--- title: The Effects of a Dynamic Arm Support in Daily Life nct_id: NCT07121075 overall_status: RECRUITING sponsor: Hasselt University study_type: OBSERVATIONAL primary_condition: Neuromuscular Disease countries: Netherlands canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07121075.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07121075" ct_last_update_post_date: 2025-08-13 last_seen_at: "2026-05-12T07:14:47.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # The Effects of a Dynamic Arm Support in Daily Life **Official Title:** The Effects of a Dynamic Arm Support in Daily Life. A Mixed Methods Study Including the Different Components of the ICF **NCT ID:** [NCT07121075](https://clinicaltrials.gov/study/NCT07121075) ## Key Facts - **Status:** RECRUITING - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 50 - **Lead Sponsor:** Hasselt University - **Collaborators:** Focal Meditech BV - **Conditions:** Neuromuscular Disease, Neuromuscular Disability, Assistive Technology, Activities of Daily Living, Occupational Therapy, Upper Limb - **Start Date:** 2024-12-02 - **Completion Date:** 2026-08 - **CT.gov Last Update:** 2025-08-13 ## 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. ## Eligibility - **Minimum age:** 16 Years - **Sex:** ALL ``` 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: / ``` ## Arms - **People with neurological of (neuro)muscular diseases with a dynamic arm support** — The cohort consist of individuals who apply for a dynamic arm support at Focal Meditech. ## Interventions - **Dynamic arm support** (DEVICE) — The participant will receive a new dynamic arm support. ## Primary Outcomes - **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. - **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 - **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 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)_ - **Diary** _(time frame: Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery)_ - **Caregiver Assistive Technology Outcome Measure (CATOM)** _(time frame: Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery)_ - **In-depth interview** _(time frame: Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery)_ - **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)_ - **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)_ ## Locations (1) - Focal Meditech BV (their clients in their home situation), Tilburg, Netherlands — _RECRUITING_ ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.focal meditech bv (their clients in their home situation)|tilburg||netherlands` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT07121075.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT07121075* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*