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Completed

NCT Number: NCT02010736

Loading Gait in Spatic 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.

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Key information

Conditions

Spastic Hemiplegic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal do Rio Grande do Norte

Natal, Rio Grande do Norte, 59072-970, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single treadmill gait training with additional loading

Other

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio Grande do Norte

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

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

Acronym: SCP

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 13, 2013
Registry last updated
Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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