Trial Outcomes & Findings for The Effects of Neurodevelopmental Therapy on Feeding and Swallowing. (NCT NCT04403113)
NCT ID: NCT04403113
Last Updated: 2020-12-08
Results Overview
The gross motor functions of children with cerebral palsy were classified with GMFCS. GMFCS is a 5-level classification system. It uses gross motor skills. The aim is to present an idea of how self-sufficient a child can be at home, at school, and outdoor and indoor venues. GMFCS includes levels that reflect abilities ranging from unlimited walking (level I) to severe head and trunk control limitations. Requires extensive use of assisted technology and physical assistance, and wheelchair (level V). The higher level in GMFCS means a worse and severe outcome. The low levels mean good motor function.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Immediately before the intervention, the evaluation was performed in the first session (only one time).
Results posted on
2020-12-08
Participant Flow
Participant milestones
| Measure |
Study Group (SG)
feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding.
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to
|
Control Group (CG).
feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.
|
|---|---|---|
|
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 |
Study Group (SG)
n=20 Participants
feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding.
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to
|
Control Group (CG).
n=20 Participants
feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age range · (18-48 months) <
|
13 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
27 Participants
n=40 Participants
|
|
Age, Customized
Age range · ≥ (48 months)
|
7 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
20 participants
n=20 Participants
|
19 participants
n=20 Participants
|
39 participants
n=40 Participants
|
|
Region of Enrollment
Syria
|
0 participants
n=20 Participants
|
1 participants
n=20 Participants
|
1 participants
n=40 Participants
|
|
Cerebral Palsy type
diplegic
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Cerebral Palsy type
hemiplegic
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Cerebral Palsy type
quadriplegic
|
8 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Cerebral Palsy type
hypotonic
|
6 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Cerebral Palsy type
dyskinetic
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Immediately before the intervention, the evaluation was performed in the first session (only one time).The gross motor functions of children with cerebral palsy were classified with GMFCS. GMFCS is a 5-level classification system. It uses gross motor skills. The aim is to present an idea of how self-sufficient a child can be at home, at school, and outdoor and indoor venues. GMFCS includes levels that reflect abilities ranging from unlimited walking (level I) to severe head and trunk control limitations. Requires extensive use of assisted technology and physical assistance, and wheelchair (level V). The higher level in GMFCS means a worse and severe outcome. The low levels mean good motor function.
Outcome measures
| Measure |
Study Group (SG)
n=20 Participants
feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding.
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding.
|
Control Group (CG).
n=20 Participants
feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.
|
|---|---|---|
|
Gross Motor Function Classification System (GMFCS)
level 1
|
4 Participants
|
2 Participants
|
|
Gross Motor Function Classification System (GMFCS)
level 2
|
0 Participants
|
0 Participants
|
|
Gross Motor Function Classification System (GMFCS)
level 3
|
2 Participants
|
0 Participants
|
|
Gross Motor Function Classification System (GMFCS)
level 4
|
4 Participants
|
4 Participants
|
|
Gross Motor Function Classification System (GMFCS)
level 5
|
10 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Immediately before the intervention, the evaluation was performed in the first session (only one time).EDACS describes the eating and drinking skills of children with cerebral palsy from the age of 3. It is an ordered scale that defines the degree of assistance required during the meal and the individual's ability to eat and drink between five levels. Level I, safely and efficiently eating and drinking; at level V, it indicates unable to eat or drink safely, relies on tube feeding and is at high risk for aspiration.
Outcome measures
| Measure |
Study Group (SG)
n=16 Participants
feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding.
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding.
|
Control Group (CG).
n=11 Participants
feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.
|
|---|---|---|
|
the Eating and Drinking Ability Classification System (EDACS)
level 1
|
1 Participants
|
0 Participants
|
|
the Eating and Drinking Ability Classification System (EDACS)
level 2
|
3 Participants
|
1 Participants
|
|
the Eating and Drinking Ability Classification System (EDACS)
level 3
|
5 Participants
|
7 Participants
|
|
the Eating and Drinking Ability Classification System (EDACS)
level 4
|
5 Participants
|
2 Participants
|
|
the Eating and Drinking Ability Classification System (EDACS)
level 5
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Immediately before the intervention, the evaluation was performed in the first session (only one time).Mini-MACS is a functional classification that defines how children with cerebral palsy between the ages of 1 and 4 use their hands while holding objects in daily activities. Skill classes at five levels, based on the need for self-help and adaptation when children hold objects. Level I. Handles objects easily and successfully. Level V. Does not handle objects and has severely limited ability to perform even simple actions.
Outcome measures
| Measure |
Study Group (SG)
n=20 Participants
feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding.
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding.
|
Control Group (CG).
n=20 Participants
feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.
|
|---|---|---|
|
the Mini-Manual Ability Classification System (Mini-MACS)
level 3
|
5 Participants
|
5 Participants
|
|
the Mini-Manual Ability Classification System (Mini-MACS)
level 4
|
3 Participants
|
2 Participants
|
|
the Mini-Manual Ability Classification System (Mini-MACS)
level 5
|
7 Participants
|
9 Participants
|
|
the Mini-Manual Ability Classification System (Mini-MACS)
level 1
|
1 Participants
|
1 Participants
|
|
the Mini-Manual Ability Classification System (Mini-MACS)
level 2
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Change from TIS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).TIS is a validated scale for cerebral palsy that evaluates the trunk functionally in terms of strength in a sitting position. It also complies with the International Classification of Functionality, Disability and Health in terms of evaluating the static and dynamic balance and trunk coordination of the trunk and the relationship between body function and structures. TIS consists of three subscales: static, dynamic and coordination. For each item; sequential scales with 2, 3 or 4 values are used. The highest scores that can be obtained from the static, dynamic and coordination subscales are; it is 7, 10 and 6 points. Total points are obtained by adding all subscales. The total TIS score ranges from 0 to 23. A high score indicates good trunk control.
Outcome measures
| Measure |
Study Group (SG)
n=20 Participants
feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding.
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding.
|
Control Group (CG).
n=20 Participants
feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.
|
|---|---|---|
|
Trunk Impairment Scale (TIS)
|
5.65 score on a scale
Standard Deviation 6.11
|
2.90 score on a scale
Standard Deviation 5.28
|
PRIMARY outcome
Timeframe: Change from SOMA was assessed in 0 week (Baseline, in the first session, Before treatment), 6. week (6 weeks after treatment, in the 12th session, After treatment).SOMA is a measure which identifies "oral-motor dysfunction" (OMD). SOMA involves videotaping children and later assessing their feeding skills. Test was implemented in the presence of the child's main caregiver. The entire assessment lasted 20-30 minutes. SOMA has 7 subcategories. Each subcategory has its own cut-off point. Among the "yes" or "no" options opposite the observed parameters, the appropriate one is marked. In some options, the "yes" option indicates an abnormal function, while in some options the "no" option indicates the presence of an abnormal function. BOTTLE, TRAINER CUP, CUP(Cutting Score): ≥ 5 indicates OMD. \< 5 indicates normal oral-motor function(OMF). PUREE: ≥ 3 indicates OMD. \< 3 indicates normal OMF. SEMI-SOLIDS, SOLIDS: ≥ 4 indicates OMD. \< 4 indicates normal OMF. CRACKER: ≥ 9 indicates OMD. \< 9 indicates normal OMF. BOTTLE, CUP, PUREE, SOLIDS; minimum(mi) score: 0, maximum(ma): 9. TRAINER CUP; mi: 0, ma: 14. SEMI-SOLIDS; mi: 0, ma: 8. CRACKER; mi: 0, ma: 22.
Outcome measures
| Measure |
Study Group (SG)
n=20 Participants
feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding.
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding.
|
Control Group (CG).
n=20 Participants
feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.
|
|---|---|---|
|
Schedule for Oral Motor Assessment (SOMA)
Semi solids (Before treatment)
|
2.15 score on a scale
Standard Deviation 1.30
|
2.05 score on a scale
Standard Deviation 1.39
|
|
Schedule for Oral Motor Assessment (SOMA)
Trainer cup (Before treatment)
|
2.10 score on a scale
Standard Deviation 1.44
|
3.70 score on a scale
Standard Deviation 0.92
|
|
Schedule for Oral Motor Assessment (SOMA)
Trainer cup (After treatment)
|
3.75 score on a scale
Standard Deviation 1.01
|
3.10 score on a scale
Standard Deviation 1.51
|
|
Schedule for Oral Motor Assessment (SOMA)
Puree (Before treatment)
|
2.05 score on a scale
Standard Deviation 0.99
|
2.10 score on a scale
Standard Deviation 1.16
|
|
Schedule for Oral Motor Assessment (SOMA)
Puree (After treatment)
|
1.75 score on a scale
Standard Deviation 1.20
|
1.55 score on a scale
Standard Deviation 1.23
|
|
Schedule for Oral Motor Assessment (SOMA)
Bottle (Before treatment)
|
3.55 score on a scale
Standard Deviation 1.14
|
2.75 score on a scale
Standard Deviation 1.58
|
|
Schedule for Oral Motor Assessment (SOMA)
Bottle (After treatment)
|
2.35 score on a scale
Standard Deviation 1.63
|
2.70 score on a scale
Standard Deviation 1.62
|
|
Schedule for Oral Motor Assessment (SOMA)
Cup (Before treatment)
|
2.60 score on a scale
Standard Deviation 1.53
|
2.50 score on a scale
Standard Deviation 1.57
|
|
Schedule for Oral Motor Assessment (SOMA)
Cup (After treatment)
|
2.10 score on a scale
Standard Deviation 1.41
|
1.95 score on a scale
Standard Deviation 1.53
|
|
Schedule for Oral Motor Assessment (SOMA)
Semi solids (After treatment)
|
1.95 score on a scale
Standard Deviation 1.39
|
1.90 score on a scale
Standard Deviation 1.37
|
|
Schedule for Oral Motor Assessment (SOMA)
Solids (Before treatment)
|
2.70 score on a scale
Standard Deviation 1.12
|
2.35 score on a scale
Standard Deviation 1.42
|
|
Schedule for Oral Motor Assessment (SOMA)
Solids (After treatment)
|
2.35 score on a scale
Standard Deviation 1.38
|
2.35 score on a scale
Standard Deviation 1.38
|
|
Schedule for Oral Motor Assessment (SOMA)
Cracker (Before treatment)
|
2.45 score on a scale
Standard Deviation 1.31
|
2.25 score on a scale
Standard Deviation 1.51
|
|
Schedule for Oral Motor Assessment (SOMA)
Cracker (After treatment)
|
2.30 score on a scale
Standard Deviation 1.38
|
2.10 score on a scale
Standard Deviation 1.37
|
PRIMARY outcome
Timeframe: Change from PedsQL was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).The Quality of Life Scale for Children is a general quality of life scale which assesses the physical and psychosocial experiences independent of disease in children between the ages of 2 and 18 years. The scale is composed of 23 items. The items are scored between 0 and 100. The higher the score for the Quality of Life Scale for children, the better is the perception of health-related quality of life. In our study, the total score of the scale was used.
Outcome measures
| Measure |
Study Group (SG)
n=20 Participants
feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding.
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding.
|
Control Group (CG).
n=20 Participants
feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.
|
|---|---|---|
|
Pediatric Quality of Life Inventory (PedsQL)
|
48.42 score on a scale
Standard Deviation 18.33
|
53.48 score on a scale
Standard Deviation 20.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: It was applied after the evaluation in the first session.Instrumental evaluation of swallowing is a technique that allows the evaluation of swallowing physiology and anatomy in patients. The most commonly used form in the clinic is Flexible Fiberoptic Endoscopic Methods. The structures and functions related to swallowing are evaluated using through a fiberoptic tube extending from the nose to the pharynx. FEES allows direct visualization of some aspects of the pharyngeal phase. It gives information about the physiological changes that occur before and after swallowing. Since velopharyngeal closure occurs during swallowing, observation cannot be made. The pharynx, tongue root vallecula, pyriform sinuses, and residues formed after swallowing in the airway can be traced. There is no uniform decision to decide if a child should switch from oral feeding to enteral tube feeding, but there is a general consensus.
Outcome measures
| Measure |
Study Group (SG)
n=4 Participants
feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding.
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding.
|
Control Group (CG).
n=4 Participants
feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.
|
|---|---|---|
|
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Normal swallowing and oral diet
|
4 Participants
|
3 Participants
|
|
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Dysphagia and non-oral diet
|
0 Participants
|
1 Participants
|
Adverse Events
Study Group (SG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group (CG).
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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