RECRUITING

Feasibility of Sensory Feedback for Lower Limb Amputees

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with lower limb loss, including above and below knee amputees. The approach involves delivering small electrical currents directly to remaining nerves via implanted stimulating electrodes. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how information about the foot and lower limb used to be transferred to your brain prior to the amputation. Individuals also have the option to have recording electrodes implanted within muscles of the lower limb(s) in an attempt to develop a motor controller that would enable the user to have intuitive control of a robotic prosthetic leg.

Official Title

Feasibility of Sensory Feedback for Lower Limb Amputees

Quick Facts

Study Start:2015-11-05
Study Completion:2027-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03409133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults age 18 or greater
  2. * Chronic, medically stable ( \> 3 months) unilateral trans-tibial or trans-femoral amputation
  3. * Potential user of trans-tibial or trans-femoral prostheses for standing or walking
  4. * Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials (SEP) and the like
  5. * Good skin integrity and personal hygiene
  6. * Absence of autoimmune deficiencies, seizure disorders or cardiac abnormalities contraindicating stimulation
  7. * Sufficient social support and personal ability to tolerate study procedures and comply with follow-up schedule
  1. * Uncontrolled diabetes with HbA1c greater than or equal to 69 mmol/mol (8.5%).
  2. * Significant vascular disease
  3. * Chronic skin ulcerations
  4. * Significant history of poor wound healing
  5. * Significant history of uncontrolled infections
  6. * Active infection
  7. * Significant pain in the residual or phantom limb
  8. * Pregnancy
  9. * Inability to speak English
  10. * Expectation that MRI will be required at any point for the duration of study or while percutaneous leads are in place
  11. * Arthritis in the area of implant
  12. * History of vestibular or movement disorders that would compromise balance or walking
  13. * Class II or III obesity (Body Mass Index \> 35)
  14. * Poor surgical candidate
  15. * Uncontrolled depression, psychoses or cognitive impairments

Contacts and Locations

Study Contact

Aarika Sheehan, PT, DPT
CONTACT
216-791-3800
Aarika.Sheehan@va.gov

Principal Investigator

Ronald Triolo, PhD
PRINCIPAL_INVESTIGATOR
Louis Stokes VA Medical Center

Study Locations (Sites)

Louis Stokes VA Medical Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: Louis Stokes VA Medical Center

  • Ronald Triolo, PhD, PRINCIPAL_INVESTIGATOR, Louis Stokes VA Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-11-05
Study Completion Date2027-09-01

Study Record Updates

Study Start Date2015-11-05
Study Completion Date2027-09-01

Terms related to this study

Keywords Provided by Researchers

  • prosthesis user
  • phantom sensation
  • sensory feedback
  • prosthesis
  • amputee
  • amputation
  • limb loss
  • robotic prosthesis
  • neuroprosthesis
  • sensory restoration
  • robotic
  • electromyography
  • EMG
  • sensation
  • myoelectric

Additional Relevant MeSH Terms

  • Amputation