Compliance in Children With Cerebral Palsy Supplied With AFOs

April 21, 2021 updated by: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background

About 1 in 400 children born in the UK has cerebral palsy (CP). CP is caused by injury to the foetal or infant brain, and results in problems with walking, balance and coordination. One of the most common strategies for treating walking limitations in children with CP is the use of Ankle Foot Orthoses (AFOs), which aim to correct deformity and improve walking efficiency.

Keeping children with CP mobile is important, not only because physical fitness contributes to quality of life, but also because lack of physical activity can result in a downwards spiral: low physical fitness can make activities of daily living more difficult, leading to further reduction in activity and fitness. One study showed that children with CP at age 10 who walked and did not use a wheelchair had only a small chance (11%) of becoming non-ambulatory, vs. 34% of children using a wheelchair.

AFOs can play an important part in keeping children with CP mobile, and reducing the need for a wheelchair. However, there is evidence that when they reach adolescence, some children are reluctant to wear their AFOs. One of the parents participating in a previous study said "... now we have a 13-year-old who just wants to be like other 13- year-old girls, and she doesn't want to wear AFOs ...". Studies show that children with CP often lose functional ability through adolescence and early adulthood, but it is not clear how that relates to their use or non-use of prescribed AFOs. There are also many factors which contribute to compliance with clinical recommendation and a scarcity of research into the psychological elements which can impact on this, though research indicates that perception and empowerment can increase the likelihood of a successful intervention application and compliance rates.

In this application the investigators seek to explore both the objective, functional benefits of using AFOs and the subjective experience of children and their families. A combination of quantitative and qualitative approaches will be used to understand the factors affecting children's compliance.

Purpose, aims or hypothesis

The overall aim is to understand the factors affecting compliance in children with cerebral palsy using AFOs. The investigators propose to do this by combining quantitative measurement of functional benefit, with qualitative exploration of the patient's experience.

To achieve this the investigators will:- Phase 1: Measure the functional effect of AFOs using 3D movement analysis technology in four children (treated as case studies).

Phase 2: Record patient compliance in the same group of children using sensors embedded in the AFOs Phase 3: Interview children and their families to explore the experience of using assistive devices.

Experimental plan, methods, timetable:

Children with cerebral palsy will be recruited from the routine clinics in ORLAU, at the RJAH Orthopaedic Hospital. The investigators will aim to recruit 4 children with cerebral palsy who have been prescribed bilateral moulded AFOs, two from primary school years 5/6 (1F, 1M) and two from secondary school years 7-9 (1F, 1M). The children will be GMFCS level 1 or 2 and be in main stream education.

Phase 1: 3D movement analysis

Children will be measured by means of 3D movement analysis (Vicon) at their supply appointment. Markers will be placed on the lower limbs and pelvis using the Plug-in-Gait model. Children will be measured walking in shoes with and without their AFOs. The gait analysis will provide detailed quantification of angles and moments at each joint, however the primary measures will be walking speed and the collated GPS which gives an overall score of the deviation from normal walking.

A full clinical examination will also be performed, along with video film of their feet when walking barefoot to assess the extent of any foot deformity.

Phase 2: Assessment of compliance

Each AFO will be fitted with an Orthotimer (www.orthotimer.com) sensor before it is supplied. This data will be downloaded at the review appointment, when the interviews will also be conducted. The device stores data every 15 min for up to 100 days recording whether the orthosis is in use at a given time.

Phase 3: Interviews

Semi-structured interviews will take place with the children recruited for phase 1, asking questions which will allow them to discuss their experiences of living with CP and of using assistive devices, particularly within their school environment; participants in secondary school will be also be asked about their experience in primary school. Questions will be as open as possible to allow the child to give rich, detailed accounts of their day to day experiences and their perceptions of AFOs. The interviews should provide a broad understanding of individual experiences and perspectives of AFOs and reasons for compliance. All children and their families will be invited back to verify the themes from the interviews at a separate, non-clinical, visit. Themes from the school group sessions will be used to shape the questions.

A mapping exercise, based on previous research will be used to enhance the discussion and visually identify locations where the children use their AFOs, their feelings triggered by a range of environments, and any issues they may have with the orthotic devices. These maps can then be used to facilitate further discussion about the children's experiences and analysed alongside the Orthotimer data to develop an in-depth view of the children's use and perception of their AFOs.

Study Type

Observational

Enrollment (Anticipated)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with cerebral palsy

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking speed (m/s)
Time Frame: At baseline
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
Time Frame: At baseline
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)
Time Frame: At end of 3 months of use
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
Time Frame: At end of 3 months of use
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Collaborators

University of Nottingham
Keele University

Investigators

  • Principal Investigator: Dr C Stewart, PhD, RJAH Orthopaedic Hospital/Keele University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 30, 2022

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

September 2, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (Actual)

September 9, 2019

Study Record Updates

Last Update Posted (Actual)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RL1796

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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