NCT04981964

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

June 25, 2021

Last Update Submit

May 23, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • Trunk imbalance

    It represented the lateral deviation of the vertebra prominence from the dimple midpoint. It is measured in millimeters.

    Change from Baseline Trunk imbalance at 3 months

  • Lateral deviation

    The root mean square (RMS) lateral deviation of the spinal midline from the line VP-DM. It is measured in millimeters

    Change from Baseline Lateral deviation at 3 months

  • Pelvic tilt

    The pelvic tilt refers to a height difference of the lumber dimples relative to a horizontal plane. It is measured in millimeters

    Change from Baseline Pelvic tilt at 3 months

  • Surface rotation

    The root mean square (RMS) value of the surface rotation on the symmetry line (in degrees).

    Change from Baseline Surface rotation at 3 months

  • Pelvic torsion

    It is the twisting of the pelvis about a transverse axis (in degrees).

    Change from Baseline Pelvic torsion at 3 months

Secondary Outcomes (1)

  • Mobility function

    Change from Baseline dynamic gait index at 3 months

Study Arms (2)

Conventional physical therapy plus forward walking

EXPERIMENTAL

25 minutes of the forward walking training program It is based on methods as described by Grecco et al. (2013) The children were instructed to walk at a comfortable, self-selected speed during the first and final five minutes of the session and encouraged to increase the speed during the other 15 minutes.

Procedure: Exercise training

Conventional physical therapy plus backward walking

EXPERIMENTAL

25minutes of the backward walking training It is based on methods as described by Davis (1992) Firstly, the subject is asked to take a step backwards within the parallel bar and can support him or herself with the unaffected hand as required. The therapist provides help to move the subject's leg in the correct pattern, preventing subject from moving the leg back in full extension, when the subject can move the leg back with the correct pattern, the therapist gradually reduces the amount of assistance. Secondly, as the movement components have been practiced and the subjects has taken over actively with only slight help, the therapist facilitates walking backward within the parallel bars. Thirdly, the subject walks backwards actively away from the parallel bars. Finally, the distance and speed of walking backwards is progressively increased.

Procedure: Exercise training

Interventions

both groups received conventional physiotherapy training program, for one hour, three sessions per week, for three successive months, based on neurodevelopmental treatment, composed of approximation of the upper and lower limbs in a regular and rhythmic manner, facilitation of righting, equilibrium and protective reactions, training of postural stability and equal weight shift especially on the affected side, stretching, strengthening exercises for upper and lower limbs and back muscles

Conventional physical therapy plus backward walkingConventional physical therapy plus forward walking

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, None Selected, 12611, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Amr A Abdel-aziem, Ph.D

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Biomechanics

Study Record Dates

First Submitted

June 25, 2021

First Posted

July 29, 2021

Study Start

August 1, 2021

Primary Completion

October 30, 2021

Study Completion

October 30, 2021

Last Updated

May 25, 2022

Record last verified: 2022-05

Locations