A Sensorimotor Prosthesis for the Upper Limb
NCT05220553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2025-03-24
Summary
The finger and fingertip are the most frequently amputated body parts, due to work-related incidents. Yet because of space, weight and cost constraints, prosthetic fingers and fingertips are heavy and bulky with limited active motion and sensation. Most are basic variations on the hook and claw. Lower limb prostheses have become extremely technologically advanced in their design and materials, and upper limbs lag behind in all of these areas. This is due to the complexity of the anatomy and function of the upper limb compared to the lower. There are no commercially available prostheses that offers direct sensory feedback and as such, rely on visual feedback from the wearer.
The original PROLIMB study (PROLIMB I) used a Leap Motion Controller (LMC) to investigate the type of grasp adaptation that have been undertaken by patients during the rehabilitation process following amputation and compared this to similar data from healthy volunteers. PROLIMB I also looked at refining the tactile feedback system by investigating the sensation felt on amputation sites in order to feed this information into the haptic feedback system.
The vision of the PROLIMB II project is to build on the work completed in PROLIMB I and develop and combine mechanistic models of hand motion and haptic sensing to deliver novel, affordable body-powered prosthetic fingertip digits with enhanced motion and sensation to address current clinical needs and support the quality of life of amputees. With collaboration from the University of Warwick (UoW) and University College London (UCL), Steeper Group and Naked Prosthetics the PROLIMB II study will aim to model, design, fabricate and validate a body-powered prosthetic fingertip digit with integrated sensory feedback. The University Hospital Coventry \& Warwickshire (UHCW) will provide the clinical facility with which to assess the comfort, usability and acceptance of this prosthetic in the daily lives of patients with digit amputations. This project will be a proof of concept study with verification of the prosthetic in motion capture (gait) laboratories as well as the use of simple validation data collection over a longer period.
Conditions
- Prosthesis Durability
- Prosthesis User
- Amputation
- Amputation; Traumatic, Hand
Interventions
- DEVICE
-
PROLIMB Prosthesis
Participants will be given the PROLIMB prosthesis to test in the lab and to use in their daily lives
Sponsors & Collaborators
-
University of Warwick
collaborator OTHER -
University College, London
collaborator OTHER -
University Hospitals Coventry and Warwickshire NHS Trust
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-10
- Primary Completion
- 2024-08-16
- Completion
- 2024-08-16
- FDA Device
- Yes
Countries
- United Kingdom
Study Locations
More Related Trials
-
Use of Hand Prosthesis With Direct Nerve Stimulation for Treatment of Phantom Limb Pain
NCT02796495 ·Status: WITHDRAWN ·Phase: NA
-
Use of Hand Prosthesis With Direct Nerve Stimulation for Treatment of Phantom Limb Pain
NCT02506608 ·Status: COMPLETED ·Phase: NA
-
Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses
NCT03876405 ·Status: COMPLETED ·Phase: NA
-
Functional Importance of a Powered Multifunction Wrist Protocol
NCT04069793 ·Status: COMPLETED ·Phase: NA
-
Clinical Evaluation of Intuitive, Bidirectional Strategies for the Control of Multi-articulated Prostheses for Upper Limb Amputation
NCT06886295 ·Status: RECRUITING ·Phase: NA
-
A Unique Body-Powered Terminal Device With Enhanced Grasping Capabilities for Individuals With Upper Limb Loss
NCT07254247 ·Status: COMPLETED ·Phase: NA
-
Evaluation of a Multi-electrode Prosthesis Control System for Real-world Tasks Performance in Individuals With Upper Limb Transradial Amputation
NCT07071584 ·Status: WITHDRAWN ·Phase: NA
-
Observational Study of People with Complete Hand Amputation Using a Multi-grip Myoelectric Prosthesis a Following Using a Standard Myoelectric Prosthesis
NCT06452472 ·Status: COMPLETED
-
Pattern Recognition Prosthetic Control
NCT04272593 ·Status: COMPLETED ·Phase: NA
-
Identify the Prosthesis Users' Necessities Concerning Their Devices.
NCT06128135 ·Status: ENROLLING_BY_INVITATION
-
Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback?
NCT05505513 ·Status: RECRUITING ·Phase: NA
-
Phantom Limb Pain: Efficacy of Non-invasive Sensory Feedback Through the Prosthesis
NCT02589080 ·Status: COMPLETED ·Phase: NA
-
Strategies to Control Robotic Hand Prosthesis Via HD-sEMG and to Restore Sensory Feedback Via TENS
NCT06486571 ·Status: RECRUITING ·Phase: NA
-
Feasibility of Implantable Myoelectric Sensors to Control Upper Limb Prostheses
NCT01901081 ·Status: COMPLETED ·Phase: NA
-
Study of Compensatory Motion While Using an Upper Limb Prosthesis
NCT00417352 ·Status: COMPLETED ·Phase: NA
-
Enhancing Upper Limb Prostheses With Radio Frequency Identification
NCT01967004 ·Status: UNKNOWN ·Phase: NA
-
Improving Myoelectric Prosthetic and Orthotic Limb Control
NCT05509101 ·Status: RECRUITING ·Phase: NA
-
Effects of Myoelectric Channel Count and Targeting for Upper Limb Prosthetic Control
NCT07011420 ·Status: RECRUITING ·Phase: NA
-
Movement and Sensation for Advanced Prosthetic Hands
NCT03259386 ·Status: TERMINATED
-
Compensatory Movements With Axon-Hook and Greifer in Transradial Amputees
NCT04522349 ·Status: COMPLETED ·Phase: NA
-
Pattern Recognition Prosthetic Control
NCT04272489 ·Status: COMPLETED ·Phase: NA
-
Assessment of Gesture Accuracy of a Prosthesis Control System
NCT06446037 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Myoelectric SoftHand Pro to Improve Prosthetic Function for People With Below-elbow Amputations: A Feasibility Study
NCT02274532 ·Status: COMPLETED ·Phase: NA
-
Assessment of Feasibility, Functionality and Usability of an Hybrid Assistive Exoskeleton for Upper Limb
NCT07000279 ·Status: RECRUITING ·Phase: NA
-
Safety and Efficacy of Vibro-tactile Feedback for Patients Who Underwent Lower Limb Amputation
NCT05895253 ·Status: TERMINATED ·Phase: NA