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Recruiting NCT07121075

The Effects of a Dynamic Arm Support in Daily Life

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dynamic arm support.
Who it may be relevant to
Registry conditions: Neuromuscular Disease, Neuromuscular Disability, Assistive Technology, Activities of Daily Living. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Canadian Occupational Performance Measure (COPM) [Time frame: 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) [Time frame: Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery]
Secondary outcome measures (7)
  • Visual Analogue Scale (VAS) - pain [Time frame: 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) [Time frame: 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 [Time frame: Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery]
  • Caregiver Assistive Technology Outcome Measure (CATOM) [Time frame: Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery]
  • In-depth interview [Time frame: Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery]
  • Visual Analogue Scale (VAS) - fatigue [Time frame: 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 [Time frame: 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]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

/

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

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Focal Meditech BV (their clients in their home situation) — Tilburg

Publications

  • 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

Identifiers

NCT: NCT07121075 · B1152024000010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗