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

NCT ID: NCT04937439

Last Updated: 2021-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Traditional Physical Therapy program

Intervention Type 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

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Traditional Physical Therapy program

Intervention Type 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 B

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Traditional Physical Therapy program

Intervention Type 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 C

Intervention Type 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.

Interventions

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Traditional Physical Therapy program

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

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Horus University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Arafat

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Arafat, Assistant Lecturer

Role: PRINCIPAL_INVESTIGATOR

Horus University, Egypt

Locations

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

Damietta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Arafat, MSc

Role: CONTACT

+201222683664

Facility Contacts

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Mohamed Arafat

Role: primary

+201222683664

Other Identifiers

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Arafat_phd

Identifier Type: -

Identifier Source: org_study_id

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