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Loading Gait in Spatic Cerebral Palsy (SCP)

Primary Purpose

Spastic Hemiplegic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Single treadmill gait training with additional loading
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Hemiplegic Cerebral Palsy focused on measuring Cerebral palsy, Gait, Weight Bearing, Rehabilitation

Eligibility Criteria

5 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal do Rio Grande do Norte

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spastic Hemiparetic Cerebral Palsy

Arm Description

Single treadmill gait training with additional loading

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
December 5, 2013
Last Updated
December 13, 2013
Sponsor
Universidade Federal do Rio Grande do Norte
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT02010736
Brief Title
Loading Gait in Spatic Cerebral Palsy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Hemiplegic Cerebral Palsy
Keywords
Cerebral palsy, Gait, Weight Bearing, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spastic Hemiparetic Cerebral Palsy
Arm Type
Experimental
Arm Description
Single treadmill gait training with additional loading
Intervention Type
Other
Intervention Name(s)
Single treadmill gait training with additional loading
Primary Outcome Measure Information:
Title
Changes in kinematic gait parameters after treadmill trainning with ankles loading
Description
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).
Time Frame
Immediately after training with ankles loading (POST phase)
Secondary Outcome Measure Information:
Title
Changes in kinematic gait parameters after five minutes of rest
Description
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.
Time Frame
After five minutes of rest (FOLLOW UP phase)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camila R Simão, MSc
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Norte
City
Natal
State/Province
RN
ZIP/Postal Code
59072-970
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v%3Aproject=medlineplus&query=cerebral+palsy&x=10&y=9
Description
Cerebral palsy
URL
http://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v%3Aproject=medlineplus&query=gait+training&x=14&y=21
Description
Gait training

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Loading Gait in Spatic Cerebral Palsy

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