Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03164031 |
| Other study ID # |
2016-7/HWB-HSC-14 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 10, 2018 |
| Est. completion date |
May 30, 2019 |
Study information
| Verified date |
October 2021 |
| Source |
Sheffield Hallam University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Walking can be slow and unsteady in people with multiple sclerosis (MS). This study will
investigate whether orthotic shorts might help.
Orthotic shorts are similar to the tight clothing believed to improve performance in
athletes. Research suggests that such shorts help stroke survivors to walk faster. Some
people with MS find that similar garments improve coordination and stability. Public funding
is controversial because there is no research investigating whether they work in people with
MS.
This is a cross-over study in which participants will each trial two different pairs of
shorts. The first aim is to determine whether these shorts are acceptable to people with MS.
Secondly, the study will develop the tools required to test the shorts. For example, by
determining which measures seem most appropriate and if specific factors predict whether the
shorts might help. The hypothesis being tested is that the shorts are acceptable.
People with MS will be invited to participate in this mixed methods study, aiming for a
sample size of 16 people. Participants will trial two different pairs of shorts, one of which
will fit more closely than the other. The shorts will be tested in a movement laboratory and
in daily life.
In the movement laboratory, participants will be measured in both pairs of shorts and in
normal, loose clothing. Walking pattern, speed and variability will be measured when the
shorts are first worn.
Participants will test shorts in their normal daily life for up to two weeks. They will
complete questionnaires about their walking and balance in the different shorts and record
how long they wear the shorts. Interviews will explore expectations and experiences of the
shorts and of the research study.
In the analyses, data from interviews will be combined with the numerical information gained
from laboratory measures, diaries and questionnaires. If the shorts are acceptable, this
study will inform a larger trial investigating effectiveness.
Description:
Study design - This is a mixed methods, randomised cross-over study investigating two
different pairs of orthotic shorts. The shorts will be tested in two main ways, firstly, the
impact of the shorts on objectively assessed walking ability when first worn and, secondly,
acceptability and impact of the shorts on self-perceived ability over a two-week period when
the shorts are worn in the community.
Participants - Participants will be people with multiple sclerosis (PwMS) who identify
themselves as having some difficulty walking, with a lack of stability around the hips and/or
lower trunk. The study aims to recruit 16 PwMS over a 15-16-month period. It is felt that a
sample size of 16 will enable the shorts to be trialled with participants with a range of
different movement problems as well as different ages, genders and activity levels. These
characteristics may impact upon the effect and acceptability of the shorts.
Recruitment - Participants will be made aware of the study through flyers, online
advertisements and in discussion with local healthcare professionals. Potential participants
will be identified through a local neurological therapy service.
Procedure - Each participant will visit Sheffield Hallam University on four occasions and be
seen at home on three occasions.
The first Sheffield Hallam visit (Appointment 1) will include informed consent, collection of
basic participant details, an initial interview around expectations and motivations,
completion of self-report measures, assessment and measurement for shorts with a
representative from the orthotics company and provision of a falls diary for completion over
the following two weeks. Participants will be randomly assigned to the order in which the
different shorts will be tested.
The second and third Sheffield Hallam visits (Appointments 3 and 5) follow the same structure
with each visit testing one of the two pairs of shorts. Firstly, walking ability without the
shorts will be measured. They will put the shorts on and spend about 30 minutes becoming
familiar with wearing the shorts before the objective measures are repeated. After the
objective assessments, participants will be provided with further information on wearing and
caring for the shorts and a wear diary and falls diary to be completed whilst the shorts are
trialed at home.
The final Sheffield Hallam visit (Appointment 7) will include a final measure of walking
ability without shorts plus a semi-structured interview around the participants' experiences
of the shorts and the trial.
In between the above visits to Sheffield Hallam, there will be three shorter visits. Each
participant can choose to attend university or meet in an agreed location if preferred. The
first of these (Appointment 2) will be with the representative from the orthotics company to
check the fit of the shorts and measure the pressure exerted by the shorts. If adjustments
are required at this point, this will be done within 3 days and the shorts will then be
delivered to the chief investigator. Appointments 4 and 6 are to collect the shorts, the
diaries and the self-report measures reporting the perceived impact of the shorts after the
period of home wear.
Intervention - The orthotic shorts will be custom-made by a UK based company that specialises
in dynamic, elastomeric orthoses for healthcare and sport. They will provide two pairs of
shorts for each participant, which will differ in the closeness of their fit. The company
representative, who will assess each participant, will decide the compression and fit of the
shorts, such as whether support for the lower trunk is required. The shorts can be
manufactured with a toileting hole, if preferred, allowing participants to toilet without
removing the shorts. Shorts with a toileting hole are usually worn beneath usual underwear.
Randomisation and allocation - Counter-balancing will ensure that half the group use the more
closely fitting shorts first and half the looser shorts first. A randomisation schedule will
be created by a using the Sealed Envelope online system for blocked randomisation. Shorts
will be placed into sealed envelopes labelled "Shorts 1" and "Shorts 2" by a third party
using the randomisation schedule.
Data collection - Semi-structured interviews will be conducted on two occasions for each
participant - at the first appointment and at the final appointment.
At Appointment 1, participants will be interviewed to explore their motivations for joining
the study, their expectations of the shorts, their current daily activities and their
readiness for change. The data from this interview will enable investigation of whether
certain aims, motivations or perceptions impact upon the eventual acceptability of the
shorts. This initial interview is likely to last 20 - 40 minutes.
At Appointment 7, participants will be interviewed about their experiences during the study.
This interview aims to determine the acceptability of the shorts and participants' views on
the study processes such as the information and support they received, and the outcome
measures used. Prior to the interview, the interviewer will review the data and reflective
notes from the initial interview; the wear diaries and the Participant Global Rating of
Change scores at the initial assessment and will use this information to inform the questions
that are asked. This will ensure the interviews are focussed on aspects that are important to
each participant. This final interview is likely to last 40 - 60 minutes.
Measures of walking ability - Outcome measures are described elsewhere and have been chosen
according to current guidelines on the most relevant assessment battery for walking in PwMS.
In addition to movement laboratory measures, participants will complete self-report
assessments of their walking and balance; a falls diary and a rating of the overall impact on
the shorts on their walking ability.
Data analysis - Qualitative and quantitative data will first be analysed separately and then
combined, partly by transforming qualitative into categorical data where this provides a
valid representation of the data and partly by comparing, contrasting and relating the
findings of the different data types for each objective.
Qualitative data analysis will use the Framework Approach to thematic analysis.
Descriptive quantitative data analysis will determine individual and average changes on each
measure and effect sizes for the impact of the shorts. Effect sizes will indicate which
measures are most responsive to this intervention and this information may be used to inform
a sample size calculation for future studies.
