Clinical trials

Executing studies is of great importance to us and we are continuously working on our evidence strategy. All studies show positive effects of using Carbonhand. The result indicates improvement in grip strength.

Ongoing clinical trials

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.

Primary Objective:

• 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.

Secondary Objective(s):

• 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. Wiberg M. Effect of Rehabilitation, Difference in Hand Function, Activity and Participation by the Use of the Strengthening Glove Carbonhand for Patients with Plexus Brachial Injury: A pilot study

Published

1. 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

2. 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/10.1007/978

3. 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

4. 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

5. Hermansson L, Gunnarsson M, Lutterman M. Effect of a grip-strengthening glove on persons with reduced hand

function. (2014).

If you need more information or would like to suggest a study, please do not hesitate to contact Annika Rydgård who is responsible for our clinical trials. annika.rydgard@bioservo.com