Active — Not RecruitingNot Applicable

Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth

United States28 participantsStarted 2022-08-18

Plain-language summary

An immediate fit adjustable prosthetic system is being investigated for children. The age range being recruited is from 3 years up to 18 years old. Phase I of this study will involve developing a final prototype by conducting in-lab testing on children with limb loss. Phase II will involve a two month home trial to further evaluate the comfort and usability of the socket. Outcome measures include a PEQ-based questionnaire, socket pressure measures and gait analysis.

Who can participate

Age range3 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Four months post-amputation * Subjects who have lost a limb due to any cause: trauma, congenital limb loss, dysvascular causes (peripheral vascular disease and diabetes), or malignancy will all be eligible for inclusion. * Intact, protective sensation in their residual limbs. Exclusion Criteria: * open skin lesions * excessive pain in the residual limb (phantom pain, residual limb pain, or neuroma) * neurological disorders (e.g., stroke, severe polyneuropathy) causing weakness in the contralateral leg or marked gait impairment * inability to follow instructions for trial

What they're measuring

Modified Prosthetic Evaluation Questionnaire

Timeframe: 2 months

Internal Socket Pressures

Timeframe: 2 months

Socket Comfort Score

Timeframe: 2 months

Gait Speed

Timeframe: 2 months

PedsQL

Timeframe: 2 months

CAPP-PSI

Timeframe: 2 months

Trial details

NCT IDNCT05230004

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-07

View on ClinicalTrials.gov More Limb Deficiencies trials