Upper Limb Prosthetics for Amputation

Overseen By Laura Miller, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: New injury, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different arm prosthetics assist people with below-the-elbow amputations in managing daily tasks. Researchers use a special tool to assess how these prosthetics affect body movements. Participants will test various experimental prosthetics featuring wrist rotation and flexible hand movements. Individuals with below-the-elbow amputations who can use a myoelectric prosthesis (controlled by muscle signals) are ideal candidates for this study.

As an unphased trial, this study provides a unique opportunity to advance prosthetic technology and enhance daily life for future users.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these prosthetic devices are safe for use?

Research has shown that prosthetic devices for people with upper limb amputations are generally safe. For example, tests on the Manus Hand, a type of prosthetic hand, found it safe and effective for users. This device helps individuals perform daily tasks without major problems.

One study examined a prosthetic design that allows the wrist to rotate and move in multiple directions, aiming to make arm movements more natural. These studies confirm that users well-receive such prosthetics.

Additionally, research on prosthetics with wrist rotation and bending features shows these help users avoid awkward movements, allowing for more natural, comfortable, and safer movement.

Overall, while testing continues, previous studies suggest these devices are generally safe for people with upper limb amputations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these prosthetic treatments for upper limb amputations because they offer advanced functionality beyond typical prosthetics. Unlike standard prosthetics, which often provide limited movement, these experimental models include wrist rotation and flexion with either a single degree of freedom (1-DOF) or a multi-degree freedom (Multi-DOF) hand. This allows for more natural and versatile hand movements, enabling users to perform tasks with greater ease and precision. The incorporation of eye-tracking technology further enhances the control and integration of these prosthetics with the user's natural movements. This innovation could significantly improve the quality of life for individuals with transradial amputations by providing more dynamic and intuitive arm functionality.

What evidence suggests that this trial's prosthetic devices could be effective for upper limb amputation?

This trial will evaluate various experimental prosthetic designs for individuals with transradial amputations. Studies have shown that prosthetics with wrist rotation, which participants in this trial may receive, can restore natural arm movements and reduce the need for awkward adjustments. For those receiving prosthetics with a hand that moves in multiple directions, adding wrist rotation and bending can simplify daily tasks. Research indicates that these prosthetics provide results similar to natural wrist movement over the medium term without causing additional complications. Clinical evaluations of these multi-directional hands have demonstrated their safety and effectiveness for users. Overall, these advanced prosthetic designs aim to improve usability and comfort, helping individuals with below-the-elbow amputations perform daily activities more naturally. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with a unilateral upper limb amputation below the elbow who can use a myoelectric prosthesis and speak English. It excludes those with cognitive impairments affecting study participation, significant other comorbidities, or new injuries preventing prosthesis use.

Inclusion Criteria

I have one arm amputated or missing below the elbow.

I can use a limb prosthesis controlled by muscle signals.

Exclusion Criteria

Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers

I can wear a prosthesis and do daily tasks without major new injuries.

I understand and can follow the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the experimental prosthesis and perform tasks such as the Cup Transfer Task and Pasta Box Task to assess kinematics and gaze behavior

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clinically prescribed prosthesis
• Experimental prosthesis - Wrist rotation + 1-DOF
• Experimental prosthesis - Wrist rotation + Multi DOF hand
• Experimental prosthesis - Wrist rotation + Wrist flexion +1-DOF
• Experimental prosthesis - Wrist rotation + wrist flexion + Multi DOF hand

Trial Overview The study evaluates how different prosthetic components affect daily living activities using the GaMA metric. Participants will try various experimental prostheses that offer wrist rotation, multi-degree-of-freedom hands, and wrist flexion to measure their functionality.

How Is the Trial Designed?

Group I: Transradial amputee participants - Wrist rotation+1 dof hand Experimental Treatment 1 Intervention

Individuals with transradial amputation fit with experimental prosthesis consisting of wrist rotation and one degree of freedom hand. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant will wear a headband with attached markers for eye tracking. The participant will pick up and move objects of different shapes to and from various heights.

Group II: Transradial amputee participants - Wrist rotation + wrist flexion +1 dof hand Experimental Treatment 1 Intervention

Individuals with transradial amputation fit with experimental prosthesis consisting of wrist rotation, wrist flexion and one degree of freedom hand. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant will wear a headband with attached markers for eye tracking. The participant will pick up and move objects of different shapes to and from various heights.

Group III: Transradial amputee participants - Wrist rotation + wrist flexion + multi degree freedom hand Experimental Treatment 1 Intervention

Individuals with transradial amputation fit with experimental prosthesis consisting of wrist rotation, wrist flexion and multi degree freedom hand. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant will wear a headband with attached markers for eye tracking. The participant will pick up and move objects of different shapes to and from various heights.

Group IV: Transradial amputee participants - Wrist rotation + multi degree freedom hand Experimental Treatment 1 Intervention

Individuals with transradial amputation fit with experimental prosthesis consisting of wrist rotation and multi degree freedom hand. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant will wear a headband with attached markers for eye tracking. The participant will pick up and move objects of different shapes to and from various heights.

Group V: Able-bodied participants Active Control 1 Intervention

Participants without amputation were enrolled to collect normative data for system validation. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant wears a specialized headband/glasses with an attached camera for eye tracking. The participant will pick up and move objects of different shapes to and from various heights.

Group VI: Transradial amputee participants Active Control 1 Intervention

Individuals using their home prosthesis when available. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant will wear a headband with attached markers for eye tracking. The participant will pick up and move objects of different shapes to and from various heights.

Clinically prescribed prosthesis is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Upper Limb Prosthetic Devices for:

• Amputations above or below the elbow
• Hand and finger amputations

Approved in United States as Upper Limb Prosthetic Devices for:

• Transradial and transhumeral amputations
• Forequarter and shoulder disarticulation amputations

Approved in Canada as Upper Limb Prosthetic Devices for:

• Upper limb amputations
• Hand and finger prosthetics

Approved in Japan as Upper Limb Prosthetic Devices for:

• Transradial and transhumeral prosthetics
• Myoelectric and body-powered prosthetics

Approved in China as Upper Limb Prosthetic Devices for:

• Upper limb prosthetics
• Artificial limbs for daily activities

Approved in Switzerland as Upper Limb Prosthetic Devices for:

• Transradial and transhumeral amputations
• Forequarter and shoulder disarticulation amputations

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

Published Research Related to This Trial

The study found that adding a passive wrist flexor to a single degree of freedom prosthetic hand improved grasping function, with the overall functional score increasing from 80 to 83 when using the wrist flexion unit.

Both types of passive wrist designs enhanced performance in various grip types, particularly improving the speed and ease of completing tasks, indicating that wrist mobility is beneficial for prosthetic functionality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of passive wrist joints on the functionality of prosthetic hands. Kyberd, PJ.[2019]

A total of 25 cadavers were studied to determine the mechanical requirements for achieving muscular balance in a total wrist prosthesis, leading to the design of a compatible prosthesis with a torus surface.

The prosthesis required only slightly greater forces than normal muscle activity for movement, and after one year of use in a male patient, the results were deemed satisfactory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Total radiocarpal prosthesis. Preliminary study]. Gagey, O., Lanoy, JF., Mazas, Y., et al.[2006]

A study involving 15 participants with trans-radial amputations revealed that many users struggle with daily activities requiring the 'Dart Thrower's Motion', which combines wrist flexion and deviation, indicating a significant gap in current prosthetic wrist functionality.

Participants expressed a strong preference for incorporating flexion and deviation over rotation in prosthetic wrists, suggesting that future designs should focus on these motions to enhance usability and improve quality of life for upper limb amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User surveys support designing a prosthetic wrist that incorporates the Dart Thrower's Motion. Davidson, M., Bodine, C., Weir, RFF.[2021]

The newly designed wrist prostheses (mono-articular type A and bi-articular type B) provide improved rotatory stability and physiological ranges of motion compared to existing prostheses, which have limitations in stability and motion transmission.

These prostheses were tested on cadaveric specimens and showed promising results, indicating they could effectively restore normal wrist function, but further studies are needed to optimize their dimensions for individual patients before clinical trials begin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Principles and experimentation of wrist prostheses of the universal joint type. Kapandji, IA.[2019]

The 3SPS-S-3RRR mechanism developed for upper limb wrist prosthetics allows for quasi-spherical motions, effectively mimicking the natural flexion and extension of a healthy wrist.

This innovative design also incorporates rotational motion to enable pronation and supination, enhancing the functionality of wrist prosthetics without needing additional motors, which could improve usability for amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inverse Kinematics of a Parallel Mechanism with an Offset Structural Design for Prosthetic Wrist Motions. Seo, H., Chakragiri, A., Purushothapu, M., et al.[2022]

In a study comparing 41 total wrist fusions and 22 total wrist prostheses over a mean follow-up of 6 years, both interventions showed similar outcomes in grip strength, pain levels, and overall function.

Total wrist prostheses can be a viable option for patients with low to moderate functional demands, providing comparable medium-term results to total wrist fusions without increasing complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total wrist fusion versus total wrist prosthesis: a comparative study. Rodríguez-Nogué, L., Martínez-Villén, G.[2023]

A study comparing different prosthetic hand-wrist designs found that a single degree of freedom (DoF) wrist with flexion/extension can provide functionality similar to more complex multi-DoF hands, reducing the need for compensatory movements.

This research suggests that improving wrist design in prosthetics could enhance task performance for transradial amputees while minimizing discomfort and overuse injuries, highlighting the importance of focusing on wrist functionality in future prosthetic development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it Finger or Wrist Dexterity That is Missing in Current Hand Prostheses? Montagnani, F., Controzzi, M., Cipriani, C.[2015]

The new compact prosthetic wrist design utilizes two motors and a differential mechanism, allowing for wrist flexion, extension, pronation, and supination while fitting within the limited space of the hand.

Controlled by a single user through myoelectric signal pattern recognition, this two-degree-of-freedom wrist enhances the functionality of prosthetic hands by better aligning hand orientation with grasping needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-degree-of-freedom powered prosthetic wrist. Kyberd, PJ., Lemaire, ED., Scheme, E., et al.[2022]

Cemented wrist implants have a high failure rate of 15%-30% within five years, indicating a need for careful selection and evaluation of implant designs.

When revising failed wrist implants, surgeons must assess the stability of the wrist and consider options like resection, total joint arthroplasty, or wrist arthrodesis for better long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total wrist arthroplasty. Problems with implant failures. Cooney, WP., Beckenbaugh, RD., Linscheid, RL.[2016]

The study introduces a novel 2-degree-of-freedom prosthetic wrist that enhances dexterity by allowing active pronation/supination and passive elastic flexion/extension, which can improve handling skills and reduce compensatory movements that may lead to injuries.

This prosthetic wrist module can support a load of 3 kg and offers a range of motion of ±75°, making it adaptable for various hand prostheses and promoting more natural and physiological movements compared to traditional fixed prosthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a modular and compliant wrist module for upper limb prosthetics. Demofonti, A., Carpino, G., Tagliamonte, NL., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06420687

GaMA Metric to Quantify Functional Importance of Various ... Individuals with transradial amputation fit with experimental prosthesis consisting of wrist rotation and one degree of freedom hand. Adhesive motion capture ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10552222/

Restoring natural upper limb movement through a wrist ... Integrating a wrist rotation module in prosthetic hand designs for partial hand amputees restores natural upper limb movement patterns, reduces compensatory ...

3. withpower.com withpower.com/trial/phase-amputation-traumatic-limb-3-2020-0e3bc

Upper Limb Prosthetics for Amputation · Info for Participants Research indicates that total wrist prostheses can offer medium-term functional results similar to wrist fusion without increasing complications, ...

4. clinicaltrial.be clinicaltrial.be/en/details/83655?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Functional Importance of a Powered Multifunction Wrist Pr... The primary objective of this project is to evaluate the functional importance of a multi function wrist compared to a single degree of freedom wrist.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1350453325001511

Clinical Evaluation of Prosthetic Hand: A Systematic ... The Manus Hand underwent clinical testing on three individuals with upper-limb amputations, demonstrating safety, effectiveness, and enabling ...

6. anatomypubs.onlinelibrary.wiley.com anatomypubs.onlinelibrary.wiley.com/doi/10.1002/ar.24911

Design of a modular and compliant wrist module for upper ... Development of bionic prostheses characterized by personalized interfaces and sensorial feedback for amputee patients with macro lesion after car accident.

7. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/counter/pdf/10.1186/s12984-023-01259-9.pdf?utm_source=consensus

Restoring natural upper limb movement through a wrist ... Experiment 1 was conducted to verify the usability of the ADL of the proposed prosthetic hand using the wrist rotation module method, and a JHFT was conducted ...