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

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Traditional Physical Therapy program
Segmental trunk training A
Segmental trunk training B
Segmental trunk training C
Sponsored by
Horus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

2 Years - 4 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Outpatient clinic, faculty of Physical Therapy, Horus University, EgyptRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Segmental trunk training A

Segmental trunk training B

Segmental trunk training C

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
Assessing the change in segmental trunk control
Assessment via using Segmental Assessment of Trunk Control (SATCo) is a validated and internationally recognized measurement tool.
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.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2021
Last Updated
June 16, 2021
Sponsor
Horus University
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1. Study Identification

Unique Protocol Identification Number
NCT04937439
Brief Title
Segmental Trunk Stability Training on Sitting and Upper Limbs Functions in Children With Spastic Cerebral Palsy
Official Title
Effect of Segmental Trunk Stability Training on Sitting and Upper Limbs Functions in Children With Spastic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Horus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study aims to: Investigate the effect of segmental trunk stability training on sitting in children with spastic CP. Investigate the effect of segmental trunk stability training on upper limbs functions in children with spastic CP.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Segmental trunk training A
Arm Type
Experimental
Arm Description
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.
Arm Title
Segmental trunk training B
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Segmental trunk training C
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional Physical Therapy program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Segmental trunk training A
Intervention Description
Group (A) will wear an external segmental trunk support extended from the level of pelvis to a level just below the rib cage.
Intervention Type
Other
Intervention Name(s)
Segmental trunk training B
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Segmental trunk training C
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessing the change in gross motor function - sitting domain
Description
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.
Time Frame
Baseline and after 6 months post intervention
Title
Assessing the change in segmental trunk control
Description
Assessment via using Segmental Assessment of Trunk Control (SATCo) is a validated and internationally recognized measurement tool.
Time Frame
Baseline and after 6 months post intervention
Title
Assessing the change in upper limb functions
Description
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.
Time Frame
Baseline and after 6 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Arafat, MSc
Phone
+201222683664
Email
marafat@horus.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Arafat, Assistant Lecturer
Organizational Affiliation
Horus University, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic, faculty of Physical Therapy, Horus University, Egypt
City
Damietta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Arafat
Phone
+201222683664
Email
marafat@horus.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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

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