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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2028-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Inclusion Body Myositis Myotonic Dystrophy 1 Myotonic Dystrophy 2 Facio-Scapulo-Humeral Dystrophy Limb Girdle Muscular Dystrophies Pompe Disease (Infantile-Onset) Myasthaenia Gravis Lambert Eaton (LEMS) Spinal Muscular Atrophy (SMA) Guillain Barré Syndrome Chronic Inflammatory Demyelinating Polyneuropathy Friedreich Ataxia Hereditary Motor and Sensory Neuropathies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

A study protocol was developed with two cohorts that underwent a one-week pre-post intervention with gait assistive devices. The first group consisted of patients (n= 15) requiring orthopaedic support: Knee and/or ankle foot orthoses and orthopaedic shoes; the second group (n= 15) consists of patients requiring mobility aids: Forearm crutches, rollators and walking aids.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pre-intervention period

One week without therapy with asssisitive gait devices. During this week, patients undergoing inpatient rehabilitation receive standard therapy for neuromuscular disorders.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention period

One week therapy with assisitve gait devices.

Group Type EXPERIMENTAL

Assistive gait devices combined with physiotherapy

Intervention Type DEVICE

During the intervenation week, the patient undergoes 12 hours/week of gait training, fall prevention, balance group and physiotherapy as part of their inpatient rehabilitation programme. The individual sessions last 30 minutes each.

Interventions

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Assistive gait devices combined with physiotherapy

During the intervenation week, the patient undergoes 12 hours/week of gait training, fall prevention, balance group and physiotherapy as part of their inpatient rehabilitation programme. The individual sessions last 30 minutes each.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

65 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No