|---|---|
|
Change in Labial Commissure Angle
First measurement
|
91 degree
Interval 83.5 to 93.0
|
92 degree
Interval 89.0 to 98.0
|
|
Change in Labial Commissure Angle
Last measurement
|
90 degree
Interval 85.0 to 92.0
|
90.5 degree
Interval 89.0 to 95.0
|
Adverse Events
Expiratory Muscle Training Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place