Loading Gait in Spatic Cerebral Palsy (SCP)

• ClinicalTrials.gov Identifier: NCT02010736
• Recruitment Status: Completed
• First Posted: December 13, 2013
• Last Update Posted: December 16, 2013
• Sponsor: Universidade Federal do Rio Grande do Norte
• 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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

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

More Information

Additional Information:

Cerebral palsy 

Gait training 

• 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
• 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:

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