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Clinical Trials/NCT04522349
NCT04522349
Completed
Not Applicable

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

Otto Bock France SNC1 site in 1 country8 target enrollmentSeptember 29, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transradial Amputation
Sponsor
Otto Bock France SNC
Enrollment
8
Locations
1
Primary Endpoint
Average shoulder abduction measure
Status
Completed
Last Updated
5 years ago

Overview

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
September 29, 2016
End Date
February 14, 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Otto Bock France SNC
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Average shoulder abduction measure

Time Frame: One minute

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

Secondary Outcomes

  • Manual dexterity(One minute)
  • User satisfaction(15 minutes)
  • Percentage of time spent with shoulder abduction more or equal to 60°(One minute)

Study Sites (1)

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