Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People suffering from a neuromuscular disease, such as polio, or a disease of the central nervous system, often have a problem called knee instability. Knee instability is caused by weakness in the muscles of the knee. This can result in difficulties in walking and can lead to falls as the knee gives way during activities. Orthotic devices, otherwise known as braces or callipers, are used to support and give strength to the knee and also hold the leg in position. To date, there has not been any research on what types of orthotic devices are most commonly used by the NHS, how much they cost and how well they work. There is some evidence to suggest that people don’t use their orthotic devices as they should, so it’s important to understand patients perceptions of how these devices affect their physical, psychological and social wellbeing, whether they are satisfied with the treatment and to learn more about their views of different aspects of their treatment. Here, we want to carry out an interview study, talking to people in both a one-to-one setting and in focus groups about their experiences using their orthotic device.

Who can participate?
People aged at least 16 with a neuromuscular disorder and whose walking has been affected by instability of the knee.

What does the study involve?
Participants are invited to take part in a one-to-one interview with a researcher, or in a focus group discussion. The interviews focus on the participants experiences of their orthotic device, how it affects their everyday life and what they hope they will get from the treatment. They are encouraged to share their views with others during the focus group discussions. The sessions last for about an hour and a half and are recorded on a digital audio recorder. Everything discussed is confidential.

What are the possible benefits and risks of participating?
Participants do not benefit directly from taking part in the study. However, they will be helping to better understand how to improve treatment for people with neuromuscular disease and knee stability and improve future research. It is very unlikely that any harm should come to participants as a result of taking part in this study. However, if they do have any concerns about the way they have been approached or treated during this study, they will be advised to contact the Chief Investigator for the overall study.

Where is the study run from
The research is being undertaken by researchers based at the University of York. We will be recruiting patients to the study from St George’s Healthcare NHS Trust, Royal Derby Hospitals NHS Foundation Trust and Leeds Teaching Hospitals NHS Trust.

When is the study starting and how long is it expected to run for?
September 2014 to March 2015

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Catriona McDaid

Trial website

Contact information



Primary contact

Dr Catriona McDaid


Contact details

York Trials Unit
YO10 5DD
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Orthotic management of the knee in neuromuscular and central nervous system conditions



Study hypothesis

What are the important physical and psycho-social treatment outcomes for people who have been fitted with an orthotic device for knee instability.

Ethics approval

14/LO/1132; First MREC approval date 18/06/2014

Study design

Non-randomised; Observational; Design type: Qualitative

Primary study design


Secondary study design


Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Musculoskeletal disorders, Neurological disorders; Subtopic: Musculoskeletal (all Subtopics), Neurological (all Subtopics); Disease: Musculoskeletal, Neuro-muscular and Encephalitis


Qualitative interview: Study participants will take part in a face-to-face interview with the researcher or participate in a focus group discussion.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Patient perspectives of experiences of orthoses; Timepoint(s): Participation in interview/focus group on one occasion

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Adults (16 years and older) with a neuromuscular disorder who have impaired walking ability due primarily to instability of the knee. Neuromuscular disorder will include conditions that primarily affect the peripheral nerve, muscle and neuromuscular junction e.g. motor neurone disease, muscular dystrophy, myasthenia gravis, spinal muscular atrophy, Charcot Marie Tooth disease, polio, myopathies, inclusion body myositis. People with knee instability related to CNS conditions will also be included e.g. spinal cord injury, spina bifida, stroke.
2. People who are able to give informed consent.
3. Purposive sampling will be used to select participants for interview to reflect a range of conditions, age, sex, length of
time fitted with an orthosis, high and low usage, living in different regions in England.

Participant type


Age group




Target number of participants

Planned Sample Size: 50; UK Sample Size: 50;

Participant exclusion criteria

1. People aged under 16 years.
2. People with neuromuscular disorders other than those listed in Inclusion criteria above.
3. People who are unable to give informed consent, due to cognitive impairment, or for other reasons.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

York Trials Unit, Heslington
YO10 5DD
United Kingdom

Sponsor information


University of York (UK)

Sponsor details

Department of Health Sciences
York Trials Unit
Area 4
Sebohm Rowntree Building
YO10 5DD
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research Health Technology Assessment; Grant Codes: 13/30/02 (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes