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The Effects of a Dynamic Arm Support in Daily Life

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07121075
Enrollment
50
Registered
2025-08-13
Start date
2024-12-02
Completion date
2026-08-31
Last updated
2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

dynamic arm support, dynamic arm support device, ICF, daily life, outcome measures

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.

Interventions

DEVICEDynamic arm support

The participant will receive a new dynamic arm support.

Sponsors

Focal Meditech BV
CollaboratorUNKNOWN
Hasselt University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum

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

/

Design outcomes

Primary

MeasureTime frameDescription
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 deliveryThe 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 deliveryThe 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

MeasureTime frameDescription
DiaryTest moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after deliveryDuring 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 deliveryThe 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.
Visual Analogue Scale (VAS) - painTest moment 0: Assessment before delivery of dynamic arm support (DAS), Test moment1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after deliveryThe experienced pain, indicated on a VAS scale, between 0 and 10.
Visual Analogue Scale (VAS) - fatigueTest 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 deliveryThe experienced fatigue, indicated on a VAS scale. Scores between 0 and 10.
Positive HealthTest 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 deliveryA 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.
In-depth interviewTest moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after deliveryAn in-depth interview about: * The personal motivation to use the dynamic arm support * The external facilitators and barriers
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 deliveryThe 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.

Countries

Netherlands

Contacts

Primary ContactAnnemie Spooren, Professor Doctor
annemie.spooren@uhasselt.be+3211 26 81 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026