Loading Gait in Spatic Cerebral Palsy (SCP)

December 13, 2013 updated by: Ana Raquel Rodrigues Lindquist, Universidade Federal do Rio Grande do Norte

Immediate Effects of a Single Treadmill Gait Training Session With Additional Loading on Kinematic Gait Parameters in Children With Spastic Cerebral Palsy

The purpose of this study is to observe the behavior of kinematic variables in children with spastic hemiparetic cerebral palsy (SHCP), immediately after treadmill gait training with ankle loading.

The children underwent a single treadmill training session with ankle loading. The kinematic parameters were assessed in three phases: before training (PRE); immediately after training (POST); and 5 minutes after the end of training (FOLLOW UP).

The investigators hypothesized that the treadmill gait training with additional lower limb loading would be a disturbance capable of modifying the locomotor strategy of children with SHCP, by the increase in kinematic parameters in the swing phase of gait.

Study Overview

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • RN
      • Natal, RN, Brazil, 59072-970
        • Universidade Federal do Rio Grande do Norte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 13 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Spastic Hemiparetic Cerebral Palsy;
  • Being able to walk without an assistive device (levels I or II of the Gross Motor Function Classification System - GMFCS);
  • Not having undergone muscle lengthening surgery within the previous year;
  • Not having applied botulin toxin to the lower limbs or serial casting in the previous 6 months.

Exclusion Criteria:

  • Inability to understand simple commands to perform the training and evaluation;
  • Inability to walk on the treadmill with or without load on the lower limbs;
  • Presence of any physical pain or discomfort during the course of training.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Spastic Hemiparetic Cerebral Palsy
Single treadmill gait training with additional loading

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in kinematic gait parameters after treadmill trainning with ankles loading
Time Frame: Immediately after training with ankles loading (POST phase)

Kinematic gait data were captured by Qualisys Track Manager 1.6.0.x - QTM software and exported to Visual3D processing software, to reconstruct the segments and create a biomechanical model. It was carried out in two stages: static and dynamic collection. The dynamic collection was performed while the children walked on the electric treadmill.

The primary outcome measure was the following spatiotemporal variables at the POST phase: cadence (steps/min), stride length (m), paretic step length (m), stance time (%), swing time (%) paretic lower limb (PLL), double stance (%), symmetry ratio and stance/swing time ratio. With respect to angular variables, the following parameters was analysed: angular displacement (maximum flexion, maximum extension and range of motion) of the hip and knee were investigated (º).

Immediately after training with ankles loading (POST phase)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in kinematic gait parameters after five minutes of rest
Time Frame: After five minutes of rest (FOLLOW UP phase)

Kinematic gait data were captured by Qualisys Track Manager 1.6.0.x - QTM software and exported to Visual3D processing software, to reconstruct the segments and create a biomechanical model. It was carried out in two stages: static and dynamic collection. The dynamic collection was performed while the children walked on the electric treadmill.

The secundary outcome measure was the same spatiotemporal and angular variables investigated at the POST phase although in this condition they was analysed at FOLLOW UP phase.

After five minutes of rest (FOLLOW UP phase)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Camila R Simão, MSc, Universidade Federal do Rio Grande do Norte

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 9, 2013

First Posted (ESTIMATE)

December 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 16, 2013

Last Update Submitted That Met QC Criteria

December 13, 2013

Last Verified

December 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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