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临床试验/NCT07072676
NCT07072676Enrolling By Invitation不适用

The Use of Assistive Gait Devices Can Reduce the Risk of Falls in Patients With Neuromuscular Diseases Following a Training Period.

LMU Klinikum2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
2
主要终点
6 Minute Walk Test

研究概览

简要总结

The planned project is an intervention study to assess the risk of falling after adaptation of an assistive gait devices in patients with the following neuromuscular diseases: Inclusion body myositis, myotonic dystrophy, limb girdle and facioscapulohumeral muscular dystrophies, Pompe disease, Lambert-Eaton syndrome, myasthenia gravis, spinal muscular atrophy, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, Friedreich's ataxia and hereditary motor and sensory neuropathy.

The primary aim is to assess the risk of falling after a suitable assistive gait device has been provided with an adaptation phase through training. The data should help to improve the provision of aids for patients with neuromuscular diseases. This should have a positive effect on the risk of falling and thus improve quality of life and reduce mortality and morbidity. To achieve these goals, a one-week intervention with training sessions on handling, balance and coordination as well as fall prevention will becarried out after the patient has been fitted with a suitable assistive gait device.

The interventions will be embedded in the inpatient rehabilitation programme. The functional gait and balance tests 'Timed Up and Go', '10 metre walk test', '6-minute walk test' and 'Dynamic Gait Index' will be recorded additionally.

The Falls Efficacy Scale International questionnaire will be utilised to evaluate the risk of falling, while the Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire will be employed to ascertain satisfaction with the assistive devices. The study is scheduled to run for a period of 14 days, during which participants will undergo three functional walking and balance tests. As part of the inpatient rehabilitation programme, participants will undergo a week-long period of rehabilitation without assistive technology, followed by a subsequent week of rehabilitation with adapted assistive technology.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 65 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • The Patients with sufficient cognitive and communicative abilities,
  • The Patients with confirmed by the genetic report and/or the final clinical diagnosis.

排除标准

  • The Patients scored more than 23 points on the falls efficacy Scale-International
  • The Patients are unable to walk at least ten metres without assistance,
  • The patient had knee, hip or back surgery in the last three months.
  • Patients suffering from polyneuropathy without a diagnosis of inflammatory autoimmune neuropathy.

结局指标

主要结局

6 Minute Walk Test

时间窗: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.

The aim of this test is to walk as far as possible for 6 minutes.

Timed Up and Go (TUG)

时间窗: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.

The TUG test measures the time it takes to stand up from a chair, walk three metres, turn around and sit back down on the same chair.

10 meter walk test

时间窗: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.

Walking at maximum speed is measured in a long, flat-surface corridor of 10 meters, with a standing start and a "flying" finish 2.5 meters beyond the 10-meter mark.

Dynamic Gait Index

时间窗: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.

Dynamic Gait Index tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It is a useful test in individuals with vestibular and balance problems and those at risk of falls.

次要结局

  • The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)(At the end of post-intervention period, Day 14.)

研究者

发起方
LMU Klinikum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marko Mijic

Principal Investigator

LMU Klinikum

研究点 (2)

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