Rectus Femoris Thickness Measurement in Unilateral Transtibial Amputated Prosthesis Users

NCT04262297 | Completed

• 1 other identifier: 09.2018.025
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Knee extension strengthening is one of the cornerstones of rehabilitation in prosthesis users with transtibial amputation. It is recommended in terms of increasing functional mobility, preventing the risk of fall and knee osteoarthritis. Therefore, there is a need for objective measurements to evaluate changes in functional strength and walking through the rehabilitation process. Muscle thickness measured by ultrasound was found to be valid and highly correlated with magnetic resonance imaging and dual-energy X-ray absorptiometry measurements and shown to reflect the strength and functional outcomes in various diseases. The first aim of this study is to reveal the rectus femoris muscle thickness alteration in prosthesis users with transtibial amputation compared to able-bodied controls and establish its correlation with functional strength and walking tests. The second aim is to determine intra- and inter-rater reliability and construct validity of the rectus femoris muscle thickness measured by ultrasound in prosthesis users with transtibial amputation.

Conditions

Amputation, Traumatic

Keywords

Amputees; Quadriceps MuscleMuscle Strength; Muscle Strength

Outcome Measures

Primary Outcomes (1)

• Ultrasonographic cross-sectional area of rectus femoris measurement

  Images were obtained at the bulkiest area of muscle at mid-thigh (midway between the anterior superior iliac spine and the upper pole of the patella) while the participant lay in the supine position with lower limbs are extended and relaxed. The probe was held axially with a light touch in order not to cause any difference in the muscle volume. The rectus femoris cross-sectional area of both limbs (CSA-RF) (mm2) was calculated.

  through study completion, an average of 6 months

Secondary Outcomes (3)

• Knee extension strength measurement via handheld dynamometer

  through study completion, an average of 6 months

• Step-up-over Test

  through study completion, an average of 6 months

• Walk-across Test

  through study completion, an average of 6 months

Study Arms (2)

Prosthesis users

Prosthesis users with transtibial amputation

Able-bodied Controls

Prosthesis users' age-, sex- and dominancy-matched healthy controls

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prosthesis users with transtibial amputation and their age-, sex- and dominancy-matched (1:1) able-bodied controls to provide an amputation-independent reference were included.

You may qualify if:

• Unilateral transtibial amputation on the right side
• Using the prosthesis for more than 1 year
• Able to use the prosthesis without pain and discomfort
• Able to walk without a walking aid

You may not qualify if:

• Presence of concomitant health issues (diabetes mellitus, peripheral artery disease, and other vascular diseases etc.)
• Ongoing pathology with the contralateral or residual limb (pressure sore or ulcer etc.)
• Taking medication that is known to affect balance

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Amputation, Traumatic

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Kardelen Gencer Atalay

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: October 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: May 1, 2019
• Last Updated: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)