The Effects of a Dynamic Arm Support in Daily Life

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorHasselt University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial population

The study population consists of individuals with a neuro(-muscular) or neurological condition who want to use a DAS, and who, after approval of a healthcare provider, also use a DAS.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Dynamic arm support

    Device

    The participant will receive a new dynamic arm support.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: People with neurological of (neuro)muscular diseases with a dynamic arm support1 intervention

Trial outcomes

Primary outcomes

1

Canadian Occupational Performance Measure (COPM)

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.

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
2

Psychosocial impact of assistive devices scale (PIADS)

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).

Time frame
Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery

Secondary outcomes

1

Visual Analogue Scale (VAS) - pain

The experienced pain, indicated on a VAS scale, between 0 and 10.

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
2

The Flow State Scale for Occupational Tasks (FSSOT)

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.

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
3

Diary

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).

Time frame
Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery
4

Caregiver Assistive Technology Outcome Measure (CATOM)

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.

Time frame
Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hasselt University

Lead sponsor

Focal Meditech BV

Collaborator