De kliniska bevisen
Att genomföra studier är av stor betydelse för oss som medicintekniskt företag och vi arbetar aktivt med att utveckla vår evidensstrategi. I samtliga av de genomförda kliniska studierna (med nära 200 deltagande användare) visas nyttan av användningen av Carbonhand. Studierna indikerar att användande av Carbonhand förbättrar såväl grepp- som nypstyrka och handfunktion.
Pågående kliniska studier:
1. Van der Sluis C.K, ten Hoff A, van Heijningen V, van der Esch, Stolwijk J, van den Broek, Rietman J.S. Therapeutic effect of prolonged use of a wearable soft-robotic glove during ADL on reduced hand function
A brief summary: A total number of 7 clinics in the Netherlands are involved in this study. The aim of the trial is to confirm the results from the different studies by an approved clinical trial that meets all existing and new regulation for clinical trials. The following are the objective:
Therapeutic effect of prolonged use of a wearable soft-robotic glove during activities of daily living (ADL) on reduced hand function.
Primärt effektmått:
• To examine whether prolonged use of the assistive Carbonhand© system during ADL at home results in a therapeutic effect in handgrip strength of the affected hand.
Sekundära effektmått:
• To examine whether prolonged use of the assistive Carbonhand© system during ADL at home results in a therapeutic effect in endurance of the affected hand.
• To examine whether prolonged use of the assistive Carbonhand© system during ADL at home results in improved functional performance of the affected hand.
• To examine the amount of use of the hand and Carbonhand© system during the intervention period.
• To examine whether prolonged use of the assistive Carbonhand© system during ADL at home results in an improved Quality of Life.
2. Helena Millkvist, Anna Källströmer, Birgitta Bernspang, Mikael Wiberg, Effects on participation, activity and hand function when using a grip enhancing device Carbonhand for patients with brachial plexus injury
Publicerade kliniska studier:
3. Susanne Palmcrantz, Jeanette Plantin, Jörgen Borg (2019) Factors affecting the usability of an assistive soft robotic glove after stroke or multiple sclerosis. J Rehabil Med 2020; 52: jrm00027
4. Radder B, Prange-Lasonder G.B, Kottink A, Holmberg J, Sletta K, van Dijk M et al. (2019) Home rehabilitation supported by a wearable soft-robotic device for improving hand function in older adults: A pilot randomized controlled trial. PLoS ONE 14(8): e0220544. doi.org/10.1371/journal.pone.0220544
5. Osuagwu B.A. et al. (2019) Clinical Trial of the Soft Extra Muscle Glove to Assess Orthotic and Long-Term Functional Gain Following Chronic Incomplete Tetraplegia: Preliminary Functional Results. In: Masia L., Micera S., Akay M., Pons J. (eds) Converging Clinical and Engineering Research on Neurorehabilitation III. ICNR 2018. Pp 385-389. doi.org/10.17/978-3-030-01845-0_77
6. Nilsson M, Fryxell W. A, Wadell C, von Holst H, Borg J. A Helping Hand –On Innovations for Rehabilitation and Assistive Technology. Grip strengthening glove to improve hand function in patients with neuromuscular disorders. Doctoral Thesis. Stockholm: Royal Institute of Technology; 2013. ISBN 978-91-7501-703-7
7. Hashida R, Matsuse H, Totsugi M, Omoto M, Shinozaki N, Tanaka J, Nago T. (2016). Study on the Effects of Motor-Assisted Gloves (SEM™ Glove) on Functional Disorders of the hand. www.kurume-u.ac.jp
8. Hermansson L, Gunnarsson M, Lutterman M. Effect of a grip-strengthening glove on persons with reduced hand function. (2014).
Om du behöver mer information eller vill föreslå en studie, tveka inte att kontakta Annika Rydgård som är ansvarig för kliniska studier. annika.rydgard@bioservo.com
*Global data, management compounded data, several sources. Reports like “Fit for Work Europe” – a study conducted by the Work Foundation across 23 European countries – musculoskeletal disorders (MSDs) reveal a growing need
**European Commission