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Идёт набор NCT07121075

The Effects of a Dynamic Arm Support in Daily Life

— Наблюдательное Neuromuscular Disease Neuromuscular Disability Assistive Technology Activities of Daily Living

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dynamic arm support.
Кому может быть актуально
Состояния в реестре: Neuromuscular Disease, Neuromuscular Disability, Assistive Technology, Activities of Daily Living. Базовые параметры: от 16 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Effects of a Dynamic Arm Support in Daily Life. A Mixed Methods Study Including the Different Components of the ICF

Обзор

The goal of this mixed method study is to learn about how a dynamic arm support device (DAS) helps people with everyday activities. The study focuses on people with neuro(-muscular) conditions, age 16 and older. The research questions that are formulated, are: * How does a person experience their daily activities, with and without a DAS? * What are the contextual (external and personal) factors that influence the use of a DAS? Participants will take part in three testing sessions. In each session, they must complete a few questionnaires and participate in an interview. The first time, without DAS. In the second and third session, they will be using their DAS (resp. 3 to 4 weeks and 3 months). The data collection will be executed by phone, digital questionnaires and/or paper.

Подробное описание

Methodology:

The target group consist of people:

* with neurological of (neuro)muscular diseases * at the age of 16 years or older * who are using a dynamic arm support for at least one activity of daily life. This dynamic arm support is developed by Focal Meditech BV (balancer, Flowing, Dowing, Gowing 2 or Top Help)

Study design:

A convergent parallel mixed method study, consisting of a quantitative and a qualitative component will be executed.

Quantitative data will be collected trough various questionnaires and measurements, during three testing sessions. The goal is to include 50 participants (sample size). To make a comparison between daily life with and without a dynamic arm support, paired t-tests or the Wilcoxon signed-rank test will be performed. All tests are two-tailed, with the significance level set at p \< 0.05 and a Bonferonni correction. SPSS, version 27.0, will be used for this data analysis.

Qualitative data will be collected trough in-depth interviews. Participant will be recruited through purposive sampling. The number of included participants will be determined by data saturation. Next, data-analysis will be carried out according to a phenomenological hermeneutical method. Analysis will be conducted in NVivo V.12.

Вмешательства

  • Устройство Dynamic arm support
    The participant will receive a new dynamic arm support.

Первичные конечные точки

  • Canadian Occupational Performance Measure (COPM) [Срок оценки: Test moment 0: Assessment before delivery of dynamic arm support (DAS), Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery]
  • Psychosocial impact of assistive devices scale (PIADS) [Срок оценки: Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery]
Вторичные конечные точки (7)
  • Visual Analogue Scale (VAS) - pain [Срок оценки: Test moment 0: Assessment before delivery of dynamic arm support (DAS), Test moment1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery]
  • The Flow State Scale for Occupational Tasks (FSSOT) [Срок оценки: Test moment 0: Assessment before delivery of dynamic arm support (DAS), Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery]
  • Diary [Срок оценки: Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery]
  • Caregiver Assistive Technology Outcome Measure (CATOM) [Срок оценки: Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery]
  • In-depth interview [Срок оценки: Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery]
  • Visual Analogue Scale (VAS) - fatigue [Срок оценки: Test moment 0: Assessment before delivery of dynamic arm support (DAS), Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery]
  • Positive Health [Срок оценки: Test moment 0: Assessment before delivery of dynamic arm support (DAS), Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery]

Критерии участия

Критерии включения

  • Age: 16 and oler
  • Being able to understand and comprehend test instructions
  • Using a DAS from Focal Meditech (Balancer, Flowing, Dowing, Gowing 2 or Top Help)

Критерии исключения

/

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 1 центр
  • Focal Meditech BV (their clients in their home situation) — Tilburg

Публикации

  • Shank TM, Wee J, Ty J, Rahman T. Quantitative measures with WREX usage. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:1375-1380. doi: 10.1109/ICORR.2017.8009440. PMID 28814012
  • Cruz A, Callaway L, Randall M, Ryan M. Mobile arm supports in Duchenne muscular dystrophy: a pilot study of user experience and outcomes. Disabil Rehabil Assist Technol. 2021 Nov;16(8):880-889. doi: 10.1080/17483107.2020.1749892. Epub 2020 Apr 15. PMID 32293211
  • Coscia M, Cheung VC, Tropea P, Koenig A, Monaco V, Bennis C, Micera S, Bonato P. The effect of arm weight support on upper limb muscle synergies during reaching movements. J Neuroeng Rehabil. 2014 Mar 4;11:22. doi: 10.1186/1743-0003-11-22. PMID 24594139
  • Prange GB, Jannink MJ, Stienen AH, van der Kooij H, Ijzerman MJ, Hermens HJ. Influence of gravity compensation on muscle activation patterns during different temporal phases of arm movements of stroke patients. Neurorehabil Neural Repair. 2009 Jun;23(5):478-85. doi: 10.1177/1545968308328720. Epub 2009 Feb 3. PMID 19190089
  • van der Heide L, de Witte L. The perceived functional benefit of dynamic arm supports in daily life. J Rehabil Res Dev. 2016;53(6):1139-1150. doi: 10.1682/JRRD.2015.06.0099. PMID 28355038
  • Collins, K. M. (2010). Advanced sampling designs in mixed research. Sage handbook of mixed methods in social and behavioral research, 353-377. SAGE Publications, Inc., https://doi.org/10.4135/9781506335193
  • Essers JMN, Murgia A, Peters AA, Janssen MMHP, Meijer K. Recommendations for studies on dynamic arm support devices in people with neuromuscular disorders: a scoping review with expert-based discussion. Disabil Rehabil Assist Technol. 2022 Jul;17(5):487-500. doi: 10.1080/17483107.2020.1806937. Epub 2020 Sep 26. PMID 32981390
  • Essers J, Murgia A, Peters A, Meijer K. Daily Life Benefits and Usage Characteristics of Dynamic Arm Supports in Subjects with Neuromuscular Disorders. Sensors (Basel). 2020 Aug 28;20(17):4864. doi: 10.3390/s20174864. PMID 32872138

Идентификаторы

NCT: NCT07121075 · B1152024000010

Первоисточники (государственные реестры)

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