Neuromuscular DiseaseNCT07121075
The Effects of a Dynamic Arm Support in Daily Life
An observational study of Neuromuscular Disease and Neuromuscular Disability, run by Hasselt University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Neuromuscular Disease, Neuromuscular Disability, Assistive Technology
- What is being tested?
- Dynamic arm support
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Dec 2024to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- /
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Focal Meditech BV (their clients in their home situation)
Tilburg, 5026SP
Anoek Geers, +31 13 533 3103 ext. +31, A.Geers@focalmeditech.nl
About this study
Official title: The Effects of a Dynamic Arm Support in Daily Life. A Mixed Methods Study Including the Different Components of the ICF
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.
Read the 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.
- Conditions
- Neuromuscular Disease, Neuromuscular Disability, Assistive Technology, Activities of Daily Living, Occupational Therapy, Upper Limb
- Being tested
- Dynamic arm support
- Keywords
- dynamic arm support, dynamic arm support device, ICF, daily life, outcome measures
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic arm supportDevice
The participant will receive a new dynamic arm support.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Dynamic arm support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery
Secondary outcomes (7)
Visual Analogue Scale (VAS) - pain
The experienced pain, indicated on a VAS scale, between 0 and 10.
Measured: 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)
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.
Measured: 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
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).
Measured: Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery
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.
Measured: Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery
In-depth interview
An in-depth interview about:
- The personal motivation to use the dynamic arm support
- The external facilitators and barriers
Measured: Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery
Visual Analogue Scale (VAS) - fatigue
The experienced fatigue, indicated on a VAS scale. Scores between 0 and 10.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start2 Dec 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Focal Meditech BV
- Responsible party
- Principal investigator, Annemie Spooren, Hasselt University
- Investigators
- Joke Raats, Doctor, Principal investigator, UHasselt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121075
- Sponsor's protocol ID
- B1152024000010
- Status last verified
- Aug 2025
- First submitted
- 17 Feb 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: The data will be shared within the responsible investigators and researcher of UHasselt.
Publications
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.
PubMed 28814012Cruz 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.
PubMed 32293211Coscia 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.
PubMed 24594139Prange 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.
PubMed 19190089van 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.
PubMed 28355038Collins, 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
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.
PubMed 32981390Essers 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.
PubMed 32872138Lamers 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.
PubMed 25190063Michielsen 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.
PubMed 22465403
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Dynamic Arm Support in Daily Life. A Mixed Methods Study Including the Different Components of the ICF
- ClinicalTrials.gov ID
- NCT07121075
- Acronym / sponsor ID
- B1152024000010
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Focal Meditech BV
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with neurological of (neuro)muscular diseases with a dynamic arm support | – | Device: Dynamic arm supportThe cohort consist of individuals who apply for a dynamic arm support at Focal Meditech. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- /
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic arm supportThe participant will receive a new dynamic arm support. | Device | People with neurological of (neuro)muscular diseases with a dynamic arm support |
Primary outcome
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).
7 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Background: PubMed 28814012Shank 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.
- Background: PubMed 32293211Cruz 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.
- Background: PubMed 24594139Coscia 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.
- Background: PubMed 19190089Prange 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.
- Background: PubMed 28355038van 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.
- BackgroundCollins, 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: PubMed 32981390Essers 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.
- Background: PubMed 32872138Essers 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.
- Background: PubMed 25190063Lamers 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.
- Background: PubMed 22465403Michielsen 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.
- website of the different types of dynamic arm supports that are used in this studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. The data will be shared within the responsible investigators and researcher of UHasselt.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joke Raats, Doctor principal investigator
UHasselt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Disease and Neuromuscular Disability, run by Hasselt University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annemie Spooren, Professor Doctor (+3211 26 81 11 ext. +32, annemie.spooren@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07121075, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.