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Effects of Altering Handle Height of Posterior Walkers

7 janvier 2016 mis à jour par: University of Birmingham

What Are the Effects of Altering Handle Height of Posterior Walkers on Gait Parameters in Children With Spastic Cerebral Palsy?

The aims of this study are to investigate what effect altering handle height of posterior walkers has on forces through the walker, posture, efficiency, stability, speed, turning and comfort, and to obtain data which helps therapists understand the bio-mechanics involved during use and if this alters depending on age, posture or strength. All participants will have cerebral palsy. This will allow informed prescription of walkers and identify potential for redesign to improve efficiency, promote strengthening or improve posture to maximise children's potential to continue functional walking into adulthood.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

Children with cerebral palsy (CP) find walking effortful due to weakness, lack of coordination between muscle groups, postural changes, poor balance and altered muscle tone. Walking aids improve efficiency, stability and posture.Posterior walkers were developed in the mid 1980's. There is evidence of their advantages over more traditional anterior walkers, however there is no evidence relating to setting handle height, and little information about bio-mechanics during use.

This is a quantitative pilot study with a cross over design. A purposive sample of approximately 15 children will be recruited from Birmingham Community Healthcare National Health Service (NHS) Trust. Assessments will be carried out at 3 different handle heights, determined by measuring elbow flexion when the participant is standing holding the handles of their walker. Participants will attend two assessments. One at their school, and a second at the University of Birmingham. Forces going through the walker and the participant's feet, range of motion at the trunk, hip and knee, velocity, step and stride length, double support time, physiological cost index, pain, gross motor function, hip abductor strength and ease of turning will be measured.

Analysis of variance with repeated measures will be used to analyse changes across handle heights and multiple linear regression to show associations between the dependent variables studied and identify potential confounding factors. p<0.05 will be considered statistically significant. Effect sizes needed for clinical significance will be considered.

Type d'étude

Interventionnel

Inscription (Anticipé)

15

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • West Midlands
      • Birmingham, West Midlands, Royaume-Uni, B15 2TT
        • Recrutement
        • Kinesiology Laboratory
        • Contact:
          • François-Xavier Li, PhD
          • Numéro de téléphone: 0121 414 4114
          • E-mail: F.X.Li@bham.ac.uk

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

5 ans à 18 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Diagnosis of spastic Cerebral Palsy by a medical practitioner from clinical presentation.
  • Aged 5-18 years.
  • Able to walk 50m with a posterior walker without rest.
  • Uses a posterior walker at least once a week.

Exclusion Criteria:

  • Aged below 5 years or over 18.
  • Orthopaedic surgery in the last 6 months, serial casting or botulinum toxin injections in the 12 weeks prior to or during the study, as gait could vary significantly following these interventions.
  • Unable to walk 50m in a straight line and follow verbal prompts to turn.
  • Insufficient understanding, in the opinion of their carer or therapist, to complete Faces rating scale.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: 10° of elbow flexion
This handle height is the nearest position the walker can be set to to achieve 10° of elbow flexion. Elbow flexion is measured with the child standing in their walker using an electronic goniometer.
Expérimental: 30° of elbow flexion
Increase in handle height. This handle height is the nearest position the walker can be set to to achieve 30° of elbow flexion.
Elbow flexion is measured with the child standing in their walker using an electronic goniometer. Approximately 10° of elbow flexion is current recommended practice. 30° and 50° are increased handle heights.
Expérimental: 50° of elbow flexion
Increase in handle height. This handle height is the nearest position the walker can be set to to achieve 50° of elbow flexion.
Elbow flexion is measured with the child standing in their walker using an electronic goniometer. Approximately 10° of elbow flexion is current recommended practice. 30° and 50° are increased handle heights.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Three dimensional gait analysis
Délai: Half a day
Kinetic data will be captured using a 13 camera Vicon three dimensional motion analysis system. Reflective markers will be placed bilaterally on the acromion process, lateral epicondyle of the elbow, styloid process of the ulna, greater trochanter of the femur, anterior superior iliac spine, posterior superior iliac spine, lateral epicondyle of the femur, lateral malleolus, insertion of the achilles tendon and head of the fifth metatarsal. Markers will be placed on the corners of walker, at the top and bottom of it (8 in total). Trunk hip and knee angles on both sides of the body will be recorded throughout the gait cycle, as children with CP often have asymmetrical gait. Velocity, step and stride length and double support time will also be calculated using this system.
Half a day

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Force through the legs of the walker and the participants feet.
Délai: Half a day
A sensor will be placed in each of the four walker legs to measure the force going through each one. The force the participants's feet exert on the floor will be measured as they cross the force plate.
Half a day
Physiological cost index
Délai: Half a day

This measures efficiency of gait in beats per metre.It is calculated using the following formula:

Walking heart rate-resting heart rate/walking speed. Heart rate is measured in beats/minute and speed in metres/minute. Heart rate will be continuously monitored electronically. It will be calculated over a distance of 50m.

Half a day
The Faces Pain Scale -Revised
Délai: Half a day
The participant chooses from one of 5 faces to indicate how much pain they are in. This will be repeated at each handle height.
Half a day
Gross Motor function measure - 88
Délai: 1-2 hours
Used to assess change in gross motor function over time in children with CP. Participants are asked to do a series of simple tasks across 5 domains of lying and rolling, sitting, crawling and kneeling, standing, walking running and jumping.
1-2 hours
Hip abductor strength
Délai: 10 mins
Hip abductor strength will be measured in supine lying using a Kin Com dynamometer, as previously described by Engsberg at al (Engsberg et al., 2002).
10 mins
Posterior walker 180 degree turn test
Délai: 5 mins
This test has been designed for the purposes of this study. A line is taped on the floor perpendicular to the direction in which the participant is walking. They approach the line from a minimum of 3m away and turn when they reach the line. Direction of the turn (clockwise/anticlockwise), time and number of steps taken to turn 180 degrees is recorded.
5 mins

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Marilyn Poole, BSc, Birmingham Community Healthcare NHS Trust

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2016

Achèvement primaire (Anticipé)

1 avril 2016

Achèvement de l'étude (Anticipé)

1 septembre 2016

Dates d'inscription aux études

Première soumission

5 juin 2015

Première soumission répondant aux critères de contrôle qualité

8 juin 2015

Première publication (Estimation)

10 juin 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

8 janvier 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 janvier 2016

Dernière vérification

1 janvier 2016

Plus d'information

Termes liés à cette étude

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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