Dynamic arm support to help people with neuromuscular conditions use their arms in daily life.
The Effects of a Dynamic Arm Support in Daily Life. A Mixed Methods Study Including the Different Components of the ICF
This project tests whether using a Focal Meditech dynamic arm support helps people aged 16 and older with neuromuscular conditions perform everyday activities more easily.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Hasselt University Academic / other |
| Locations | 1 site (Tilburg) |
| Trial ID | NCT07121075 on ClinicalTrials.gov |
What this trial studies
This mixed-methods study combines quantitative questionnaires and qualitative in-depth interviews to understand how a dynamic arm support (DAS) affects daily activity performance. Participants (target n=50) complete three sessions: baseline without a DAS, then after 3–4 weeks and after 3 months using their Focal Meditech device, with data collected by phone, digital or paper questionnaires and interviews. Quantitative changes will be analyzed with paired statistical tests and appropriate corrections, while interviews will be analyzed using a phenomenological hermeneutical method in NVivo. The study focuses on real-world use and contextual factors that influence DAS adoption and daily experience.
Who should consider this trial
Good fit: Ideal participants are people aged 16 or older with neurological or neuromuscular conditions who already use a qualifying Focal Meditech dynamic arm support for at least one daily activity and can follow test instructions.
Not a fit: People who do not use a Focal Meditech device, cannot follow instructions, or whose arm impairment is not helped by mechanical support are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, using a dynamic arm support could make everyday tasks easier and reduce arm effort for people with neuromuscular conditions.
How similar studies have performed: Prior small studies of dynamic arm supports have reported functional improvements, but long-term, real-world evidence and qualitative data on daily use remain limited.
Eligibility criteria
Show full inclusion / exclusion 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: /
Where this trial is running
Tilburg
- Focal Meditech BV (their clients in their home situation) — Tilburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: Joke Raats, Doctor — UHasselt
- Study coordinator: Annemie Spooren, Professor Doctor
- Email: annemie.spooren@uhasselt.be
- Phone: +3211 26 81 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.