Feasibility and Acceptability of Orthotic Shorts for People With Multiple Sclerosis

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.

Conditions

• Multiple Sclerosis

Interventions

DEVICE

Close-fitting orthotic shorts

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.

DEVICE

Looser fitting shorts

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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust

  collaborator OTHER

• Sheffield Hallam University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-10

Primary Completion

2019-05-30

Completion

2019-05-30

Countries

• United Kingdom

Study Locations