Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Focal Meditech BV | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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:
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.
Methodology:
The target group consist of people:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic arm support | Device | The participant will receive a new dynamic arm support. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) - pain | The experienced pain, indicated on a VAS scale, between 0 and 10. | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
/
Not provided
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annemie Spooren, Professor Doctor | Contact | +3211 26 81 11 | +32 | annemie.spooren@uhasselt.be |
| Name | Affiliation | Role |
|---|---|---|
| Joke Raats, Doctor | UHasselt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Focal Meditech BV (their clients in their home situation) | Recruiting | Tilburg | 5026SP | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28814012 | Background | 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. | |
| 32293211 | 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. |
| Label | URL |
|---|---|
| website of the different types of dynamic arm supports that are used in this study | View source |
Not provided
The data will be shared within the responsible investigators and researcher of UHasselt.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| 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). | 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. | Test moment 1: assessment 3 weeks after delivery, Test moment 2: assessment 3 months after delivery |
| In-depth interview | An in-depth interview about:
| 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. | 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. | 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 |
| 24594139 | 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. |
| 19190089 | 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. |
| 28355038 | 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. |
| 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 |
| 32981390 | 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. |
| 32872138 | 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. |
| 25190063 | 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. |
| 22465403 | 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. |