Rectus Femoris Thickness Measurement in Unilateral Transtibial Amputated Prosthesis Users

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.

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Key information

Conditions

Amputation, Traumatic Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University

Istanbul, 34899, Turkey (Türkiye)

About this study

Bilateral rectus femoris muscle thickness was measured by two independent examiners using an ultrasound. Bilateral knee extension strength was measured via handheld dynamometer (Jamar, Bolingbrook, IL, USA). Functional strength and walking were assessed by Step-up-over (SUO) and Walk-across (WA) tests of NeuroCom Balance Master® device (NeuroCom International, Clackamas, OR, USA).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Ultrasonographic cross-sectional area of rectus femoris measurement

Time frame: through study completion, an average of 6 months

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.

Secondary outcomes

Knee extension strength measurement via handheld dynamometer

Time frame: through study completion, an average of 6 months

The dynamometer was located 5 cm above the intermalleolar line to measure bilateral knee extension strength. All participants were tested while lying supine position with a support behind the knees to achieve approximately 30° of flexion. For the amputated-limb, the prosthesis was used in place.
Step-up-over Test

Time frame: through study completion, an average of 6 months

All participants were asked to stand still behind the box placed on the pressure platform and to move immediately after seeing the sign on the computer screen. The movement was defined as three phases: first stepping onto the box with one limb, second carrying the body over the box, and third landing with the other limb on the opposite side of the box. The average lift-up index (%), movement time (s), and the impact index for both limbs calculated after three repetitions.
Walk-across Test

Time frame: through study completion, an average of 6 months

All participants were asked to stand still and to walk as fast as possible along with the pressure platform after seeing the sign on the computer screen. The average step width (cm), step length (cm), and speed (cm/s) were calculated after three repetitions.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Relation Between Ultrasonographic Rectus Femoris Thickness Measurement and Functionality in Unilateral Transtibial Amputated Prosthesis Users

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Feb 10, 2020
Registry last updated: Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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