Clinical Trials Logo

Clinical Trial Summary

Lower limb amputees suffer complete lack of sensory feedback of current available prostheses, which excludes the central nervous system from the correct sensory-motor integration. It causes serious problems as: falls due to unexpected perturbations, asymmetric walking, low mobility, higher power consumption, feeling the prosthesis as a foreign body, high cognitive burden, and phantom limb pain occurrence.

Investigators will provide amputees with a prosthesis restoring sensory feedback and will assess its benefits on the users.


Clinical Trial Description

The clinical investigation described here aims at evaluating the benefit of a lower limb prosthesis providing sensory feedback (bidirectional prosthesis), in selected transfemoral amputees. The device is constituted by i) Rheo Knee XC, Pro Flex foot and customized socket/liner structure from OSSUR. Rheo Knee embedded already an encoder coupled with a Bluetooth unit, which is used to make communication with devices external to the knee itself; ii) nerve stimulating system constituted by implantable intraneural electrodes from IMTEK, iii) an external neurostimulator from AXONIC, and iv) sensorized sole from SensArs Neuroprosthetics to apply under the prosthetic foot and driving the stimulating system. The readout of the sensorized insole are transmitted via Bluetooth, together with the encoder readout, to an external controller, which transduces it in parameters of stimulation. These parameters are sent to the stimulator, which injects current into the intraneural electrodes. As final result, the subject perceives sensory feedback from the prosthesis when using it.

Investigators call SENSY the sensory feedback restoration system. The subjects will use the prosthesis with and without sensory feedback to execute walking tasks. The average change of kinematics (including falls), metabolic cost, embodiment, and cognitive burden (EEG) when intraneural stimulation is provided will be compared to the case in which there is no sensory feedback. Standard clinical tests (as PEQ and CB&MS) will be executed with and without sensory feedback. Also, when the subjects will report attacks of phantom pain, they will undergo a 10-minutes-stimulation session. Only stimulation without prosthesis is used in this intervention.

Finally, imaging of the cortical activity will be executed through functional magnetic resonance imaging (fMRI). This procedure will be only observational since no prosthesis or sensory feedback will be used by the subjects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03350061
Study type Interventional
Source Clinical Centre of Serbia
Contact
Status Completed
Phase N/A
Start date November 12, 2017
Completion date July 14, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT03947450 - Autologous Volar Fibroblast Injection Into the Stump Site of Amputees Phase 2
Completed NCT04924036 - Qbrexza Cloths for Hyperhidrosis of Amputation Sites Phase 2
Recruiting NCT04839497 - Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees. Phase 2
Recruiting NCT04212299 - Transfemoral Socket Design and Muscle Function N/A
Completed NCT03733054 - Understanding Prosthetic Needs and Outcomes in Women Veterans With Amputation
Completed NCT03651830 - A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations N/A
Recruiting NCT04725006 - Sensory Responses to Dorsal Root Stimulation N/A
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT04936789 - Clinical Feasibility of the IMES Transradial Prosthesis N/A
Completed NCT01155024 - Clinical Evaluation of Direct Manufactured Prosthetic Sockets Phase 2
Completed NCT00663663 - Telephone Intervention for Pain Study (TIPS) N/A
Terminated NCT00778856 - Hand Transplantation for the Reconstruction of Below the Elbow Amputations N/A
Recruiting NCT00388752 - Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation Phase 1
Active, not recruiting NCT03374319 - Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations N/A
Completed NCT05542901 - Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees N/A
Completed NCT05161364 - Kinetic Analysis Due to Foot Dysfunction
Recruiting NCT06194838 - Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees N/A
Completed NCT03570788 - HRQoL Among Patients Amputated Due to Peripheral Arterial Disease
Completed NCT05778799 - Physical Activity and Sports for People With Special Needs
Recruiting NCT04804150 - Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System N/A