Rectus Femoris Thickness Measurement in Unilateral Transtibial Amputated Prosthesis Users

Amputation, Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04262297
• Other study ID #: 09.2018.025
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: February 2020
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Unilateral transtibial amputation on the right side

2. Using the prosthesis for more than 1 year

3. Able to use the prosthesis without pain and discomfort

4. Able to walk without a walking aid

Exclusion Criteria:

1. Presence of concomitant health issues (diabetes mellitus, peripheral artery disease, and other vascular diseases etc.)

2. Ongoing pathology with the contralateral or residual limb (pressure sore or ulcer etc.)

3. Taking medication that is known to affect balance

Related Conditions & MeSH terms

• Amputation, Traumatic

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Knee extension strength measurement via handheld dynamometer	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.	through study completion, an average of 6 months
Secondary	Step-up-over Test	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.	through study completion, an average of 6 months
Secondary	Walk-across Test	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.	through study completion, an average of 6 months