NCT04214080

Effect of Trunk Stabilization Exercises on Quality of Life and Communication in Cerebral Palsy

Completed NA Results posted Last updated 5 May 2020

What this trial tests

NA trial testing Neurodevelopmental treatment (NDT) in Cerebral Palsy in 40 participants. Completed in 5 December 2019.

Timeline

1 May 2018

Primary endpoint
31 May 2019

5 December 2019

Quick facts

Lead sponsor	Marmara University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	1 May 2018
Primary completion	31 May 2019
Estimated completion	5 December 2019
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Neurodevelopmental treatment (NDT)
• Feeding and oral-motor intervention strategies
• Neck and trunk stabilization exercises

Conditions studied

• Cerebral Palsy — all drugs for Cerebral Palsy →

Sponsor

Marmara University

Who can join

Adults 18 Months to 54 Months, any sex, with Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Visual Analogue Scale (VAS) Primary · 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

Group	Value	95% CI
Study Group (SG)	6.75	± 3.10
Control Group (CG).	5.29	± 3.33

Katz Index of Independence in Activities of Daily Living (ADL) Primary · 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.

Group	Value	95% CI
Study Group (SG)	0.70	± 1.26
Control Group (CG).	0.55	± 1.39

Pediatric Quality of Life Inventory (PedsQL). Version 4.0- Parent Report for Toddlers (Ages 2-4) Primary · 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.

Group	Value	95% CI
Study Group (SG)	48.42	± 18.33
Control Group (CG).	53.48	± 20.28

Short Form 36 Questionnaire (SF-36) Primary · 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

Group	Value	95% CI
Study Group (SG)	80.25	± 26.97
Control Group (CG).	81.75	± 17.93

Viking Speech Scale (VSS) Primary · Change from VSS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).

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.

Group	Value	95% CI
Study Group (SG)	3.14	± 1.06
Control Group (CG).	3.50	± 0.837

Gross Motor Function Classification System (GMFCS) Primary · 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.

Group	Value	95% CI
Study Group (SG)	4
Control Group (CG).	2
Study Group (SG)	0
Control Group (CG).	0
Study Group (SG)	2
Control Group (CG).	0
Study Group (SG)	4
Control Group (CG).	4

Communication Function Classification System (CFCS) Primary · 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

Group	Value	95% CI
Study Group (SG)	1
Control Group (CG).	1
Study Group (SG)	4
Control Group (CG).	3
Study Group (SG)	8
Control Group (CG).	2
Study Group (SG)	4
Control Group (CG).	6

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.