Clinical trial NCT04262297: Rectus Femoris Thickness Measurement in Unilateral Transtibial Amputated Prosthesis Users
Official title: Relation Between Ultrasonographic Rectus Femoris Thickness Measurement and Functionality in Unilateral Transtibial Amputated Prosthesis Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation, Traumatic
Keywords: Amputees
Quadriceps MuscleMuscle Strength
Muscle Strength
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Ultrasonographic cross-sectional area of rectus femoris measurement
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Knee extension strength measurement via handheld dynamometer
timeFrame: through study completion, an average of 6 months
measure: Step-up-over Test
timeFrame: through study completion, an average of 6 months
measure: Walk-across Test
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: Kardelen Gencer Atalay
role: PRINCIPAL_INVESTIGATOR
References: