Segmental Trunk Stability Training on Sitting and Upper Limbs Functions in Children With Spastic Cerebral Palsy

Effect of Segmental Trunk Stability Training on Sitting and Upper Limbs Functions in Children With Spastic Cerebral Palsy

The study aims to:

1. Investigate the effect of segmental trunk stability training on sitting in children with spastic CP.
2. Investigate the effect of segmental trunk stability training on upper limbs functions in children with spastic CP.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Traditional Physical Therapy program; Other: Segmental trunk training A; Other: Segmental trunk training B; Other: Segmental trunk training C

Detailed Description

Postural dysfunction is one of the most limiting factors in children with CP. It restricts reaching skills and in turn reduces participation in activities of daily living.

The trunk plays a key role in maintaining the postural control mechanism and also in the organization of balance reactions in this developmental process. The trunk control is also required for a stable base of support which is necessary to execute functional activities for limb movements.

The optimal level of trunk support for a child with spastic CP still remains unknown. Thus, providing intermediate levels of trunk stabilization would be a better solution than providing full support in children with CP. Innovation is necessary to improve outcomes for children with moderate to- severe CP who are at level IV and V on GMFCS. However, these children are often excluded from posture research . Very little research has examined postural constraints in children with moderate-to-severe CP.

As there is a lack of tools used in precise trunk stabilization during training, a further researches are needed. Recently, a special attention has been given to the segmental trunk control and its effects on improvement of gross and fine motor skills. Most of previous studies have been applied during segmental fixation of the trunk at multiple levels from static position either sitting or standing. In the present study, the effect of external segmental stabilization of the trunk at selected parts will be monitored during the active training and participation of the child.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Arafat, MSc; Phone Number: +201222683664; Email: marafat@horus.edu.eg

Study Locations

• Egypt
  • Damietta, Egypt
    • Recruiting
    • Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt
    • Contact: Mohamed Arafat; Phone Number: +201222683664; Email: marafat@horus.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Children with spastic CP, their chronological age will be ranged from 2 years to 4 years.
2. Their level of motor function will be 4 or 5 according to Gross Motor Function Classification System - Expanded and Revised
3. The degree of spasticity for these children will ranged from grade 1 to 2 according to Modified Ashworth Scale
4. All children's level of segmental trunk control will be level 3 according to Segmental Assessment of Trunk Control
5. They will be able to follow instructions during evaluation and treatment.

Exclusion Criteria:

• Any child with the following criteria will be directly excluded from the evaluation for the consistency of the sample and statistically obtained results: 1. Surgical interference in upper limbs and/or spine that may restrain the child performance during activities.2. Orthopedic problems or fixed deformities in the vertebral column and/or upper extremities. 3. Uncontrolled seizures. 4. Visual or hearing impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Segmental trunk training A; Children in this group will receive specially designed physical therapy program while wearing a segmental trunk support from the level of pelvis to a level just below the rib cage.	Other: Traditional Physical Therapy program; Facilitation of head control will be conducted.; Facilitation of trunk control will be applied; Facilitation of rolling; Facilitation of righting, protective and equilibrium reactions from supine, prone and sitting on a ball; Stretching exercises for the muscles liable to be tight; Facilitation of sitting; Other: Segmental trunk training A; Group (A) will wear an external segmental trunk support extended from the level of pelvis to a level just below the rib cage.
Active Comparator: Segmental trunk training B; Children in this group will receive the same program given to (group A) while wearing a segmental trunk support from the level of pelvis to a level just below the inferior angle of scapula.	Other: Traditional Physical Therapy program; Facilitation of head control will be conducted.; Facilitation of trunk control will be applied; Facilitation of rolling; Facilitation of righting, protective and equilibrium reactions from supine, prone and sitting on a ball; Stretching exercises for the muscles liable to be tight; Facilitation of sitting; Other: Segmental trunk training B; Group (B) will receive the same program given to (group A) while wearing an external segmental trunk support extended from the level of pelvis to a level just below the inferior angle of scapula.
Active Comparator: Segmental trunk training C; will receive the same program given to (group A and B) while wearing a segmental trunk support from the level of last rib to the level of the inferior angle of scapula.	Other: Traditional Physical Therapy program; Facilitation of head control will be conducted.; Facilitation of trunk control will be applied; Facilitation of rolling; Facilitation of righting, protective and equilibrium reactions from supine, prone and sitting on a ball; Stretching exercises for the muscles liable to be tight; Facilitation of sitting; Other: Segmental trunk training C; Group (C) will receive the same program given to (group A and B) while wearing an external segmental trunk support extended from the level of last rib to the level of the inferior angle of scapula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the change in gross motor function - sitting domain	Assessment via using gross motor functional measurement scale is an assessment tool designed and evaluated to measure changes in gross motor function over time or with intervention in children with cerebral palsy.	Baseline and after 6 months post intervention
Assessing the change in segmental trunk control	Assessment via using Segmental Assessment of Trunk Control (SATCo) is a validated and internationally recognized measurement tool.	Baseline and after 6 months post intervention
Assessing the change in upper limb functions	Assessment via using Quality of Upper Extremity Skills Test (QUEST) is a 34-item observational criterion-referenced test consisting of four subsections: dissociated movement, grasp, weight bearing, and protective extension. Items are related to quality of movement, not to chronological age.	Baseline and after 6 months post intervention

Collaborators and Investigators

• Sponsor: Horus University
• Investigators: Principal Investigator: Mohamed Arafat, Assistant Lecturer, Horus University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: Arafat_phd

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No