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- Essai clinique NCT02467829
Effects of Altering Handle Height of Posterior Walkers
What Are the Effects of Altering Handle Height of Posterior Walkers on Gait Parameters in Children With Spastic Cerebral Palsy?
Aperçu de l'étude
Statut
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
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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West Midlands
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Birmingham, West Midlands, Royaume-Uni, B15 2TT
- Recrutement
- Kinesiology Laboratory
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Contact:
- François-Xavier Li, PhD
- Numéro de téléphone: 0121 414 4114
- E-mail: F.X.Li@bham.ac.uk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
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
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 |
|---|---|
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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.
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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.
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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.
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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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Three dimensional gait analysis
Délai: Half a day
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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.
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Half a day
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Force through the legs of the walker and the participants feet.
Délai: Half a day
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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.
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Half a day
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Physiological cost index
Délai: Half a day
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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
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The Faces Pain Scale -Revised
Délai: Half a day
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The participant chooses from one of 5 faces to indicate how much pain they are in.
This will be repeated at each handle height.
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Half a day
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Gross Motor function measure - 88
Délai: 1-2 hours
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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.
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1-2 hours
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Hip abductor strength
Délai: 10 mins
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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).
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10 mins
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Posterior walker 180 degree turn test
Délai: 5 mins
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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.
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5 mins
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Marilyn Poole, BSc, Birmingham Community Healthcare NHS Trust
Publications et liens utiles
Publications générales
- Tomlinson D, von Baeyer CL, Stinson JN, Sung L. A systematic review of faces scales for the self-report of pain intensity in children. Pediatrics. 2010 Nov;126(5):e1168-98. doi: 10.1542/peds.2010-1609. Epub 2010 Oct 4.
- Greiner BM, Czerniecki JM, Deitz JC. Gait parameters of children with spastic diplegia: a comparison of effects of posterior and anterior walkers. Arch Phys Med Rehabil. 1993 Apr;74(4):381-5.
- Logan L, Byers-Hinkley K, Ciccone CD. Anterior versus posterior walkers: a gait analysis study. Dev Med Child Neurol. 1990 Dec;32(12):1044-8. doi: 10.1111/j.1469-8749.1990.tb08521.x.
- Mattsson E, Andersson C. Oxygen cost, walking speed, and perceived exertion in children with cerebral palsy when walking with anterior and posterior walkers. Dev Med Child Neurol. 1997 Oct;39(10):671-6. doi: 10.1111/j.1469-8749.1997.tb07361.x.
- Park ES, Park CI, Kim JY. Comparison of anterior and posterior walkers with respect to gait parameters and energy expenditure of children with spastic diplegic cerebral palsy. Yonsei Med J. 2001 Apr;42(2):180-4. doi: 10.3349/ymj.2001.42.2.180.
- Konop KA, Strifling KM, Wang M, Cao K, Schwab JP, Eastwood D, Jackson S, Ackman JD, Harris GF. A biomechanical analysis of upper extremity kinetics in children with cerebral palsy using anterior and posterior walkers. Gait Posture. 2009 Oct;30(3):364-9. doi: 10.1016/j.gaitpost.2009.06.012. Epub 2009 Jul 18.
- Konop KA, Strifling KM, Wang M, Cao K, Eastwood D, Jackson S, Ackman J, Altiok H, Schwab J, Harris GF. [Upper extremity kinetics and energy expenditure during walker-assisted gait in children with cerebral palsy]. Acta Orthop Traumatol Turc. 2009 Mar-Apr;43(2):156-64. doi: 10.3944/AOTT.2009.156. Turkish.
- Raja K, Joseph B, Benjamin S, Minocha V, Rana B. Physiological cost index in cerebral palsy: its role in evaluating the efficiency of ambulation. J Pediatr Orthop. 2007 Mar;27(2):130-6. doi: 10.1097/01.bpb.0000242440.96434.26.
- Ketelaar M, Vermeer A, Helders PJ. Functional motor abilities of children with cerebral palsy: a systematic literature review of assessment measures. Clin Rehabil. 1998 Oct;12(5):369-80. doi: 10.1191/026921598673571117.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RG_15-057
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