Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees

University of Washington

Status: Completed

Conditions: Transtibial Amputee

Treatments: Device: Bioimpedance monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT03164356

STUDY00000969

Details and patient eligibility

About

The purpose of the proposed study is to conduct research on individuals with lower limb amputation, evaluating if residual limb fluid volume data collected using a novel non-invasive device is beneficial towards prosthetic prescription, fit, and comfort as determined by amputee test subjects and practitioners (prosthetists). Participants' residual limb fluid volume will be monitored through bioimpedance analysis both before and after a practitioner-issued modification to the prosthesis as an observational cohort study and then as a blinded randomized control trial in which the data may or may not be shared with the practitioner before the modification is made to the prosthesis.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Transtibial amputees, unilateral or bilateral
• Amputation at least 18 months prior
• Walking activity of at least 7 hours per week
• Medicare functional classification level of 2 or higher
• Residual limb length of at least 9 centimeters
• Detrimental impacts to socket fit caused by residual limb volume fluctuations
• Indication for augmented suspension, socket modification/change, sock application removal or activity modification

Exclusion criteria

• Incidence of skin breakdown
• Inability to ambulate continuously on a level walkway

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

---

68 participants in 3 patient groups

Arm 1

No Intervention group

Description:

In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.

Arm 2 - Experimental

Experimental group

Description:

Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3.

Treatment:

Device: Bioimpedance monitor

Arm 3 - Control

No Intervention group

Description:

Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist.