Feasibility and Acceptability of Orthotic Shorts for People With Multiple Sclerosis
A Clinical Trial Evaluating the Feasibility and Acceptability of Orthotic Shorts for Walking Function in People With Multiple Sclerosis.
1 other identifier
interventional
16
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable multiple-sclerosis
Started Jan 2018
1 active site
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
April 11, 2017
CompletedFirst Posted
Study publicly available on registry
May 23, 2017
CompletedStudy Start
First participant enrolled
January 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2019
CompletedOctober 4, 2021
October 1, 2021
1.4 years
April 11, 2017
October 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Adherence to wear protocol
Adherence will be calculated as hours worn as a percentage of hours of wear requested.
After two weeks of shorts wear
Secondary Outcomes (14)
Cadence
At baseline and on Day 1 of shorts wear
Step length
At baseline and on Day 1 of shorts wear
Proportion of gait cycle in double support
At baseline and on Day 1 of shorts wear
Width of base of support
At baseline and on Day 1 of shorts wear
Variability of step length
At baseline and on Day 1 of shorts wear
- +9 more secondary outcomes
Study Arms (2)
Close-fitting orthotic shorts condition
EXPERIMENTALOrthotic shorts will be made to measure for each participant, designed to provide some compression to the hips, pelvis and thighs and to provide support. Shorts will be worn during objective testing of walking ability and then taken home. Wear will be increased gradually over 5 days but then worn every day during normal daily activity.
Looser fitting shorts condition
ACTIVE COMPARATORLooser shorts will be made to measure for each participant, designed to look similar to the orthotic shorts but provide minimal support or compression. Shorts will be worn during objective testing of walking ability and then taken home. Wear will be increased gradually over 5 days but then worn every day during normal daily activity.
Interventions
The orthotic shorts will be custom-made by DM Orthotics, a UK based company that specialises in dynamic, elastomeric orthoses for healthcare and sport. They will provide both pairs of shorts for each participant, both constructed from a 275 g/m2 fabric, which is 51% Polyamide, 32% Dorlastan and 17% cotton. A company representative will assess each participant to 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 worn beneath usual underwear.
Looser fitting shorts will be custom-made by DM Orthotics, a UK based company that specialises in dynamic, elastomeric orthoses for healthcare and sport. Shorts will be constructed from a 275 g/m2 fabric, which is 51% Polyamide, 32% Dorlastan and 17% cotton. A company representative will assess each participant to decide the fit of the shorts. 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 worn beneath usual underwear.
Eligibility Criteria
You may qualify if:
- Diagnosed as having multiple sclerosis of any type (relapsing-remitting, primary progressive or secondary progressive).
- Clinically stable - have not experienced relapse in the last 4 weeks; have not commenced a novel therapy in the last 3 months.
- Able to travel to Sheffield Hallam University for assessments.
- Have difficulty walking with a subjective feeling of instability around the hips or lower trunk.
- Able to walk for at least 2 minutes at a time.
- Able to provide a written record of informed consent.
You may not qualify if:
- Skin conditions that may be exacerbated by tight clothing.
- Circulatory problems that may be exacerbated by tight clothing, such as varicose veins, previous thrombosis, venous or arterial insufficiency.
- Cognitive problems including memory disturbance that may impact on recall of experience and adherence to guidance.
- Pregnancy - because of related circulatory problems.
- Living further than 10 miles from Sheffield if they are unable to provide own transport and the home visits would be too far for the researcher to travel.
- Have previously used orthotic shorts.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S10 2JF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants will be trialling two different pairs of shorts, where one pair will be designed as an orthoses and the other will look similar but be looser and not designed to support the hips. The investigator is also the main outcome assessor and they will be blinded to which pair of shorts will be worn at each stage of the study.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2017
First Posted
May 23, 2017
Study Start
January 10, 2018
Primary Completion
May 30, 2019
Study Completion
May 30, 2019
Last Updated
October 4, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- All anonymised data will be archived into the Sheffield Hallam University Research Data Archive in September 2019 at which point it will be openly available. This will not include interview recordings or transcripts because of the risk of participants being identied from this data.
- Access Criteria
- Data will be available as Open Access.
Following study completion, anonymised data on walking ability with and without orthotic shorts will be made available via the Sheffield Hallam University Research Data Archive.