Exploring Muscle Structure, Function and Gait Patterns in People With Distal Hereditary Motor Neuropathy: Natural History and the Effect of Rehabilitation Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Muscle fat fraction
研究概览
简要总结
Distal Hereditary Motor Neuropathy (dHMN) is a rare inherited neuromuscular disorder. It is characterised by distal weakness. The condition usually manifests in the second decade of life and progresses slowly. Though patients usually have a normal lifespan it is a disabling condition and most eventually need aids to walk. In order to improve walking quality in patient with dHMN, research is needed to understand the impairments that lead to altered gait patterns, and to develop interventions to correct walking gait conservatively.
In this proposed trial our goal is to explore the relationships between muscle structure, function and gait patterns for people with Distal Hereditary Motor Neuropathy. Over 12 months, muscle changes in dHMN are going to be observed in terms of structure and function using MRI, myometry and 3D motion analysis. In addition, the effect of a 16 weeks exercises program on muscle structure and function in dHMN is going to be measured by the same observational methods. To address walking gait directly in dHMN, gait patterns with and without wearing carbon fibre ankle foot orthoses (AFO)will be measured using 3D motion analysis.
详细描述
Objectives: The primary objective (objective 1) is to:
- explore the natural history of muscle structure and function in Distal Hereditary Motor Neuropathy (dHMN) over one year.
The secondary objectives are: 2. to ascertain relationships between intramuscular fat fraction (measured by MRI), muscle volume, isokinetic muscle strength (measured by dynamometry) and moments/power generation (measured by 3D gait analysis) (objective 2). 3. to explore the effect of bilateral carbon fibre ankle foot orthoses (AFO) on the kinetics and kinematics of gait of people with DHMN (measured by 3D gait analysis) (objective 3). 4. to explore the effect of resistance training of the ankle muscles in people with ankle muscle strength over grade 4 MRC scale on muscle structure, function, and gait patterns (objective 4).
Type of trial: A prospective cohort study in adult patients with dHMN with a single UK site.
Trial design and methods: This study (participants with dHMN and control participants) is proposed to take place over 3 years in one site in the UK (NHNN). Participants with dHMN aged over 18 for potential enrolment in the study will be identified through existing inherited neuropathy cohort clinics at NHNN and healthy control participants will be invited. If they show interest in participating, they will be given the relevant Patient Information Sheets and Informed Consent Forms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Muscle fat fraction
时间窗: 16 weeks
Percentage fat fraction measured by the 3-point Dixon method
次要结局
- Isokinetic muscle function(16 weeks)
- 3D gait analysis(16 weeks)
研究者
Gita Ramdharry
Consultant Allied Health Professional
University College London Hospitals