Clinical trial NCT04981964: Altered Back Geometry and Mobility Function After Backward Walking Training in Children With Cerebral Palsy
Official title: Effect of Forward Versus Backward Walking Training on Back Geometry and Mobility Function in Children With Cerebral Palsy: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 33
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PURPOSE: To assess the effect of backward walking training on back geometry and mobility function in children with hemiparetic cerebral palsy through a comparative analysis with forward walking training.

BACKGROUND:

Spinal deformities are important orthopaedic problems among children with cerebral palsy. A detailed evaluation of all these areas when the child first arrives for treatment is essential. The majority of research in children with CP is focused on assessment and treatment of upper and lower extremities. In contrast, literature on trunk control in children with CP is scarce. Although proximal trunk control is a prerequisite for improving balance and weight symmetry, there is a lack of studies that reported the role of forward and backward walking training in treating the trunk for children with CP. Therefore, the purpose of this study will investigate the role of backward walking training in addition to conventional physiotherapy program on back geometry and mobility function in children with spastic hemiparetic cerebral palsy.

HYPOTHESES: The null hypothesis of this study could be stated as: There will be no statistically significant difference in back geometry and mobility function after adding backward walking training to conventional physical therapy program in spastic hemiparetic cerebral palsy children compared with forward walking training.

RESEARCH QUESTION: Do adding backward walking training to conventional physical therapy program improves back geometry and functional mobility in children with hemiparetic cerebral palsy?

Detailed description: Introduction:

Cerebral palsy (CP) describes a group of permanent disorders of the development of movement and posture, causing activity limitation. It is the most common cause of physical disability during childhood that affects the child on several health dimensions including neuromuscular deficits, such as spasticity, muscle weakness, and decreased selective motor control, and secondary musculoskeletal problems such as bony malformations and contractures.

Trunk impairment is very common but an underscored feature of spastic CP that affects the upper and lower extremity motor functions as well. Impairments associated with the trunk seen in children with CP include but are not limited with decreased stability of the head and trunk, shoulder protraction, spinal curve deviations, and trunk muscle weakness. Inadequate control of trunk muscles leads to compensation of other muscles to maintain the upright posture. Inability of proximal stabilization and increased activation of extremity muscles during postural adjustments reduces their functionality during extremity movements.

Trunk control is the initial frame of reference for postural control; it involves stabilization through selective movements of the trunk. Although trunk control strategies vary depending on the task and the environment, all functional tasks require adequate trunk control. Without the trunk as a stable center, selective movements of the extremities and of the head are profoundly impaired. In children, trunk control ensures the acquisition of basic gross motor skills in order to develop the goal-directed activities that are essential for independent life at home and in the community.

Evaluation of the CP child's passive and active movement of the trunk is an essential part of the evaluation because mobility of the spine in all planes is necessary for correct alignment, smooth and asymmetric movements of the spine and for full range of motion of the extremities. The therapist must document any deviation from normal, note scoliosis, excessive kyphosis and lordosis and whether the curves are structural or functional.

The majority of research in children with CP is focused on assessment and treatment of upper and lower extremities. In contrast, literature on trunk control in children with CP is scarce. Although proximal trunk control is a prerequisite for improving balance and weight symmetry, there is a lack of studies that reported the role of forward and backward walking training in treating the trunk for children with CP.

Material and methods

Subjects:

A thirty-eight spastic hemiparetic cerebral palsied children of both sexes will participate in this study. The participants will be selected from the out-patient clinic of faculty of physical therapy, Cairo university. All participants will be selected according to the following inclusive criteria: Their age ranged from 5 to 7 years, with average height around one meter or more as it is the suitable height for Formetric measures (because the horizontal line which appears on the computer screen when the camera is ready for recording should be below the scapula to avoid the un-detection of the axillary points which will interfere with recording of the spinal image). They were able to stand alone independently and have the ability to walk both forward and backward over ground without an assistive device. They were able to understand and follow verbal command. They will be classified as I or II by gross motor function classification system (GMFCS). The degree of spasticity in the involved lower extremity according to Modified Ashworth Scale ranged between grades 1, 1+ and 2. Exclusion criteria for all participants will be neurological or orthopedic surgery in the last 12 months, uncontrolled seizure disorder, visual, auditory or perceptual problems and who had any experience of backward training before the trial. This study protocol was approved by the research ethical committee of the Faculty of Physical Therapy, Cairo University (P.T.REC/012/002802) and parents will sign a consent form authorizing the child's participation.

The participants will be randomly allocated into 2 groups (group A and B). The participants of group (A) will receive physical therapy program based on neurodevelopmental treatment (NDT) approach, in addition a specially designed forward walking training program. The participants of group (B) will receive the same physical therapy program, in addition a specially designed backward walking training program.

For evaluation:

The assessment will be conducted for each child of both groups individually before and after three successive months of treatment by the same examiner who will be blinded to treatment allocation. The outcome measures will be;

1. Formetric instrument system
2. Dynamic Gait Index (DGI)

Eligibility criteria: Inclusion Criteria:

* Age ranged from 5 to 7 years
* Average height around one meter or more as it is the suitable height for formetric measures
* They were able to stand alone independently and have the ability to walk both forward and backward over ground without an assistive device.
* They were able to understand and follow verbal command. They were classified as I or II by gross motor function classification system (GMFCS).
* The degree of spasticity in the involved lower extremity according to Modified Ashworth Scale ranged between grades 1, 1+ and 2.

Exclusion Criteria:

* Neurological or orthopedic surgery in the last 12 months, uncontrolled seizure disorder, visual, auditory or perceptual problems and who had any experience of backward training before the trial.

Primary outcomes:
measure: Trunk imbalance
timeFrame: Change from Baseline Trunk imbalance at 3 months
measure: Lateral deviation
timeFrame: Change from Baseline Lateral deviation at 3 months
measure: Pelvic tilt
timeFrame: Change from Baseline Pelvic tilt at 3 months
measure: Surface rotation
timeFrame: Change from Baseline Surface rotation at 3 months
measure: Pelvic torsion
timeFrame: Change from Baseline Pelvic torsion at 3 months
Secondary outcomes:
measure: Mobility function
timeFrame: Change from Baseline dynamic gait index at 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
state: None Selected
Study officials:
affiliation: Cairo University
name: Amr A Abdel-aziem, Ph.D
role: STUDY_CHAIR
References: