A Clinical Trial Evaluating the Feasibility and Acceptability of Orthotic Shorts for Walking Function in People With Multiple Sclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Adherence to wear protocol
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Adherence to wear protocol
时间窗: After two weeks of shorts wear
Adherence will be calculated as hours worn as a percentage of hours of wear requested.
次要结局
- Balance confidence(At baseline and after two weeks of shorts wear)
- Walking speed(At baseline and on Day 1 of shorts wear)
- Variability of 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)
- Variability of stride time(At baseline and on Day 1 of shorts wear)
- Self-perceived walking ability(At baseline and after two weeks of shorts wear)
- Step length(At baseline and on Day 1 of shorts wear)
- Width of base of support(At baseline and on Day 1 of shorts wear)
- Trunk stability in walking(At baseline and on Day 1 of shorts wear)
- Participant rated perception of effect(On Day 1 of shorts wear)
- Cadence(At baseline and on Day 1 of shorts wear)
- Variability of stride width(At baseline and on Day 1 of shorts wear)
- Cognitive demand of walking(At baseline and on Day 1 of shorts wear)
- Frequency of falls(At baseline and after two weeks of shorts wear)