The Effects of a Dynamic Arm Support in Daily Life

Recruiting

• Conditions: Neuromuscular Disease; Neuromuscular Disability; Assistive Technology; Activities of Daily Living; Occupational Therapy; Upper Limb

• Registration Number: NCT07121075
• Lead Sponsor: Hasselt University

Brief 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.

Study Timeline

• Study Start: 2024-12-02
• Study First Submitted: 2025-02-17
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Primary Completion: 2026-08
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure (COPM)	Test moment 0: Assessment before delivery of dynamic arm support (DAS), Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery	The COPM is a semi-structured interview, where the participants give at least 5 activities of daily life. They give a score of satisfaction and performance (between 1 and 10) on these 5 activities.
Psychosocial impact of assistive devices scale (PIADS)	Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery	The psychosocial impact of assistive devices scale is a 26-item, self-report questionnaire designed to assess the effects of an assistive device (the DAS) on functional independence, well-being, and quality of life. Scores on competence (between -3 and +3), adaptability (between -3 and +3) and self-esteem (between -3 and +3).

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) - pain	Test moment 0: Assessment before delivery of dynamic arm support (DAS), Test moment1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery	The experienced pain, indicated on a VAS scale, between 0 and 10.
The Flow State Scale for Occupational Tasks (FSSOT)	Test moment 0: Assessment before delivery of dynamic arm support (DAS), Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery	The Flow State Scale for Occupational Tasks measures flow experiences during an activity with or without a dynamic arm support (DAS). Scores between 0 and 98.
Diary	Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery	During a period of 24 hours, participants fill out a diary in which they indicate how often and for what purposes they use their dynamic arm support (DAS).
Caregiver Assistive Technology Outcome Measure (CATOM)	Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery	The caregiver Assistive Technology Outcome Measure measures the caregiver's perception of the impacts of dynamic arm support in his or her life.; Scores between 18 and 90.
In-depth interview	Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery	An in-depth interview about: * The personal motivation to use the dynamic arm support; * The external facilitators and barriers
Visual Analogue Scale (VAS) - fatigue	Test moment 0: Assessment before delivery of dynamic arm support (DAS), Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery	The experienced fatigue, indicated on a VAS scale. Scores between 0 and 10.
Positive Health	Test moment 0: Assessment before delivery of dynamic arm support (DAS), Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery	A questionnaire that assesses 6 dimensions: body functions, mental well-being, sense of meaning, quality of life, participation and daily functioning.; Scores between 0 and 10, on each dimension.

Trial Locations

Locations (1)

Focal Meditech BV (their clients in their home situation); 🇳🇱 Tilburg, Netherlands