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 dont use their orthotic devices as they should, so its 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 Georges 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
catriona.mcdaid@york.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Catriona McDaid
ORCID ID
Contact details
York Trials Unit
Heslington
York
YO10 5DD
United Kingdom
-
catriona.mcdaid@york.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16978
Study information
Scientific title
Orthotic management of the knee in neuromuscular and central nervous system conditions
Acronym
OKIS
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
Observational
Secondary study design
Other
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Musculoskeletal disorders, Neurological disorders; Subtopic: Musculoskeletal (all Subtopics), Neurological (all Subtopics); Disease: Musculoskeletal, Neuro-muscular and Encephalitis
Intervention
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
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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
01/09/2014
Overall trial end date
31/03/2015
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
Both
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
01/09/2014
Recruitment end date
31/03/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
York Trials Unit, Heslington
York
YO10 5DD
United Kingdom
Funders
Funder type
Government
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
Location
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
Basic results (scientific)
Publication list
2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27477023