Actively Recruiting

Age: 16Years +
All Genders
ID07121075

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

Led by Hasselt University · Updated on 2025-08-13

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

H

Hasselt University

Lead Sponsor

F

Focal Meditech BV

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how a dynamic arm support device (DAS) affects daily activities for people aged 16 and older with neurological or neuromuscular conditions. The study aims to understand participants' experiences with and without the DAS and explore external and personal factors influencing its use. This mixed-method study combines quantitative questionnaires and qualitative interviews to capture a comprehensive picture of daily life impacts. Participants will engage in three testing sessions: the first session without using the DAS, and the second and third sessions after using the DAS for approximately 3 to 4 weeks and 3 months, respectively. The dynamic arm supports involved are developed by Focal Meditech and include models such as Balancer, Flowing, Dowing, Gowing 2, or Top Help. Data collection will be conducted via phone interviews, digital questionnaires, or paper forms. During the study, participants complete various questionnaires and in-depth interviews to assess occupational performance, psychosocial impact, pain, fatigue, flow state during tasks, and positive health. These assessments occur before receiving the DAS, then again at 3 weeks and 3 months after delivery. Researchers will analyze the results to compare life with and without the device, aiming to include about 50 participants in total.

CONDITIONS

Brief Title

The Effects of a Dynamic Arm Support in Daily Life

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 16 years or older
  • Able to understand and follow test instructions
  • Currently using a dynamic arm support from Focal Meditech (Balancer, Flowing, Dowing, Gowing 2, or Top Help)
Not Eligible

You will not qualify if you...

  • None specified in the available information; no exclusion criteria provided explicitly

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Initial delivery and device set-up period

Participants receive a new dynamic arm support device developed by Focal Meditech.

1 visit (in-person) at device delivery

Monitoring

Duration - 3 months

Participants complete questionnaires, measurements, and in-depth interviews to assess daily life with and without the dynamic arm support.

3 testing sessions: at device delivery, 3 weeks after delivery, and 3 months after delivery

Trial Site Locations

Total: 1 location

1

Focal Meditech BV (their clients in their home situation)

Tilburg, Netherlands, 5026SP

Actively Recruiting

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Research Team

A

Annemie Spooren, Professor Doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Influence of gravity compensation on muscle activation patterns during different temporal phases of arm movements of stroke patients.

G B Prange, M J A Jannink, A H A Stienen...

https://pubmed.ncbi.nlm.nih.gov/19190089

Recommendations for studies on dynamic arm support devices in people with neuromuscular disorders: a scoping review with expert-based discussion.

J M N Essers, A Murgia, A A Peters...

https://pubmed.ncbi.nlm.nih.gov/32981390

Daily Life Benefits and Usage Characteristics of Dynamic Arm Supports in Subjects with Neuromuscular Disorders.

Johannes Essers, Alessio Murgia, Anneliek Peters...

https://pubmed.ncbi.nlm.nih.gov/32872138

Associations of upper limb disability measures on different levels of the International Classification of Functioning, Disability and Health in people with multiple sclerosis.

Ilse Lamers, Davide Cattaneo, Christine C Chen...

https://pubmed.ncbi.nlm.nih.gov/25190063

Quantifying nonuse in chronic stroke patients: a study into paretic, nonparetic, and bimanual upper-limb use in daily life.

Marian E Michielsen, Ruud W Selles, Henk J Stam...

https://pubmed.ncbi.nlm.nih.gov/22465403