Feasibility and Acceptability of Orthotic Shorts for People With Multi

A Clinical Trial Evaluating the Feasibility and Acceptability of Orthotic Shorts for Walking Function in People With Multiple Sclerosis.

CompletedNot a drug-phase studyRelapsing and progressiveNCT03164031

What it found

No results found

We found no results in the registry or in papers.

This trial finished 7 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Close-fitting orthotic shorts

Compared with

  • Looser fitting shorts

What it measured

Main measures

  • Adherence to wear protocol

    After two weeks of shorts wear

    Quality of life (reported by participants)

Other measures (14)

  • Cadence

    At baseline and on Day 1 of shorts wear

    Walking and mobility

  • Step length

    At baseline and on Day 1 of shorts wear

    Walking and mobility

  • Proportion of gait cycle in double support

    At baseline and on Day 1 of shorts wear

    Walking and mobility

  • Width of base of support

    At baseline and on Day 1 of shorts wear

    Walking and mobility

  • Variability of step length

    At baseline and on Day 1 of shorts wear

    Walking and mobility

  • Variability of stride time

    At baseline and on Day 1 of shorts wear

    Walking and mobility

  • Variability of stride width

    At baseline and on Day 1 of shorts wear

    Walking and mobility

  • Trunk stability in walking

    At baseline and on Day 1 of shorts wear

    Walking and mobility

  • Walking speed

    At baseline and on Day 1 of shorts wear

    Disability progressionWalking and mobility

  • Cognitive demand of walking

    At baseline and on Day 1 of shorts wear

    Disability progressionThinking and memoryWalking and mobility

Who could take part

Relapsing and progressive · 18 and over

Show the full criteria

Inclusion criteria

* 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.

Exclusion criteria

* People who do not meet inclusion criteria. * 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Jan 2018

    2. Main results due

      May 2019

    3. Finished

      May 2019

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