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NCT Number: NCT07121075

The Effects of a Dynamic Arm Support in Daily Life

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.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Focal Meditech BV (their clients in their home situation)

Tilburg, 5026SP, Netherlands

Location status: Recruiting

Location contact

Anoek Geers

CONTACT

[email protected]

+31 13 533 3103 ext. +31

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

/

Treatment and study plan

Dynamic arm support

Device

The participant will receive a new dynamic arm support.

Primary outcomes

  1. Canadian Occupational Performance Measure (COPM)

    Time frame: 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.

  2. Psychosocial impact of assistive devices scale (PIADS)

    Time frame: 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 outcomes

  1. Visual Analogue Scale (VAS) - pain

    Time frame: 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.

  2. The Flow State Scale for Occupational Tasks (FSSOT)

    Time frame: 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.

  3. Diary

    Time frame: 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).

  4. Caregiver Assistive Technology Outcome Measure (CATOM)

    Time frame: 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.

  5. In-depth interview

    Time frame: 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

  6. Visual Analogue Scale (VAS) - fatigue

    Time frame: 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.

  7. Positive Health

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Annemie Spooren, Professor Doctor

CONTACT

[email protected]

+3211 26 81 11 ext. +32

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Focal Meditech BV

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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