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

LMU Klinikum

Status: Invitation-only

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

Treatments: Device: Assistive gait devices combined with physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07072676

25-0252 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 65 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Pre-intervention period

No Intervention group

Description:

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

Intervention period

Experimental group

Description:

One week therapy with assisitve gait devices.

Treatment:

Device: Assistive gait devices combined with physiotherapy