Rectus Femoris Thickness Measurement in Unilateral Transtibial Amputated Prosthesis Users

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-05-01

Brief Summary

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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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Detailed Description

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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).

Conditions

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Amputation, Traumatic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Prosthesis users

Prosthesis users with transtibial amputation

No interventions assigned to this group

Able-bodied Controls

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

No interventions assigned to this group

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes