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Completed

NCT Number: NCT04522349

Compensatory Movements With Axon-Hook and Greifer in Transradial Amputees

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.

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Key information

Conditions

Transradial Amputation Behavior Personal Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Régional de Rééducation et de Réadaptation

Nancy, Lorraine, 54000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

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

    Time frame: One minute

    Percentage of time spent with shoulder abduction more or equal to 60° during Box and Blocks test

  2. Manual dexterity

    Time frame: One minute

    Score at the Box and Blocks test

  3. User satisfaction

    Time frame: 15 minutes

    Score at the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)

Sponsors and collaborators

Lead sponsor

Otto Bock France SNC

Industry

Collaborators

  • Euraxi Pharma

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 21, 2020
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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