A Sensorimotor Prosthesis for the Upper Limb

NCT05220553 | Completed FDA Device

• 1 other identifier: JH596520
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• To demonstrate a difference in the performance when using the PROLIMB II prosthesis for simple daily motor tasks vs when completing without

  24 months

• To show a change in the fine motor skills of participants during the study using the VICON Motion Capture System.

  24 months

• Number of patients that show an acceptabilitys to use the PROLIMB II prosthesis in their daily lives using the QuickDASH questionnaire

  24 months

• Number of patients that show an acceptabilitys to use the PROLIMB II prosthesis in their daily lives using teh TAPES-R outcome measure

  24 months

• To show a change in the levels of sensation felt by the participant when using the prosthetic via the two point discrimination measure

  24 months

Study Arms (1)

Prosthesis

EXPERIMENTAL

Participants will be given the PROLIMB II prosthesis to trial in our lab and in their daily lives

Device: PROLIMB Prosthesis

Interventions

PROLIMB Prosthesis DEVICE

Participants will be given the PROLIMB prosthesis to test in the lab and to use in their daily lives

Prosthesis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead
• University of Warwick: collaborator
• University College, London: collaborator

Study Sites (1)

University Hospital Coventry and Warwickshire NHS Trust

Coventry, West Midlands, CV22DX, United Kingdom

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility Pilot Study

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 2, 2022
• Study Start: July 10, 2023
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

GB (1)