Trial Outcomes & Findings for Effect of Trunk Stabilization Exercises on Quality of Life and Communication in Cerebral Palsy (NCT NCT04214080)
NCT ID: NCT04214080
Last Updated: 2020-05-05
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Change from VAS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
Results posted on
2020-05-05
Participant Flow
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
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
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).
|
Control Group (CG).
n=20 Participants
(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.
|
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: Change from VAS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).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
Outcome measures
| Measure |
Study Group (SG)
n=20 Participants
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).
|
Control Group (CG).
n=20 Participants
(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.
|
|---|---|---|
|
Visual Analogue Scale (VAS)
|
6.75 units on a scale
Standard Deviation 3.10
|
5.29 units on a scale
Standard Deviation 3.33
|
PRIMARY outcome
Timeframe: Change from Katz was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).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.
Outcome measures
| Measure |
Study Group (SG)
n=20 Participants
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).
|
Control Group (CG).
n=20 Participants
(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.
|
|---|---|---|
|
Katz Index of Independence in Activities of Daily Living (ADL)
|
0.70 score on a scale
Standard Deviation 1.26
|
0.55 score on a scale
Standard Deviation 1.39
|
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).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.
Outcome measures
| Measure |
Study Group (SG)
n=20 Participants
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).
|
Control Group (CG).
n=20 Participants
(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.
|
|---|---|---|
|
Pediatric Quality of Life Inventory (PedsQL). Version 4.0- Parent Report for Toddlers (Ages 2-4)
|
48.42 score on a scale
Standard Deviation 18.33
|
53.48 score on a scale
Standard Deviation 20.28
|
PRIMARY outcome
Timeframe: Change from SF-36 was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).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
Outcome measures
| Measure |
Study Group (SG)
n=20 Participants
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).
|
Control Group (CG).
n=20 Participants
(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.
|
|---|---|---|
|
Short Form 36 Questionnaire (SF-36)
|
80.25 score on a scale
Standard Deviation 26.97
|
81.75 score on a scale
Standard Deviation 17.93
|
PRIMARY outcome
Timeframe: Change from VSS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).Population: 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.
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.
Outcome measures
| Measure |
Study Group (SG)
n=7 Participants
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).
|
Control Group (CG).
n=6 Participants
(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.
|
|---|---|---|
|
Viking Speech Scale (VSS)
|
3.14 score on a scale
Standard Deviation 1.06
|
3.50 score on a scale
Standard Deviation 0.837
|
PRIMARY outcome
Timeframe: Immediately before the intervention, the evaluation was performed in the first session (only one time).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.
Outcome measures
| Measure |
Study Group (SG)
n=20 Participants
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).
|
Control Group (CG).
n=20 Participants
(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.
|
|---|---|---|
|
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, an evaluation was performed in the first session (only one time).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
Outcome measures
| Measure |
Study Group (SG)
n=20 Participants
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).
|
Control Group (CG).
n=20 Participants
(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.
|
|---|---|---|
|
Communication Function Classification System (CFCS)
level 1
|
1 Participants
|
1 Participants
|
|
Communication Function Classification System (CFCS)
level 2
|
4 Participants
|
3 Participants
|
|
Communication Function Classification System (CFCS)
level 3
|
8 Participants
|
2 Participants
|
|
Communication Function Classification System (CFCS)
level 4
|
4 Participants
|
6 Participants
|
|
Communication Function Classification System (CFCS)
level 5
|
3 Participants
|
8 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