The Effects of a Dynamic Arm Support in Daily Life

NCT07121075 | Recruiting

• 1 other identifier: B1152024000010
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

• 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).

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

Secondary Outcomes (7)

• 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 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

• Diary

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

• Caregiver Assistive Technology Outcome Measure (CATOM)

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

• In-depth interview

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

Study Arms (1)

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.

Device: Dynamic arm support

Interventions

Dynamic arm support DEVICE

The participant will receive a new dynamic arm support.

People with neurological of (neuro)muscular diseases with a dynamic arm support

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

Sponsors & Collaborators

• Hasselt University: lead
• Focal Meditech BV: collaborator

Study Sites (1)

Focal Meditech BV (their clients in their home situation)

Tilburg, 5026SP, Netherlands

RECRUITING

Related Publications (10)

• Shank TM, Wee J, Ty J, Rahman T. Quantitative measures with WREX usage. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:1375-1380. doi: 10.1109/ICORR.2017.8009440.

  PMID: 28814012 BACKGROUND

• Cruz A, Callaway L, Randall M, Ryan M. Mobile arm supports in Duchenne muscular dystrophy: a pilot study of user experience and outcomes. Disabil Rehabil Assist Technol. 2021 Nov;16(8):880-889. doi: 10.1080/17483107.2020.1749892. Epub 2020 Apr 15.

  PMID: 32293211 BACKGROUND

• Coscia M, Cheung VC, Tropea P, Koenig A, Monaco V, Bennis C, Micera S, Bonato P. The effect of arm weight support on upper limb muscle synergies during reaching movements. J Neuroeng Rehabil. 2014 Mar 4;11:22. doi: 10.1186/1743-0003-11-22.

  PMID: 24594139 BACKGROUND

• Prange GB, Jannink MJ, Stienen AH, van der Kooij H, Ijzerman MJ, Hermens HJ. Influence of gravity compensation on muscle activation patterns during different temporal phases of arm movements of stroke patients. Neurorehabil Neural Repair. 2009 Jun;23(5):478-85. doi: 10.1177/1545968308328720. Epub 2009 Feb 3.

  PMID: 19190089 BACKGROUND

• van der Heide L, de Witte L. The perceived functional benefit of dynamic arm supports in daily life. J Rehabil Res Dev. 2016;53(6):1139-1150. doi: 10.1682/JRRD.2015.06.0099.

  PMID: 28355038 BACKGROUND

• Collins, K. M. (2010). Advanced sampling designs in mixed research. Sage handbook of mixed methods in social and behavioral research, 353-377. SAGE Publications, Inc., https://doi.org/10.4135/9781506335193

  BACKGROUND

• Essers JMN, Murgia A, Peters AA, Janssen MMHP, Meijer K. Recommendations for studies on dynamic arm support devices in people with neuromuscular disorders: a scoping review with expert-based discussion. Disabil Rehabil Assist Technol. 2022 Jul;17(5):487-500. doi: 10.1080/17483107.2020.1806937. Epub 2020 Sep 26.

  PMID: 32981390 BACKGROUND

• Essers J, Murgia A, Peters A, Meijer K. Daily Life Benefits and Usage Characteristics of Dynamic Arm Supports in Subjects with Neuromuscular Disorders. Sensors (Basel). 2020 Aug 28;20(17):4864. doi: 10.3390/s20174864.

  PMID: 32872138 BACKGROUND

• Lamers I, Cattaneo D, Chen CC, Bertoni R, Van Wijmeersch B, Feys P. Associations of upper limb disability measures on different levels of the International Classification of Functioning, Disability and Health in people with multiple sclerosis. Phys Ther. 2015 Jan;95(1):65-75. doi: 10.2522/ptj.20130588. Epub 2014 Sep 4.

  PMID: 25190063 BACKGROUND

• Michielsen ME, Selles RW, Stam HJ, Ribbers GM, Bussmann JB. Quantifying nonuse in chronic stroke patients: a study into paretic, nonparetic, and bimanual upper-limb use in daily life. Arch Phys Med Rehabil. 2012 Nov;93(11):1975-81. doi: 10.1016/j.apmr.2012.03.016. Epub 2012 Mar 28.

  PMID: 22465403 BACKGROUND

Related Links

• website of the different types of dynamic arm supports that are used in this study

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Joke Raats, Doctor

  UHasselt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annemie Spooren, Professor Doctor

CONTACT

+3211 26 81 11; annemie.spooren@uhasselt.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: August 13, 2025
• Study Start: December 2, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)