Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2024-12-02
2026-08-31
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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People with neurological of (neuro)muscular diseases with a dynamic arm support
The cohort consist of individuals who apply for a dynamic arm support at Focal Meditech.
Dynamic arm support
The participant will receive a new dynamic arm support.
Interventions
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Dynamic arm support
The participant will receive a new dynamic arm support.
Eligibility Criteria
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Inclusion Criteria
* Being able to understand and comprehend test instructions
* Using a DAS from Focal Meditech (Balancer, Flowing, Dowing, Gowing 2 or Top Help)
Exclusion Criteria
16 Years
ALL
No
Sponsors
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Focal Meditech BV
UNKNOWN
Hasselt University
OTHER
Responsible Party
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Annemie Spooren
Professor Doctor
Principal Investigators
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Joke Raats, Doctor
Role: PRINCIPAL_INVESTIGATOR
UHasselt
Locations
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Focal Meditech BV (their clients in their home situation)
Tilburg, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Lamers I, Cattaneo D, Chen CC, Bertoni R, Van Wijmeersch B, Feys P. Associations of upper limb disability measures on different levels of the International Classification of Functioning, Disability and Health in people with multiple sclerosis. Phys Ther. 2015 Jan;95(1):65-75. doi: 10.2522/ptj.20130588. Epub 2014 Sep 4.
Michielsen ME, Selles RW, Stam HJ, Ribbers GM, Bussmann JB. Quantifying nonuse in chronic stroke patients: a study into paretic, nonparetic, and bimanual upper-limb use in daily life. Arch Phys Med Rehabil. 2012 Nov;93(11):1975-81. doi: 10.1016/j.apmr.2012.03.016. Epub 2012 Mar 28.
Related Links
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website of the different types of dynamic arm supports that are used in this study
Other Identifiers
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B1152024000010
Identifier Type: -
Identifier Source: org_study_id
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