NCT07072676

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: LMU Klinikum · Academic / Other
• Sex: All
• Age: 65 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• 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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-05-01
• Completion: 2028-08-01
• First posted: 2025-07-18
• Last updated: 2025-07-18

Locations

1 site across 1 country: Germany