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

NCT07072676 | Enrolling By Invitation

• 1 other identifier: 25-0252
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

assistive gait device, neuromuscular diseases

Outcome Measures

Primary Outcomes (4)

• 6 Minute Walk Test

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

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

• Timed Up and Go (TUG)

  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.

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

• 10 meter walk test

  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.

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

• Dynamic Gait Index

  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.

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

Secondary Outcomes (1)

• The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)

  At the end of post-intervention period, Day 14.

Study Arms (2)

Pre-intervention period

NO INTERVENTION

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

Intervention period

EXPERIMENTAL

One week therapy with assisitve gait devices.

Device: Assistive gait devices combined with physiotherapy

Interventions

Assistive gait devices combined with physiotherapy 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.

Intervention period

Eligibility Criteria

• Age: 65 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• LMU Klinikum: lead

Study Sites (1)

Medical Park, Bad Feilnbach, Reithofpark

Bad Feilnbach, 53075, Germany

Location

Related Publications (6)

• Dias N, Kempen GI, Todd CJ, Beyer N, Freiberger E, Piot-Ziegler C, Yardley L, Hauer K. [The German version of the Falls Efficacy Scale-International Version (FES-I)]. Z Gerontol Geriatr. 2006 Aug;39(4):297-300. doi: 10.1007/s00391-006-0400-8. German.

  PMID: 16900450 BACKGROUND

• Waterval NFJ, Brehm MA, Altmann VC, Koopman FS, Den Boer JJ, Harlaar J, Nollet F. Stiffness-Optimized Ankle-Foot Orthoses Improve Walking Energy Cost Compared to Conventional Orthoses in Neuromuscular Disorders: A Prospective Uncontrolled Intervention Study. IEEE Trans Neural Syst Rehabil Eng. 2020 Oct;28(10):2296-2304. doi: 10.1109/TNSRE.2020.3018786. Epub 2020 Aug 24.

  PMID: 32833637 BACKGROUND

• Ounpuu S, Garibay E, Acsadi G, Brimacombe M, Pierz K. The impact of orthoses on gait in children with Charcot-Marie-Tooth disease. Gait Posture. 2021 Mar;85:198-204. doi: 10.1016/j.gaitpost.2021.02.005. Epub 2021 Feb 12.

  PMID: 33610823 BACKGROUND

• Mijic M, Wirner-Piotrowski C, Jung A, Gutschmidt K, Arndt M, Garcia-Angarita N, Wenninger S, Young P, Schoser B. The assistive gait devices and their implementation in activities of daily living for patients with neuromuscular disease: A systematic review and meta-analysis. J Neuromuscul Dis. 2026 Jan;13(1):53-76. doi: 10.1177/22143602241289216. Epub 2024 Dec 8.

  PMID: 39973408 BACKGROUND

• Dharmadasa T, Matamala JM, Huynh W, Zoing MC, Kiernan MC. Motor neurone disease. Handb Clin Neurol. 2018;159:345-357. doi: 10.1016/B978-0-444-63916-5.00022-7.

  PMID: 30482326 BACKGROUND

• Atalaia A, Thompson R, Corvo A, Carmody L, Piscia D, Matalonga L, Macaya A, Lochmuller A, Fontaine B, Zurek B, Hernandez-Ferrer C, Reinhard C, Gomez-Andres D, Desaphy JF, Schon K, Lohmann K, Jennings MJ, Synofzik M, Riess O, Yaou RB, Evangelista T, Ratnaike T, Bros-Facer V, Gumus G, Horvath R, Chinnery P, Laurie S, Graessner H, Robinson P, Lochmuller H, Beltran S, Bonne G. A guide to writing systematic reviews of rare disease treatments to generate FAIR-compliant datasets: building a Treatabolome. Orphanet J Rare Dis. 2020 Aug 12;15(1):206. doi: 10.1186/s13023-020-01493-7.

  PMID: 32787960 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Myositis, Inclusion Body; Myotonic Dystrophy; Muscular Dystrophy, Facioscapulohumeral; Muscular Dystrophies, Limb-Girdle; Glycogen Storage Disease Type II; Lambert-Eaton Myasthenic Syndrome; Muscular Atrophy, Spinal; Guillain-Barre Syndrome; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Friedreich Ataxia; Hereditary Sensory and Motor Neuropathy; Neuromuscular Diseases

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Myositis; Muscular Diseases; Musculoskeletal Diseases; Nervous System Diseases; Muscular Dystrophies; Muscular Disorders, Atrophic; Myotonic Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases, Nervous System; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Metabolism, Inborn Errors; Glycogen Storage Disease; Carbohydrate Metabolism, Inborn Errors; Lysosomal Storage Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Myasthenia Gravis; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Neuromuscular Junction Diseases; Autoimmune Diseases; Immune System Diseases; Spinal Cord Diseases; Motor Neuron Disease; Polyradiculoneuropathy; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Spinocerebellar Degenerations; Cerebellar Diseases; Mitochondrial Diseases; Nervous System Malformations; Congenital Abnormalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 18, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)