Trials / Recruiting
RecruitingNCT07121075
The Effects of a Dynamic Arm Support in Daily Life
The Effects of a Dynamic Arm Support in Daily Life. A Mixed Methods Study Including the Different Components of the ICF
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- Hasselt University · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- —
Summary
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.
Conditions
- Neuromuscular Disease
- Neuromuscular Disability
- Assistive Technology
- Activities of Daily Living
- Occupational Therapy
- Upper Limb
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dynamic arm support | The participant will receive a new dynamic arm support. |
Timeline
- Start date
- 2024-12-02
- Primary completion
- 2026-08-01
- Completion
- 2026-08-01
- First posted
- 2025-08-13
- Last updated
- 2025-08-13
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT07121075. Inclusion in this directory is not an endorsement.