An interventional study of Neurodevelopmental treatment (NDT) and Feeding and oral-motor intervention strategies in Cerebral Palsy, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 18 Months to 54 Months. Per ClinicalTrials.gov, last updated 2020-05-05.
Sponsored by Marmara University · Not applicable, Interventional, and Treatment
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.
1,852 studies on the registry are indexed under Cerebral Palsy; 437 are open to participants now.
This study's enrollment of 40 is above the median of 34 across 1,368 interventional studies indexed under Cerebral Palsy.
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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).
Other: Neurodevelopmental treatment (NDT) · Other: Feeding and oral-motor intervention strategies · Other: Neck and trunk stabilization exercises
(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).
Other: Neurodevelopmental treatment (NDT) · Other: Feeding and oral-motor intervention strategies
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 have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills.
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.
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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Change from SF-36 was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
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.
Time frame: 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.
Time frame: 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
Time frame: Immediately before the intervention, an evaluation was performed in the first session (only one time).
| Milestone | Control Group (CG). | Study Group (SG) |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
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
| units on a scale | Study Group (SG) | Control Group (CG). |
|---|---|---|
| Visual Analogue Scale (VAS) | 6.75 ± 3.10 | 5.29 ± 3.33 |
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.
| score on a scale | Study Group (SG) | Control Group (CG). |
|---|---|---|
| Katz Index of Independence in Activities of Daily Living (ADL) | 0.70 ± 1.26 | 0.55 ± 1.39 |
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.
| score on a scale | Study Group (SG) | Control Group (CG). |
|---|---|---|
| Pediatric Quality of Life Inventory (PedsQL). Version 4.0- Parent Report for Toddlers (Ages 2-4) | 48.42 ± 18.33 | 53.48 ± 20.28 |
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
| score on a scale | Study Group (SG) | Control Group (CG). |
|---|---|---|
| Short Form 36 Questionnaire (SF-36) | 80.25 ± 26.97 | 81.75 ± 17.93 |
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.
| score on a scale | Study Group (SG) | Control Group (CG). |
|---|---|---|
| Viking Speech Scale (VSS) | 3.14 ± 1.06 | 3.50 ± 0.837 |
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.
| Participants | Study Group (SG) | Control Group (CG). |
|---|---|---|
| level 1 | 4 | 2 |
| level 2 | 0 | 0 |
| level 3 | 2 | 0 |
| level 4 | 4 | 4 |
| level 5 | 10 | 14 |
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
| Participants | Study Group (SG) | Control Group (CG). |
|---|---|---|
| level 1 | 1 | 1 |
| level 2 | 4 | 3 |
| level 3 | 8 | 2 |
| level 4 | 4 | 6 |
| level 5 | 3 | 8 |
Collected over 6 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Group (SG) | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Control Group (CG). | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Customized(Participants) | Study Group (SG) | Control Group (CG). | Total |
|---|---|---|---|
| Age range — (18-48 months) < | 13 | 14 | 27 |
| Age range — ≥ (48 months) | 7 | 6 | 13 |
| Sex: Female, Male(Participants) | Study Group (SG) | Control Group (CG). | Total |
|---|---|---|---|
| Female | 12 | 9 | 21 |
| Male | 8 | 11 | 19 |
| Race and Ethnicity Not Collected(Participants) | Study Group (SG) | Control Group (CG). | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Study Group (SG) | Control Group (CG). | Total |
|---|---|---|---|
| Turkey | 20 | 19 | 39 |
| Syria | 0 | 1 | 1 |
| Cerebral Palsy type(Participants) | Study Group (SG) | Control Group (CG). | Total |
|---|---|---|---|
| diplegic | 3 | 1 | 4 |
| hemiplegic | 2 | 2 | 4 |
| quadriplegic | 8 | 10 | 18 |
| hypotonic | 6 | 5 | 11 |
| dyskinetic | 1 | 2 | 3 |
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Marmara University