RecruitingACTRN12622000512729

Functional outcomes for persons with above knee amputation fitted with different prosthesis types.

Assessment of balance, balance confidence, gait, and quality of life measures in persons with above-knee amputation, comparing those fitted with an osseointegrated prosthesis to those with a conventional socket prosthesis: a feasibility study.


Sponsor

Curtin University

Enrollment

20 participants

Start Date

Mar 27, 2022

Study Type

Observational

Conditions

Summary

The purpose of this study is to determine the feasibility of conducting a longitudinal cohort study at Sir Charles Gairdner Hospital (SCGH) to assess functional outcomes of persons with above-knee amputation with different prosthesis types. Each participant will undergo one assessment which will include a functional gait assessment, completion of questionnaires to measure balance confidence and quality of life, and a balance assessment using the SMART EquiTest system. It is hypothesised that it will be feasible to conduct a longitudinal cohort study at SCGH.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

People who have had a leg amputated above the knee rely on prosthetic limbs to walk and stay active. There are two main ways to attach a prosthetic leg: the traditional socket method, where the residual limb fits into a fitted cup, and osseointegration, a newer surgical technique where the prosthesis is connected directly to a metal implant in the thighbone. Both have potential advantages, but detailed comparisons of how they affect balance, walking ability, and quality of life are limited. This feasibility study at Sir Charles Gairdner Hospital brings together people with above-knee amputations fitted with either type of prosthesis for a single assessment session. The session includes a walking test, balance testing on a specialised computerised platform, and questionnaires about confidence and quality of life. The data will be used to plan a larger, longer-term study. You may be eligible if you are over 18 years old, have a unilateral above-knee amputation, have been using your prosthesis for at least 12 months, can stand and walk independently, and weigh less than 136 kg. People with active infections, recent stroke, or who are unable to communicate in English are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Each participant will undergo one assessment of approximately 90 minutes duration. All assessments will be conducted at the Perron Institute, RR Block, QE II Medical Centre, 8 Verdun St, Nedlands, WA.

Each participant will undergo one assessment of approximately 90 minutes duration. All assessments will be conducted at the Perron Institute, RR Block, QE II Medical Centre, 8 Verdun St, Nedlands, WA. All assessments will be conducted by the study investigator (physiotherapy Honours student) with supervision from a qualified physiotherapist. The assessment will comprise three parts. First, participants will be asked to carry out the timed up and go (TUG) test. The TUG test incorporates many components of basic mobility, including walking, turning, transfers, and balance. The TUG test is conducted by recording time (seconds) for the participant to stand from a seated position, walk three metres, turn around, walk back to the chair, and sit down. The TUG has been shown to have good intra-rater and inter-rater reliability and shows concurrent validity when used in unilateral lower-limb amputation populations. Secondly, participants will complete two questionnaires. Activities-specific Balance Confidence scale (ABC-UK) to obtain balance confidence measures. The ABC-UK is a 16-item self-report questionnaire, designed to determine balance confidence levels and associated fear of falling. Participants are asked to rate their level of confidence performing various activities (0-100%). Responses are added together and divided by 16 to give an overall mean balance confidence score. The ABC-UK has been shown to be a suitable tool for detecting loss of balance confidence, is internally consistent, with good test re-test reliability. Questionnaire for persons with a Transfemoral Amputation (Q-TFA) to obtain Quality of Life measures. The Q-TFA is a self-report questionnaire, with four sub-sections; current prosthetic use, prosthetic mobility, problems related to the prosthesis, and overall global health. Sub-sections are scored between 0-100 points, and a calculation (using sub-section scores) determines final Q-TFA score. This tool has been shown to have adequate test-retest reliability, clinical sensibility, criterion validity and internal consistency. Thirdly, participants will undergo balance assessment. Balance measures will be obtained using NeuroCom Balance Manager Dynamic System, SMART EquiTest model, a balance assessment tool which uses Computerised Dynamic Posturography (CDP) to quantify impairments underlying balance problems. CDP has been used in a previous study assessing persons with below-knee amputation. The SMART EquiTest testing functions to be used in this study include sensory organisation test (SOT), motor control test (MCT), and unilateral stance test (UST). SOT identifies the contribution of individual sensory system input cues used to maintain balance control. There are six test conditions; 1) eyes open, fixed surface; 2) eyes closed, fixed surface; 3) sway referenced visual surround, fixed surface; 4) eyes open, sway referenced surface; 5) eyes closed, sway referenced surface; 6) sway referenced visual surround, sway referenced surface. Raw data provides information on amplitude, direction, frequency, and regularity of anterior/posterior sway. MCT measures reactions to rapid translation of the support surface. Raw data provides information on response latency and weight symmetry. UST measures single limb stance ability and associated postural adjustments. Immediately following assessment, participants will have the opportunity to complete a short paper-based feedback survey to identify any problems encountered being involved in this study from their perspective, with an opportunity for participants to provide suggestions to improve the process. Participants can also opt to complete this feedback survey via email. If the participant chooses to receive the feedback in email format, this email will be sent on the same day of testing by the study investigator.


Locations(1)

Sir Charles Gairdner Hospital - Nedlands

WA, Australia

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