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

Overview

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.

Interventions

• 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.

Primary outcome measures

• 6 Minute Walk Test [Time frame: 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) [Time frame: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.]
• 10 meter walk test [Time frame: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.]
• Dynamic Gait Index [Time frame: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.]

Secondary outcome measures (1)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Germany · 1 center

• Medical Park, Bad Feilnbach, Reithofpark — Bad Feilnbach

Publications

• 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
• 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
• 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
• 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
• Dharmadasa T, Matamala JM, Huynh W, Zoing MC, Kiernan MC. Chapter 22 - Motor neurone disease. In: Day BL, Lord SRBT-H of CN, editors. Balanc. Gait, Falls, vol. 159, Elsevier; 2018, p. 345-57. https://doi.org/https://doi.org/10.1016/B978-0-444-63916-5.00022-7
• 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 syste PMID 32787960

Identifiers

NCT: NCT07072676 · 25-0252 · 25-0252

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗