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| ID | Type | Description | Link |
|---|---|---|---|
| 25-0252 | Registry Identifier | ETHICS COMMITTEE AT THE LMU MUNICH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) | The QUEST 2.0 evaluates a patient's satisfaction with various assistive technologies. | At the end of post-intervention period, Day 14. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Park, Bad Feilnbach, Reithofpark | Bad Feilnbach | 53075 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16900450 | 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. | |
| 32833637 | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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In accordance with the guidelines of the Ethics Committee.
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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.
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| 33610823 | 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. |
| 39973408 | 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 | 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 |
| 32787960 | 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. |
| ID | Term |
|---|---|
| D018979 | Myositis, Inclusion Body |
| D009223 | Myotonic Dystrophy |
| D020391 | Muscular Dystrophy, Facioscapulohumeral |
| D049288 | Muscular Dystrophies, Limb-Girdle |
| D006009 | Glycogen Storage Disease Type II |
| D015624 | Lambert-Eaton Myasthenic Syndrome |
| D009134 | Muscular Atrophy, Spinal |
| D020275 | Guillain-Barre Syndrome |
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| D005621 | Friedreich Ataxia |
| D015417 | Hereditary Sensory and Motor Neuropathy |
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009422 | Nervous System Diseases |
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D020967 | Myotonic Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020140 | Lysosomal Storage Diseases, Nervous System |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D008661 | Metabolism, Inborn Errors |
| D006008 | Glycogen Storage Disease |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D016464 | Lysosomal Storage Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009157 | Myasthenia Gravis |
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D020511 | Neuromuscular Junction Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013118 | Spinal Cord Diseases |
| D016472 | Motor Neuron Disease |
| D011129 | Polyradiculoneuropathy |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013132 | Spinocerebellar Degenerations |
| D002526 | Cerebellar Diseases |
| D028361 | Mitochondrial Diseases |
| D009421 | Nervous System Malformations |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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