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The Effects of a Dynamic Arm Support in Daily Life

H

Hasselt University

Status

Enrolling

Conditions

Occupational Therapy
Upper Limb
Neuromuscular Disability
Activities of Daily Living
Assistive Technology
Neuromuscular Disease

Treatments

Device: Dynamic arm support

Study type

Observational

Funder types

Other

Identifiers

NCT07121075
B1152024000010

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

/

Trial design

50 participants in 1 patient group

People with neurological of (neuro)muscular diseases with a dynamic arm support
Description:
The cohort consist of individuals who apply for a dynamic arm support at Focal Meditech.
Treatment:
Device: Dynamic arm support

Trial contacts and locations

1

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Central trial contact

Annemie Spooren, Professor Doctor

Data sourced from clinicaltrials.gov

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