Compensatory Movements With Axon-Hook and Greifer in Transradial Amputees

NCT04522349 | Completed

• 2 other identifiers: 20PT003-FR-01-05162016-A00897-44
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transradial Amputation

Keywords

shoulder compensatory movements; myoelectric hooks; manual dexterity; satisfaction; Axon-Hook; Greifer

Outcome Measures

Primary Outcomes (1)

• Average shoulder abduction measure

  Average measure of shoulder abuction during Box and Blocks manual dexterity test, by motion analysis

  One minute

Secondary Outcomes (3)

• Percentage of time spent with shoulder abduction more or equal to 60°

  One minute

• Manual dexterity

  One minute

• User satisfaction

  15 minutes

Study Arms (2)

Greifer then Axon-Hook

ACTIVE COMPARATOR

T0 + 2 weeks: evaluation with Greifer. T1 + 2 weeks: evaluation with Axon-Hook

Device: Greifer then Axon-Hook

Axon-Hook then Greifer

ACTIVE COMPARATOR

T0 + 2 weeks: evaluation with Axon-Hook. T1 + 2 weeks: evaluation with Greifer

Device: Axon-Hook then Greifer

Interventions

Greifer then Axon-Hook DEVICE

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.

Greifer then Axon-Hook

Axon-Hook then Greifer DEVICE

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.

Axon-Hook then Greifer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otto Bock France SNC: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Institut Régional de Rééducation et de Réadaptation

Nancy, Lorraine, 54000, France

Location

Related 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

  BACKGROUND

• 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.

  PMID: 25192744 BACKGROUND

• 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.

  PMID: 19367522 BACKGROUND

• 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.

  PMID: 22449551 BACKGROUND

• 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.

  PMID: 22133243 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 26979272 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 25356979 BACKGROUND

• 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.

  PMID: 25336050 BACKGROUND

• 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. doi: 10.5014/ajot.39.6.386.

  PMID: 3160243 BACKGROUND

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

  PMID: 18675497 BACKGROUND

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

  PMID: 20362374 BACKGROUND

• Loiret I, Paysant J, Martinet N, Andre JM. [Evaluation of amputees]. Ann Readapt Med Phys. 2005 Jul;48(6):307-16. doi: 10.1016/j.annrmp.2005.03.009. Epub 2005 Apr 15. French.

  PMID: 15932782 BACKGROUND

• 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. doi: 10.1080/10400435.1996.10132268.

  PMID: 10159726 BACKGROUND

• 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.

  PMID: 18303805 BACKGROUND

• Gouzien A, de Vignemont F, Touillet A, Martinet N, De Graaf J, Jarrasse 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.

  PMID: 28694439 BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Amélie TOUILLET

  Institut Régional de Rééducation et de Réadaptation de Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized crossover trial (AB/BA)

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: September 29, 2016
• Primary Completion: February 14, 2017
• Study Completion: February 14, 2017
• Last Updated: August 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)