Amputation Clinical Trial
— PROLIMBOfficial title:
A Sensorimotor PROsthesis for the Upper LIMB
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.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | March 31, 2025 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Aged 18 or older - Had a previous unilateral finger/thumb digit(s) amputated (through accident or surgery) within the 12 months before consenting into the PROLIMB II study. - Amputated distal to proximal phalange/metacarpal joint - Have capacity to provide informed consent Exclusion Criteria: - Have been frequently using an alternative prosthetic for their digit amputations for over 1 month. - Still receiving active treatment or rehabilitation or healing for their residual digits at the time of screening. - Patients who are amputated at or proximal to the proximal phalange/metacarpal joint. - Allergic or hypersensitive to the material in contact with the skin - Evidence of neuroma causing point hypersensitivity |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital Coventry and Warwickshire NHS Trust | Coventry | West Midlands |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Coventry and Warwickshire NHS Trust | University College, London, University of Warwick |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To test the feasibility of using the PROLIMB II prosthesis for patients who have suffered recent finger/thumb digit amputations | Number of patients screened, recruited, withdrawn, retained and deemed suitable for using the PROLIMB II prosthesis. | 24 months | |
Secondary | To demonstrate a difference in the performance when using the PROLIMB II prosthesis for simple daily motor tasks vs when completing without | Number of participants who show a change in their motor function when using the YCB object and model set and Southampton Hand Assessment Procedure | 24 months | |
Secondary | To show a change in the fine motor skills of participants during the study using the VICON Motion Capture System. | Number of participants whose moments become more smooth and stable. 3D motion capture cameras and HD cameras will be used to finely track participants movements in order to quantify improvements in movement during routine tasks of the YCB model and object set and the Southampton Hand Assessment Procedure.. | 24 months | |
Secondary | Number of patients that show an acceptabilitys to use the PROLIMB II prosthesis in their daily lives using the QuickDASH questionnaire | QuickDASH questionnaire at bi-monthly intervals | 24 months | |
Secondary | Number of patients that show an acceptabilitys to use the PROLIMB II prosthesis in their daily lives using teh TAPES-R outcome measure | TAPES-R outcome measure at bi-monthly intervals | 24 months | |
Secondary | To show a change in the levels of sensation felt by the participant when using the prosthetic via the two point discrimination measure | Two point discrimination for measurements of sensation | 24 months | |
Secondary | To show a change in the levels of sensation felt by the participant when using the prosthetic via the mono filament test | Mono filament tests for measurements of sensation | 24 months |
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