Adjustable prosthetic sockets for children and adolescents with

Build status - In Progress

Recruiting

3 years - 18 years

All

Phase 2

40 participants needed

1 Location

Brief description of study

This study aims to develop an adjustable, immediate fit prosthetic device for children age 3- 18 which will accommodate growth. We are looking for children with lower limb amputation- above knee, below knee and symes amputations.

All testing will be done within the PM&R Gait Lab located at 1800 Lombard St, Philadelphia, PA. Participants will be fit with an adjustable lower limb prosthetic socket to obtain feedback and evaluate the design of the adjustable prosthetic.

For Phase II, we will conduct a two month home trial to fully evaluate the adjustable socket.

Detailed description of study

The parents of the participant will send in measures and pictures of the child's limb in order to create a prototype prior to the first visit. The adjustable socket will be fit on the child in the gait lab and the child will be asked to ambulate. The child and parent will give their impressions and feedback on the design.

For Phase II, children will wear the prosthesis for a two month time period. They will fill out an evaluation of their current socket, and have internal pressure measurements taken. When they return they will complete an evaluation on the adjustable socket and have pressure measurements taken. We will also conduct a gait analysis of the participant in their socket and the adjustable socket. We may also ask the child to complete a gait analysis which involves walking several times back and forth in the gait lab.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: pediatric amputation,lower limb amputation,transtibial amputation,transfemoral amputation,congenital limb loss
Age: 3 years - 18 years
Gender: All

Key inclusion criteria

Four months post-amputation

Age 3-18
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.

Key exclusion criteria

1) open skin lesions, 2) excessive pain in the residual limb (phantom pain, residual limb pain, or neuroma), 3) neurological disorders (e.g., stroke, severe polyneuropathy) causing weakness in the contralateral leg or marked gait impairment, 4) inability to follow instructions for trial

Updated on 04 Aug 2024. Study ID: 849980

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