Compensatory Movements With Axon-Hook and Greifer in Transradial Amputees

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Transradial Amputation

Intervention / Treatment
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* Device: Greifer then Axon-Hook
* Device: Axon-Hook then Greifer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: randomized crossover trial (AB/BA)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Greifer then Axon-Hook<br>T0 + 2 weeks: evaluation with Greifer. T1 + 2 weeks: evaluation with Axon-Hook | Device: Greifer then Axon-Hook<br>* 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.<br>|
| Active Comparator: Axon-Hook then Greifer<br>T0 + 2 weeks: evaluation with Axon-Hook. T1 + 2 weeks: evaluation with Greifer | Device: Axon-Hook then Greifer<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average shoulder abduction measure | Average measure of shoulder abuction during Box and Blocks manual dexterity test, by motion analysis | One minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Manual dexterity | Score at the Box and Blocks test | One minute | 
| User satisfaction | Score at the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder compensatory movements, myoelectric hooks, manual dexterity, satisfaction, Axon-Hook, Greifer