Clinical trial NCT02467829: Effects of Altering Handle Height of Posterior Walkers
Official title: What Are the Effects of Altering Handle Height of Posterior Walkers on Gait Parameters in Children With Spastic Cerebral Palsy?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Walking Aids
Lead sponsor: University of Birmingham
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Three dimensional gait analysis
timeFrame: Half a day
Secondary outcomes:
measure: Force through the legs of the walker and the participants feet.
timeFrame: Half a day
measure: Physiological cost index
timeFrame: Half a day
measure: The Faces Pain Scale -Revised
timeFrame: Half a day
measure: Gross Motor function measure - 88
timeFrame: 1-2 hours
measure: Hip abductor strength
timeFrame: 10 mins
measure: Posterior walker 180 degree turn test
timeFrame: 5 mins
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Kinesiology Laboratory
state: West Midlands
Study officials:
affiliation: Birmingham Community Healthcare NHS Trust
name: Marilyn Poole, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.