NCT02010736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

1 month

First QC Date

December 5, 2013

Last Update Submit

December 13, 2013

Conditions

Keywords

Cerebral palsyGaitWeight BearingRehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Changes in kinematic gait parameters after five minutes of rest

    After five minutes of rest (FOLLOW UP phase)

Study Arms (1)

Spastic Hemiparetic Cerebral Palsy

EXPERIMENTAL

Single treadmill gait training with additional loading

Other: Single treadmill gait training with additional loading

Interventions

Spastic Hemiparetic Cerebral Palsy

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande do Norte

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

Location

Related Links

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Camila R Simão, MSc

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 13, 2013

Study Start

September 1, 2012

Primary Completion

October 1, 2012

Study Completion

November 1, 2012

Last Updated

December 16, 2013

Record last verified: 2013-12

Locations