Loading Gait in Spatic Cerebral Palsy

Spastic Hemiplegic Cerebral Palsy Clinical Trial

— SCP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010736
• Other study ID #: CEP-UFRN 76519/2012
• Status: Completed
• Phase: N/A
• First received: December 5, 2013
• Last updated: December 13, 2013
• Start date: September 2012
• Est. completion date: November 2012

Study information

• Verified date: December 2013
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 13 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Spastic Hemiplegic Cerebral Palsy

Intervention

Other:
• Single treadmill gait training with additional loading

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio Grande do Norte	Natal	RN

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in kinematic gait parameters after treadmill trainning with ankles loading	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)	No
Secondary	Changes in kinematic gait parameters after five minutes of rest	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)	No

External Links

•   Cerebral palsy
•   Gait training