Compensatory Movements With Axon-Hook and Greifer in Transradial Amputees

Transradial Amputation Clinical Trial

Official title:

Randomized Crossover Trial Comparing Shoulder Abduction Movements, Manual Dexterity and Satisfaction of Transradial Amputees Using Axon-Hook and Greifer Myoelectric Hooks.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04522349
• Other study ID #: 20PT003-FR-01-0516
• Secondary ID: 2016-A00897-44
• Status: Completed
• Phase: N/A
• Start date: September 29, 2016
• Est. completion date: February 14, 2017

Study information

• Verified date: August 2020
• Source: Otto Bock France SNC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Upper limb amputees often report musculoskeletal pain due to exaggerated shoulder abduction movements. Previous studies on prosthetic hands showed that wrist orientation contributes to reduce shoulder compensatory movements. The hypothesis of this research is that prosthetic hooks may also provide better functional outcomes when offering wrist adjustments and a design that favors a good visualization of the grips. The objective of this study is to compare shoulder abduction, manual dexterity and satisfaction when using Axon-Hook and Greifer myoelectric hooks during repetitive tasks. Shoulder abduction and manual dexterity results are also compared with the sound side.

Description:

Depending on patient's expectations, different prosthetic solutions can be offered. If prosthetic hands, being at the same time functional and aesthetic solutions, are widely used, for some professional or leisure activities, myoelectric users will have a better functional response with a non-morphologic terminal device such as a hook.

Axon-hook and Greifer are two myoelectric hooks proposed by Otto Bock HealthCare. Greifer (Myobock system) has two movable strong hooks and a wrist that can be orientated medially or laterally. Axon-Hook (Axon-Bus system) has thin hooks for a good visualization of the grip, one being fixed for more precision, and a flexible wrist that can be orientated and locked in flexion and extension position.

Previous studies on myoelectric hands showed that functionalities of prosthetic components such as type of hand or type of wrist, have an influence on compensatory movements, which can explain musculoskeletal pains. The hypothesis of the study is that Axon-Hook may reduce shoulder abduction and improve patient satisfaction. No significant difference is expected regarding manual dexterity.

This randomized corossover trial compares shoulder abduction, manual dexterity and satisfaction while using Axon-Hook and Greifer. Shoulder abduction and manual dexterity results are also compared with the sound side.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 14, 2017
• Est. primary completion date: February 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• persons with trans-radial upper limb amputation

• persons whose amputation is acquired or congenital

• persons who regularily uses a myoelectric prosthesis and who controls it

• persons whose residual limb is stabilized, with a minimum time of six month since amputation

• persons whose profesional activity or life project justify or could justify the use of a myoelectric hook

• persons who gave their written consent to participate to the study

Exclusion Criteria:

• persons under 18 years of age

• pregnant woman

• persons unable to personnaly give their consent

• persons with psychic or linguistic inability to understand instructions for the test

• persons unavailable to comply with the entire study protocol

Related Conditions & MeSH terms

• Transradial Amputation

Intervention

Device:
• Greifer then Axon-Hook
Each participant is fitted with a Greifer and assessed after two weeks home-trial. Then he is fitted with Axon-Hook and assessed after two weeks home trial.
• Axon-Hook then Greifer
Each participant is fitted with a Axon-Hook and assessed after two weeks home-trial. Then he is fitted with Greifer and assessed after two weeks home trial.

Locations

Country	Name	City	State
France	Institut Régional de Rééducation et de Réadaptation	Nancy	Lorraine

Sponsors (2)

Lead Sponsor	Collaborator
Otto Bock France SNC	EURAXI Pharma

Country where clinical trial is conducted

France, 

References & Publications (17)

A.G. Cutti; I. Parel; M. Luchetti; E. Gruppioni; N. Rossi; G. Verni, The Psychosocial and Biomechanical Assessment of Amputees Fitted with Commercial Multi-grip Prosthetic Hands, in: Grasping the Future: Advances in Powered Upper Limb Prosthetics, BOLOGNA, VINCENZO PARENTI CASTELLI & MARCO TRONCOSSI, 2012, pp. 59 - 77

Bertels T, Schmalz T, Ludwigs E. Objectifying the functional advantages of prosthetic wrist flexion. J Prosthet Orthot. 2009;21(2):74-8.

Bouwsema H, van der Sluis CK, Bongers RM. Movement characteristics of upper extremity prostheses during basic goal-directed tasks. Clin Biomech (Bristol, Avon). 2010 Jul;25(6):523-9. doi: 10.1016/j.clinbiomech.2010.02.011. Epub 2010 Apr 1. — View Citation

Carey SL, Dubey RV, Bauer GS, Highsmith MJ. Kinematic comparison of myoelectric and body powered prostheses while performing common activities. Prosthet Orthot Int. 2009 Jun;33(2):179-86. doi: 10.1080/03093640802613229. — View Citation

Carey SL, Jason Highsmith M, Maitland ME, Dubey RV. Compensatory movements of transradial prosthesis users during common tasks. Clin Biomech (Bristol, Avon). 2008 Nov;23(9):1128-35. doi: 10.1016/j.clinbiomech.2008.05.008. — View Citation

Deijs M, Bongers RM, Ringeling-van Leusen ND, van der Sluis CK. Flexible and static wrist units in upper limb prosthesis users: functionality scores, user satisfaction and compensatory movements. J Neuroeng Rehabil. 2016 Mar 15;13:26. doi: 10.1186/s12984-016-0130-0. — View Citation

Demers L, Weiss-Lambrou R, Ska B. Development of the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST). Assist Technol. 1996;8(1):3-13. — View Citation

Gouzien A, de Vignemont F, Touillet A, Martinet N, De Graaf J, Jarrassé N, Roby-Brami A. Reachability and the sense of embodiment in amputees using prostheses. Sci Rep. 2017 Jul 10;7(1):4999. doi: 10.1038/s41598-017-05094-6. — View Citation

Haverkate L, Smit G, Plettenburg DH. Assessment of body-powered upper limb prostheses by able-bodied subjects, using the Box and Blocks Test and the Nine-Hole Peg Test. Prosthet Orthot Int. 2016 Feb;40(1):109-16. doi: 10.1177/0309364614554030. Epub 2014 Oct 21. — View Citation

Hebert JS, Lewicke J, Williams TR, Vette AH. Normative data for modified Box and Blocks test measuring upper-limb function via motion capture. J Rehabil Res Dev. 2014;51(6):918-32. doi: 10.1682/JRRD.2013.10.0228. — View Citation

Loiret I, Paysant J, Martinet N, André JM. [Evaluation of amputees]. Ann Readapt Med Phys. 2005 Jul;48(6):307-16. Epub 2005 Apr 15. Review. French. — View Citation

Major MJ, Stine RL, Heckathorne CW, Fatone S, Gard SA. Comparison of range-of-motion and variability in upper body movements between transradial prosthesis users and able-bodied controls when executing goal-oriented tasks. J Neuroeng Rehabil. 2014 Sep 6;11:132. doi: 10.1186/1743-0003-11-132. — View Citation

Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. — View Citation

Metzger AJ, Dromerick AW, Holley RJ, Lum PS. Characterization of compensatory trunk movements during prosthetic upper limb reaching tasks. Arch Phys Med Rehabil. 2012 Nov;93(11):2029-34. doi: 10.1016/j.apmr.2012.03.011. Epub 2012 Mar 23. — View Citation

Miller LA, Stubblefield KA, Lipschutz RD, Lock BA, Kuiken TA. Improved myoelectric prosthesis control using targeted reinnervation surgery: a case series. IEEE Trans Neural Syst Rehabil Eng. 2008 Feb;16(1):46-50. doi: 10.1109/TNSRE.2007.911817. — View Citation

Ostlie K, Franklin RJ, Skjeldal OH, Skrondal A, Magnus P. Musculoskeletal pain and overuse syndromes in adult acquired major upper-limb amputees. Arch Phys Med Rehabil. 2011 Dec;92(12):1967-1973.e1. doi: 10.1016/j.apmr.2011.06.026. — View Citation

Resnik L, Borgia M, reliability and validity of outcome measures for upper limb amputation. JPO. 2012;24:192-201

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average shoulder abduction measure	Average measure of shoulder abuction during Box and Blocks manual dexterity test, by motion analysis	One minute
Secondary	Percentage of time spent with shoulder abduction more or equal to 60°	Percentage of time spent with shoulder abduction more or equal to 60° during Box and Blocks test	One minute
Secondary	Manual dexterity	Score at the Box and Blocks test	One minute
Secondary	User satisfaction	Score at the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)	15 minutes