Transradial AmputationNCT04522349
Compensatory Movements With Axon-Hook and Greifer in Transradial Amputees
A study testing Greifer then Axon-Hook and Axon-Hook then Greifer in people with Transradial Amputation, run by Otto Bock France SNC at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transradial Amputation
- What is being tested?
- Greifer then Axon-Hook and Axon-Hook then Greifer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2016to 14 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Régional de Rééducation et de Réadaptation
Nancy, Lorraine, 54000
About this study
Official title: Randomized Crossover Trial Comparing Shoulder Abduction Movements, Manual Dexterity and Satisfaction of Transradial Amputees Using Axon-Hook and Greifer Myoelectric Hooks.
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.
Read the 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.
- Conditions
- Transradial Amputation
- Being tested
- Greifer then Axon-Hook, Axon-Hook then Greifer
- Keywords
- shoulder compensatory movements, myoelectric hooks, manual dexterity, satisfaction, Axon-Hook, Greifer
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greifer then Axon-HookDevice
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 GreiferDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Greifer then Axon-Hook | Active comparator | T0 + 2 weeks: evaluation with Greifer. T1 + 2 weeks: evaluation with Axon-Hook Receives: Device: Greifer then Axon-Hook |
| Axon-Hook then Greifer | Active comparator | T0 + 2 weeks: evaluation with Axon-Hook. T1 + 2 weeks: evaluation with Greifer Receives: Device: Axon-Hook then Greifer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average shoulder abduction measure
Average measure of shoulder abuction during Box and Blocks manual dexterity test, by motion analysis
Measured: One minute
Secondary outcomes (3)
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
Measured: One minute
Manual dexterity
Score at the Box and Blocks test
Measured: One minute
User satisfaction
Score at the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start29 Sep 2016
- Primary completion14 Feb 2017
- Study completion14 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Transradial AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized crossover trial (AB/BA)
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otto Bock France SNC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
- Investigators
- Amélie TOUILLET, Principal investigator, Institut Régional de Rééducation et de Réadaptation de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522349
- Sponsor's protocol ID
- 20PT003-FR-01-0516
- Other IDs
- 2016-A00897-44
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
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.
PubMed 25192744Carey 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.
PubMed 19367522Metzger 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.
PubMed 22449551Ostlie 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.
PubMed 22133243Bertels T, Schmalz T, Ludwigs E. Objectifying the functional advantages of prosthetic wrist flexion. J Prosthet Orthot. 2009;21(2):74-8.
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.
PubMed 26979272Resnik L, Borgia M, reliability and validity of outcome measures for upper limb amputation. JPO. 2012;24:192-201
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.
PubMed 25356979Haverkate 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.
PubMed 25336050Mathiowetz 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.
PubMed 3160243Carey 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.
PubMed 18675497Bouwsema 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.
PubMed 20362374Loiret 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.
PubMed 15932782Demers 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.
PubMed 10159726
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Crossover Trial Comparing Shoulder Abduction Movements, Manual Dexterity and Satisfaction of Transradial Amputees Using Axon-Hook and Greifer Myoelectric Hooks.
- ClinicalTrials.gov ID
- NCT04522349
- Acronym / sponsor ID
- 20PT003-FR-01-0516
- Conditions
- Transradial Amputation
- Keywords
- shoulder compensatory movements, myoelectric hooks, manual dexterity, satisfaction, Axon-Hook, Greifer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Otto Bock France SNCIndustry (pharma, biotech, devices)
- Collaborators
- Euraxi Pharma
- Study start
- 29 Sep 2016 (actual)
- Primary completion
- 14 Feb 2017 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized crossover trial (AB/BA)
| Arm | Type | Receives |
|---|---|---|
| Greifer then Axon-Hook | Active comparator | Device: Greifer then Axon-HookT0 + 2 weeks: evaluation with Greifer. T1 + 2 weeks: evaluation with Axon-Hook |
| Axon-Hook then Greifer | Active comparator | Device: Axon-Hook then GreiferT0 + 2 weeks: evaluation with Axon-Hook. T1 + 2 weeks: evaluation with Greifer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Greifer then Axon-HookEach 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. | Device | Greifer then Axon-Hook |
| Axon-Hook then GreiferEach 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. | Device | Axon-Hook then Greifer |
Primary outcome
Average shoulder abduction measure
Time frame: One minute
Average measure of shoulder abuction during Box and Blocks manual dexterity test, by motion analysis
3 secondary outcomes
Percentage of time spent with shoulder abduction more or equal to 60°
Time frame: One minute
Manual dexterity
Time frame: One minute
User satisfaction
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- BackgroundA.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: PubMed 25192744Major 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.
- Background: PubMed 19367522Carey 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.
- Background: PubMed 22449551Metzger 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.
- Background: PubMed 22133243Ostlie 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.
- BackgroundBertels T, Schmalz T, Ludwigs E. Objectifying the functional advantages of prosthetic wrist flexion. J Prosthet Orthot. 2009;21(2):74-8.
- Background: PubMed 26979272Deijs 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.
- BackgroundResnik L, Borgia M, reliability and validity of outcome measures for upper limb amputation. JPO. 2012;24:192-201
- Background: PubMed 25356979Hebert 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.
- Background: PubMed 25336050Haverkate 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.
- Background: PubMed 3160243Mathiowetz 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.
- Background: PubMed 18675497Carey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amélie TOUILLET principal investigator
Institut Régional de Rééducation et de Réadaptation de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Greifer then Axon-Hook and Axon-Hook then Greifer in people with Transradial Amputation, run by Otto Bock France SNC at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average shoulder abduction measure (time frame: One minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04522349, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.