NCT04081675

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
3.1 years until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

September 2, 2019

Last Update Submit

April 21, 2021

Conditions

Cerebral Palsy

Keywords

orthoticsgait analysis

Outcome Measures

Primary Outcomes (4)

  • 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

Interventions

Ankle Foot Orthosis (AFO)DEVICE

Thermoplastic orthotic device spanning the calf, ankle and foot.

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with cerebral palsy

You may qualify if:

  • Diagnosis of spastic diplegia or hemiplegia GMFCS level 1 or 2 (ie independently mobile) Gait pattern compatible with achieving clean foot strikes on the force platforms in the gait laboratory.
  • Able to understand sufficiently to co-operate happily with the gait analysis process and participate in the interviews.
  • In main stream education

You may not qualify if:

  • Any behavioural or communication problems which would make them unable to comply with the protocol.
  • Any invasive procedures (eg surgery, Botulinum toxin injections) in the previous 6 months.
  • Any invasive procedures (eg surgery, Botulinum toxin injections) planned in the next 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ORLAU, RJAH Orthopaedic Hospital

Oswestry, Shropshire, SY10 7AG, United Kingdom

Location

Related Publications (10)

  • 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.

    PMID: 11221908BACKGROUND

  • 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.

    PMID: 19263554BACKGROUND

  • 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.

    PMID: 17718819BACKGROUND

  • 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.

    PMID: 25091031BACKGROUND

  • 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.

    PMID: 25711842BACKGROUND

  • Prevalence and characteristics of children with cerebral palsy in Europe. Dev Med Child Neurol. 2002 Sep;44(9):633-40.

    PMID: 12227618BACKGROUND

  • 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.

    PMID: 26195302BACKGROUND

  • 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.

    PMID: 16772110BACKGROUND

  • 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.

    PMID: 24714702BACKGROUND

  • 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.

    PMID: 25274143BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Dr C Stewart, PhD

    RJAH Orthopaedic Hospital/Keele University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr C Stewart, PhD

CONTACT

0044 1691 404666caroline.stewart9@nhs.net

Teresa Jones

CONTACT

0044 1691 404143teresa.jones6@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2019

First Posted

September 9, 2019

Study Start

September 30, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

April 22, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)