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To investigate the effectiveness of neck and trunk stabilization exercises on communication and quality of life (QoL) in children with cerebral palsy (CP) with oral motor problems. Children with CP were randomly divided into Study Group (SG) and Control Group (CG). Neurodevelopmental treatment (NDT) approaches and oral motor therapy were applied to both groups. SG also received neck-trunk stabilization training.
In the multidisciplinary approach, special approaches to secondary problems, oral-motor trainings and communication studies are used in addition to Neurodevelopment treatment approach in the treatment of children with CP. Because of their impact on postural control, neck-trunk stabilization exercises are very important for therapeutic interventions designed to improve quality of life with activities of daily living.
As the increases in neck muscle strength are related to trunk stabilization, trunk stabilization exercises are thought to have positive effects on neck muscle strength. In addition, since the neck and trunk are complementary to each other, it is supported by the literature that neck stabilization exercises and trunk stabilization exercises should be applied together.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group (SG) | Experimental | In addition to feeding and oral motor intervention strategies, intensive neck and trunk stabilization exercises based on Neurodevelopmental treatment-Bobath (NDT-B) concept principles were applied to this group. Treatments were continued 2 days a week for 6 weeks (12 sessions). |
|
| Control Group (CG). | Placebo Comparator | (NDT-B) concept approaches and feeding and oral motor intervention strategies were applied to this group in routine treatment. Treatments were continued 2 days a week for 6 weeks (12 sessions). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurodevelopmental treatment (NDT) | Other | NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) | With VAS, families were asked to mark their communication status with their children. The definitions of the parameter to be evaluated are written on both ends of a 100 mm line. (0= no communication; 10= best communication). According to scale, the higher scores mean a better communication status | Change from VAS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). |
| Katz Index of Independence in Activities of Daily Living (ADL) | Measures the capacity of a child to perform the activities that he/she has to do frequently in his/her daily life. The index has 6 questions. The patient gets 1 point if he/she makes each item independently; 0 points if he/she makes dependent. In the total score, 6 points indicate that patient is independent and 0 points indicate that patient is fully dependent. Higher Katz Index score means the better Activities of Daily Living. | Change from Katz was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). |
| Pediatric Quality of Life Inventory (PedsQL). Version 4.0- Parent Report for Toddlers (Ages 2-4) | It is a quality of life scale that measures health-related quality of life of children. It consists of 21 items. Items are scored between 0-100. The higher total score means a better health-related quality of life. | Change from PedsQL was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). |
| Short Form 36 Questionnaire (SF-36) | Quality of life of mothers was assessed by using the short form 36 questionnaire. It evaluates 8 sub-parameters, consisting of 36 items. 0= poor quality of life; 100= good quality of life. The higher score means a better health-related quality of life | Change from SF-36 was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nasim Ejraei, bachelor | Marmara University | Principal Investigator |
| Aysel Yıldız Ozer, Assoc. Prof. | Marmara University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University Faculty of Health Sciences | Istanbul | Maltepe | 34000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23596639 | Background | Ferluga ED, Archer KR, Sathe NA, Krishnaswami S, Klint A, Lindegren ML, McPheeters ML. Interventions for Feeding and Nutrition in Cerebral Palsy [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Mar. Report No.: 13-EHC015-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK132442/ | |
| 28533628 |
| Label | URL |
|---|---|
| The NDT/Bobath (Neuro-Developmental Treatment/Bobath) Definition. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group (CG). | (NDT-B) concept approaches and feeding and oral-motor intervention strategies were applied to this group in routine treatment. Treatments were continued 2 days a week for 6 weeks (12 sessions). Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology. Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills. |
| FG001 | Study Group (SG) | In addition to feeding and oral-motor intervention strategies, intensive neck and trunk stabilization exercises based on Neurodevelopmental treatment-Bobath (NDT-B) concept principles were applied to this group. Treatments were continued 2 days a week for 6 weeks (12 sessions). Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology. Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills. Neck and trunk stabilization exercises: Trunk control affects head control. After gaining head control, it causes jaw stability and oral motor control (tongue control and lip closure). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group (SG) | In addition to feeding and oral-motor intervention strategies, intensive neck and trunk stabilization exercises based on Neurodevelopmental treatment-Bobath (NDT-B) concept principles were applied to this group. Treatments were continued 2 days a week for 6 weeks (12 sessions). Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology. Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills. Neck and trunk stabilization exercises: Trunk control affects head control. After gaining head control, it causes jaw stability and oral motor control (tongue control and lip closure). |
| 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 | Visual Analogue Scale (VAS) | With VAS, families were asked to mark their communication status with their children. The definitions of the parameter to be evaluated are written on both ends of a 100 mm line. (0= no communication; 10= best communication). According to scale, the higher scores mean a better communication status | Posted | Mean | Standard Deviation | units on a scale | Change from VAS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). |
|
6 weeks.
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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) | In addition to feeding and oral-motor intervention strategies, intensive neck and trunk stabilization exercises based on Neurodevelopmental treatment-Bobath (NDT-B) concept principles were applied to this group. Treatments were continued 2 days a week for 6 weeks (12 sessions). Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology. Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills. Neck and trunk stabilization exercises: Trunk control affects head control. After gaining head control, it causes jaw stability and oral motor control (tongue control and lip closure). |
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The limitations of this study are small sample size and relatively short follow-up time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assoc. Prof Aysel Yıldız Ozer | Marmara University | 5334674433 | +90 | aysel.yildiz@marmara.edu.tr |
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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 | Mar 23, 2018 | Apr 7, 2020 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2018 | Apr 7, 2020 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 3, 2019 | Apr 7, 2020 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D003142 | Communication |
| 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 have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills. |
|
| Neck and trunk stabilization exercises | Other | Trunk control affects head control. After gaining head control, it causes jaw stability and oral motor control (tongue control and lip closure). All of these affect communication and quality of life. |
|
| Viking Speech Scale (VSS) | This scale has been developed to classify children's speech production. The scale has 4 levels. (Level 1= Speech is not affected by motor disorder; 4= No understandable speech). The low scores mean good speech production. | Change from VSS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). |
| Gross Motor Function Classification System (GMFCS) | The gross motor function of children with cerebral palsy can be categorised into 5 different levels for the clear description of a child's current motor function. The higher level in GMFCS, means a worse and severe outcome. (Level I = Children walk without any limits; Level V= Children are limited in their ability to maintain antigravity head and trunk postures and control leg and arm movements). The low levels means good motor function. | Immediately before the intervention, the evaluation was performed in the first session (only one time). |
| Communication Function Classification System (CFCS) | CFCS provides 5 levels (CFCS I, II, III, IV, V) to describe everyday communication performance. The higher level in CFCS means a worse and severe outcome. Level 1= effective sender and receiver with unfamiliar and familiar partners; level 5=seldom effective sender and receiver even with familiar partners. Low levels mean good communication performance | Immediately before the intervention, an evaluation was performed in the first session (only one time). |
| Shin JW, Song GB, Ko J. The effects of neck and trunk stabilization exercises on cerebral palsy children's static and dynamic trunk balance: case series. J Phys Ther Sci. 2017 Apr;29(4):771-774. doi: 10.1589/jpts.29.771. Epub 2017 Apr 20. |
| 24301008 | Background | Arvedson JC. Feeding children with cerebral palsy and swallowing difficulties. Eur J Clin Nutr. 2013 Dec;67 Suppl 2:S9-12. doi: 10.1038/ejcn.2013.224. |
| International Bobath Instructors Training Association | View source |
| BG001 | Control Group (CG). | (NDT-B) concept approaches and feeding and oral-motor intervention strategies were applied to this group in routine treatment. Treatments were continued 2 days a week for 6 weeks (12 sessions). Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology. Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills. |
| 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). | (NDT-B) concept approaches and feeding and oral-motor intervention strategies were applied to this group in routine treatment. Treatments were continued 2 days a week for 6 weeks (12 sessions). Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology. Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills. |
|
|
| Primary | Katz Index of Independence in Activities of Daily Living (ADL) | Measures the capacity of a child to perform the activities that he/she has to do frequently in his/her daily life. The index has 6 questions. The patient gets 1 point if he/she makes each item independently; 0 points if he/she makes dependent. In the total score, 6 points indicate that patient is independent and 0 points indicate that patient is fully dependent. Higher Katz Index score means the better Activities of Daily Living. | Posted | Mean | Standard Deviation | score on a scale | Change from Katz was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). |
|
|
|
| Primary | Pediatric Quality of Life Inventory (PedsQL). Version 4.0- Parent Report for Toddlers (Ages 2-4) | It is a quality of life scale that measures health-related quality of life of children. It consists of 21 items. Items are scored between 0-100. The higher total score means a better health-related quality of life. | 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). |
|
|
|
| Primary | Short Form 36 Questionnaire (SF-36) | Quality of life of mothers was assessed by using the short form 36 questionnaire. It evaluates 8 sub-parameters, consisting of 36 items. 0= poor quality of life; 100= good quality of life. The higher score means a better health-related quality of life | Posted | Mean | Standard Deviation | score on a scale | Change from SF-36 was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). |
|
|
|
| Primary | Viking Speech Scale (VSS) | This scale has been developed to classify children's speech production. The scale has 4 levels. (Level 1= Speech is not affected by motor disorder; 4= No understandable speech). The low scores mean good speech production. | We applied this scale in 13 cases (7 in Study group and 6 in Control group). This scale can only be used for patients with SP in age of 4 and above. Therefore, these 13 cases were between the ages of 4-4.5 and provided sufficient age criteria to apply the scale. | Posted | Mean | Standard Deviation | score on a scale | Change from VSS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session). |
|
|
|
| Primary | Gross Motor Function Classification System (GMFCS) | The gross motor function of children with cerebral palsy can be categorised into 5 different levels for the clear description of a child's current motor function. The higher level in GMFCS, means a worse and severe outcome. (Level I = Children walk without any limits; Level V= Children are limited in their ability to maintain antigravity head and trunk postures and control leg and arm movements). The low levels means good motor function. | Posted | Count of Participants | Participants | Immediately before the intervention, the evaluation was performed in the first session (only one time). |
|
|
|
| Primary | Communication Function Classification System (CFCS) | CFCS provides 5 levels (CFCS I, II, III, IV, V) to describe everyday communication performance. The higher level in CFCS means a worse and severe outcome. Level 1= effective sender and receiver with unfamiliar and familiar partners; level 5=seldom effective sender and receiver even with familiar partners. Low levels mean good communication performance | Posted | Count of Participants | Participants | Immediately before the intervention, an evaluation was performed in the first session (only one time). |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control Group (CG). | (NDT-B) concept approaches and feeding and oral-motor intervention strategies were applied to this group in routine treatment. Treatments were continued 2 days a week for 6 weeks (12 sessions). Neurodevelopmental treatment: NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology. Feeding and oral-motor intervention strategies: Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D001519 | Behavior |
| quadriplegic |
|
| hypotonic |
|
| 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 |
|
| level 5 |
|