Effects of Altering Handle Height of Posterior Walkers
7 gennaio 2016 aggiornato da: 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.
Panoramica dello studio
Stato
Sconosciuto
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Anticipato)
15
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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West Midlands
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Birmingham, West Midlands, Regno Unito, B15 2TT
- Reclutamento
- Kinesiology Laboratory
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Contatto:
- François-Xavier Li, PhD
- Numero di telefono: 0121 414 4114
- Email: F.X.Li@bham.ac.uk
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 5 anni a 18 anni (Bambino, Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Nessun intervento: 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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Sperimentale: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Three dimensional gait analysis
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Force through the legs of the walker and the participants feet.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Marilyn Poole, BSc, Birmingham Community Healthcare NHS Trust
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2016
Completamento primario (Anticipato)
1 aprile 2016
Completamento dello studio (Anticipato)
1 settembre 2016
Date di iscrizione allo studio
Primo inviato
5 giugno 2015
Primo inviato che soddisfa i criteri di controllo qualità
8 giugno 2015
Primo Inserito (Stima)
10 giugno 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
8 gennaio 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 gennaio 2016
Ultimo verificato
1 gennaio 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RG_15-057
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .