Understanding the Factors Affecting Compliance in Children With Cerebral Palsy Supplied With Ankle Foot Orthoses (AFOs) Using Quantitative Measurement of Function and Qualitative Evaluation of Experience and Wellbeing
Sponsor study identifier
observational
4
1 country
1
Study Start
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Children with cerebral palsy are frequently supplied with Ankle Foot Orthoses (AFOs) to aid their walking. There are huge benefits to patients in staying physically active into adulthood but this becomes more challenging as children progress through adolescence. It is possible to measure the functional benefits of AFO use, however the investigators suspect the correlation with patient compliance is poor. By combining quantitative analysis using 3D gait analysis with qualitative exploration of children's experience the investigators hope to gain a better understanding of the factors influencing children's compliance. This compliance will be measured using sensors mounted in the AFOs, over a 3 month period. The investigators hope this research will help clinicians manage patients better and also inform changes in splint design.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2, 2019
Actual (reported)September 9, 2019
Actual (reported)September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Walking speed (m/s)
This will be measured in a clinical movement analysis laboratory using timing gates at either end of the walkway.
At baseline
Gait Profile Score (GPS) in degrees
A 3D movement analysis system will be used to record the full kinematics and kinetics of the child's gait with and without AFOs. The outcome measure extracted will be the GPS, which documents the average deviation in joint angles (in degrees) across multiple joints compared with an unimpaired control cohort. Unimpaired data are already available in the host unit.
At baseline
Compliance (minutes per day)
The compliance will be recorded using Orthotimer sensors embedded in the body of the AFO. The sensors record usage throughout the day in 15min intervals.
At end of 3 months of use
Patient Experience
Qualitative interviews - an entirely qualitative approach will be used to draw out narrative themes. No scoring scale is used.
At end of 3 months of use
Thermoplastic orthotic device spanning the calf, ankle and foot.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Children with cerebral palsy
ORLAU, RJAH Orthopaedic Hospital
Oswestry, Shropshire, SY10 7AG, United Kingdom
Andersson C, Mattsson E. Adults with cerebral palsy: a survey describing problems, needs, and resources, with special emphasis on locomotion. Dev Med Child Neurol. 2001 Feb;43(2):76-82. doi: 10.1017/s0012162201.
Butler PB, Farmer SE, Stewart C, Jones PW, Forward M. The effect of fixed ankle foot orthoses in children with cerebral palsy. Disabil Rehabil Assist Technol. 2007 Jan;2(1):51-8. doi: 10.1080/17483100600662009.
Dr C Stewart, PhD
RJAH Orthopaedic Hospital/Keele University
First Submitted
September 2, 2019
First Posted
September 9, 2019
Study Start
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2023
Medium to Long Term Outcomes of Selective Dorsal Rhizotomy
Contact the study team to confirm eligibility.
Day SM, Wu YW, Strauss DJ, Shavelle RM, Reynolds RJ. Change in ambulatory ability of adolescents and young adults with cerebral palsy. Dev Med Child Neurol. 2007 Sep;49(9):647-53. doi: 10.1111/j.1469-8749.2007.00647.x.
Gabb J, Singh R. The uses of emotion maps in research and clinical practice with families and couples: methodological innovation and critical inquiry. Fam Process. 2015 Mar;54(1):185-97. doi: 10.1111/famp.12096. Epub 2014 Aug 5.
Hayles E, Harvey D, Plummer D, Jones A. Parents' Experiences of Health Care for Their Children With Cerebral Palsy. Qual Health Res. 2015 Aug;25(8):1139-54. doi: 10.1177/1049732315570122. Epub 2015 Feb 23.
Prevalence and characteristics of children with cerebral palsy in Europe. Dev Med Child Neurol. 2002 Sep;44(9):633-40.
Koldoff EA, Holtzclaw BJ. Physical Activity Among Adolescents with Cerebral Palsy: An Integrative Review. J Pediatr Nurs. 2015 Sep-Oct;30(5):e105-17. doi: 10.1016/j.pedn.2015.05.027. Epub 2015 Jul 18.
Krakovsky G, Huth MM, Lin L, Levin RS. Functional changes in children, adolescents, and young adults with cerebral palsy. Res Dev Disabil. 2007 Jul-Sep;28(4):331-40. doi: 10.1016/j.ridd.2006.03.005.
Nooijen C, Slaman J, van der Slot W, Stam H, Roebroeck M, van den Berg-Emons R; Learn2Move Research Group. Health-related physical fitness of ambulatory adolescents and young adults with spastic cerebral palsy. J Rehabil Med. 2014 Jul;46(7):642-7. doi: 10.2340/16501977-1821.
Wingstrand M, Hagglund G, Rodby-Bousquet E. Ankle-foot orthoses in children with cerebral palsy: a cross sectional population based study of 2200 children. BMC Musculoskelet Disord. 2014 Oct 2;15:327. doi: 10.1186/1471-2474-15-327.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 22, 2021
Record last verified: 2021-04
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