Clinical trial NCT04522349: Compensatory Movements With Axon-Hook and Greifer in Transradial Amputees
Official title: Randomized Crossover Trial Comparing Shoulder Abduction Movements, Manual Dexterity and Satisfaction of Transradial Amputees Using Axon-Hook and Greifer Myoelectric Hooks.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transradial Amputation
Keywords: shoulder compensatory movements
myoelectric hooks
manual dexterity
satisfaction
Axon-Hook
Greifer
Lead sponsor: Otto Bock France SNC
Sponsor class: INDUSTRY
Collaborators: name: Euraxi Pharma
First posted: 2020-08-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized crossover trial (AB/BA)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Average shoulder abduction measure
timeFrame: One minute
Secondary outcomes:
measure: Percentage of time spent with shoulder abduction more or equal to 60°
timeFrame: One minute
measure: Manual dexterity
timeFrame: One minute
measure: User satisfaction
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Nancy
country: France
facility: Institut Régional de Rééducation et de Réadaptation
state: Lorraine
Study officials:
affiliation: Institut Régional de Rééducation et de Réadaptation de Nancy
name: Amélie TOUILLET
role: PRINCIPAL_INVESTIGATOR
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