Risk of fall
What it found
No result yet.
What was tested
Treatment tested
- Assistive gait devices combined with physiotherapy
What it measured
Main measures
6 Minute Walk Test
At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.
Walking and mobilityTimed Up and Go (TUG)
At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.
Walking and mobility10 meter walk test
At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.
Walking and mobilityDynamic Gait Index
At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.
Walking and mobility
Other measures (1)
The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
At the end of post-intervention period, Day 14.
Quality of life (reported by participants)
Who could take part
NMOSD · 65 to 65
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
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.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.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.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.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 syste
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History
Started
Sept 2025
Main results due
May 2027
Finished
Aug 2028
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