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Loading Gait in Spatic Cerebral Palsy (SCP)

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ClinicalTrials.gov Identifier: NCT02010736
Recruitment Status : Completed
First Posted : December 13, 2013
Last Update Posted : December 16, 2013
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Ana Raquel Rodrigues Lindquist, Universidade Federal do Rio Grande do Norte

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Spastic Hemiplegic Cerebral Palsy Other: Single treadmill gait training with additional loading Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Effects of a Single Treadmill Gait Training Session With Additional Loading on Kinematic Gait Parameters in Children With Spastic Cerebral Palsy
Study Start Date : September 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Spastic Hemiparetic Cerebral Palsy
Single treadmill gait training with additional loading
Other: Single treadmill gait training with additional loading



Primary Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010736


Locations
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Brazil
Universidade Federal do Rio Grande do Norte
Natal, RN, Brazil, 59072-970
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
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Principal Investigator: Camila R Simão, MSc Universidade Federal do Rio Grande do Norte
Additional Information:
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Responsible Party: Ana Raquel Rodrigues Lindquist, PhD, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT02010736    
Other Study ID Numbers: CEP-UFRN 76519/2012
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: December 2013
Keywords provided by Ana Raquel Rodrigues Lindquist, Universidade Federal do Rio Grande do Norte:
Cerebral palsy
Gait
Weight Bearing
Rehabilitation
Additional relevant MeSH terms:
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Muscle Spasticity
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations