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

NCT04937439 | Unknown DMC

• 1 other identifier: Arafat_phd
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to:

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

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Segmental trunk training A

EXPERIMENTAL

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; Other: Segmental trunk training A

Segmental trunk training B

ACTIVE COMPARATOR

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; Other: Segmental trunk training B

Segmental trunk training C

ACTIVE COMPARATOR

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; Other: Segmental trunk training C

Interventions

Traditional Physical Therapy program OTHER

1. Facilitation of head control will be conducted. 2. Facilitation of trunk control will be applied 3. Facilitation of rolling 4. Facilitation of righting, protective and equilibrium reactions from supine, prone and sitting on a ball 5. Stretching exercises for the muscles liable to be tight 6. Facilitation of sitting

Segmental trunk training A; Segmental trunk training B; Segmental trunk training C

Segmental trunk training A OTHER

Group (A) will wear an external segmental trunk support extended from the level of pelvis to a level just below the rib cage.

Segmental trunk training A

Segmental trunk training B OTHER

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.

Segmental trunk training B

Segmental trunk training C OTHER

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.

Segmental trunk training C

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

Outpatient clinic, faculty of Physical Therapy, Horus University, Egypt

Damietta, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mohamed Arafat, Assistant Lecturer

  Horus University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Arafat, MSc

CONTACT

+201222683664; marafat@horus.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 24, 2021
• Study Start: January 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)