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Our study is planned to investigate the effects of neck and trunk stabilization exercises, which are structured from Neurodevelopmental therapy method-Bobath concept (NDT-B) principles, on feeding and swallowing activity in children with Cerebral Palsy (CP) who take feeding and oral motor intervention strategies. The cases were divided into two groups, which is the group receiving feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises (n=20) (Study Group) and those receiving feeding and oral motor intervention strategies (n=20) (Control Group).
Feeding and oral motor interventions address different aspects of feeding difficulties, reflecting the range in specific problems associated with feeding and nutrition in CP.
The trunk plays an important role in the organization of postural control and balance reactions because it holds the centre of all body mass and holds therefore, the centre of gravity. The trunk also provides stable attachment points to those muscles that control the head and neck regions. "Neck and trunk stabilization exercises" were the basis of static and dynamic balance abilities, and that increased neck and trunk stability might have had a positive effect thereon.
To achieve the alignment of the head with the trunk, the pelvis must be stabilized. This has important consequences for the entire process of swallowing. If the head is not stable, then the fine movements of the jaw and tongue needed for feeding will be impaired. With feeding and oral motor interventions and structured neck and trunk stabilization exercises, these parameters are positively affected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group (SG) | Experimental | feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding (Study Group) |
|
| Control Group (CG). | Placebo Comparator | feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured neck and trunk stabilization exercises | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gross Motor Function Classification System (GMFCS) | 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. | Immediately before the intervention, the evaluation was performed in the first session (only one time). |
| the Eating and Drinking Ability Classification System (EDACS) | 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. | Immediately before the intervention, the evaluation was performed in the first session (only one time). |
| the Mini-Manual Ability Classification System (Mini-MACS) | 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. | Immediately before the intervention, the evaluation was performed in the first session (only one time). |
| Trunk Impairment Scale (TIS) | 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Fiberoptic Endoscopic Evaluation of Swallowing (FEES) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nasim EJRAEI, Master D | Marmara University | Principal Investigator |
| Gonul Acar, Assoc. Prof | Marmara University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University Pendik Training and Research Hospital | Istanbul | Pendik | 0216 625 45 45/34899 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34173063 | Derived | Acar G, Ejraei N, Turkdogan D, Enver N, Ozturk G, Aktas G. The Effects of Neurodevelopmental Therapy on Feeding and Swallowing Activities in Children with Cerebral Palsy. Dysphagia. 2022 Aug;37(4):800-811. doi: 10.1007/s00455-021-10329-w. Epub 2021 Jun 25. |
| Label | URL |
|---|---|
| Feeding children with cerebral palsy and swallowing difficulties | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gross Motor Function Classification System (GMFCS) | 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. | Posted | Count of Participants | Participants | Immediately before the intervention, the evaluation was performed in the first session (only one time). |
|
6 weeks for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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In the study, it can be stated as the limitation of the study that all children with feeing problems are screened for only 40 cases and heterogeneous types are included in the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assoc. Prof Gonul Acar | Marmara University | 5323778878 | +90 | gonulacar34@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 15, 2018 | May 28, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2019 | May 28, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 27, 2018 | May 28, 2020 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Feeding and oral motor intervention strategies | Other | 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 | Other | 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. |
|
| Change from TIS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). |
| Schedule for Oral Motor Assessment (SOMA) | 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. | 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). |
| Pediatric Quality of Life Inventory (PedsQL) | 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. | Change from PedsQL was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). |
| It was applied after the evaluation in the first session. |
| The importance of postural control for feeding. | View source |
| The effects of neck and trunk stabilization exercises on cerebral palsy children's static and dynamic trunk balance: case series | View source |
| The objective rating of oral-motor functions during feeding | View source |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cerebral Palsy type | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Primary | the Eating and Drinking Ability Classification System (EDACS) | 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. | Posted | Count of Participants | Participants | Immediately before the intervention, the evaluation was performed in the first session (only one time). |
|
|
|
| Primary | the Mini-Manual Ability Classification System (Mini-MACS) | 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. | Posted | Count of Participants | Participants | Immediately before the intervention, the evaluation was performed in the first session (only one time). |
|
|
|
| Primary | Trunk Impairment Scale (TIS) | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from TIS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). |
|
|
|
| Primary | Schedule for Oral Motor Assessment (SOMA) | 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. | Posted | Mean | Standard Deviation | score on a scale | 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). |
|
|
|
| Primary | Pediatric Quality of Life Inventory (PedsQL) | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from PedsQL was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). |
|
|
|
| Other Pre-specified | Fiberoptic Endoscopic Evaluation of Swallowing (FEES) | 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. | Posted | Count of Participants | Participants | No | It was applied after the evaluation in the first session. |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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| quadriplegic |
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| hypotonic |
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| dyskinetic |
|
| level 3 |
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| level 4 |
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| level 5 |
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| level 3 |
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| level 4 |
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| level 5 |
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| Puree (Before treatment) |
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| Puree (After treatment) |
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| Bottle (Before treatment) |
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| Bottle (After treatment) |
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| Cup (Before treatment) |
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| Cup (After treatment) |
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| Semi solids (Before treatment) |
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| Semi solids (After treatment) |
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| Solids (Before treatment) |
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| Solids (After treatment) |
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| Cracker (Before treatment) |
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| Cracker (After treatment) |
|