Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000512729
Ethics application status
Approved
Date submitted
19/03/2022
Date registered
31/03/2022
Date last updated
31/03/2022
Date data sharing statement initially provided
31/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Functional outcomes for persons with above knee amputation fitted with different prosthesis types.
Scientific title
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.
Secondary ID [1] 306720 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
above knee amputation 325699 0
osseointegration 325700 0
Condition category
Condition code
Physical Medicine / Rehabilitation 323049 323049 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 323205 0
Diagnosis / Prognosis
Comparator / control treatment
Those participants with above-knee amputation fitted with a conventional socket type prosthesis will form the comparator group.
Control group
Active

Outcomes
Primary outcome [1] 330808 0
Proportion of eligible population recruited.
Potential participants eligible for this study will be identified by a search of the North Metropolitan Amputee Service database, and will include both previous patients to the service, and patients currently undergoing rehabilitation. The proportion of eligible population recruited will be determined by an audit of the above mentioned database. Those who are recruited to the study will be expressed as a percentage of this eligible population.
Timepoint [1] 330808 0
To be assessed at the end of recruitment phase
Primary outcome [2] 330809 0
Withdrawal rate of participants.
Upon recruitment to the study, participants will be added to a database which will tally the number of participants recruited in total. The number of participants following completion of recruitment will be compared to the number of participants who complete the study. The withdrawal rate of participants will be determined by the number of participants who didn't complete the study compared to the total number who were recruited. This will be expressed as a percentage of those recruited to the study.
Timepoint [2] 330809 0
Cumulative data to be assessed at the conclusion of the study
Primary outcome [3] 330810 0
Time taken per participant.
A log will be kept of all time spent by researchers for each participant throughout the study. This will include recruitment, assessment/data collection, and any follow up. Time will be collected using a digital stopwatch and will be self-reported by the research team member involved. Each time report will be logged onto the data collection spreadsheet. Following conclusion of the study, time spent for each participant will be calculated by addition of all time reports in the database.
As a feasibility study, it is important to understand the time commitments required for any future longitudinal study so it could be staffed appropriately.
Timepoint [3] 330810 0
Cumulative data to be assessed at the conclusion of the study
Secondary outcome [1] 407638 0
Functional gait measures will be obtained using a Timed Up and Go (TUG) test.
Timepoint [1] 407638 0
Cumulative data to be assessed at the conclusion of the study
Secondary outcome [2] 407639 0
Quality of life (QOL) measures will be obtained using the Questionnaire for persons with a Transfemoral Amputation (Q-TFA).
Timepoint [2] 407639 0
Cumulative data to be assessed at the conclusion of the study
Secondary outcome [3] 407640 0
Balance confidence measures will be obtained using the Activities-specific Balance Confidence scale (ABC-UK).
Timepoint [3] 407640 0
Cumulative data to be assessed at the conclusion of the study
Secondary outcome [4] 407641 0
Balance measures will be obtained using SMART EquiTest sensory organisation test (SOT). SOT identifies the contribution of individual sensory system input cues used to maintain balance control. Raw data provides information on amplitude, direction, frequency, and regularity of anterior/posterior sway.
Timepoint [4] 407641 0
Cumulative data to be assessed at the conclusion of the study
Secondary outcome [5] 407893 0
Balance measures will be obtained using SMART EquiTest motor control test (MCT). MCT measures reactions to rapid translation of the support surface. Raw data provides information on response latency and weight symmetry.
Timepoint [5] 407893 0
Cumulative data to be assessed at the conclusion of the study
Secondary outcome [6] 407894 0
Balance measures will be obtained using SMART EquiTest unilateral stance test (UST). UST measures single limb stance ability and associated postural adjustments.
Timepoint [6] 407894 0
Cumulative data to be assessed at the conclusion of the study

Eligibility
Key inclusion criteria
For inclusion in this study, participants must meet the criteria listed below:
- Unilateral above-knee amputation
- At least 12 months post amputation
- Fitted with full-length prosthesis (either osseointegrated or socket)
- Ability to stand independently
- Ability to walk and step up one step with minimal assistance (with or without aid)
- Meet essential selection criteria for osseointegration regardless of prosthesis type fitted:
o Over 18yrs and Australian Permanent residency status
o No diabetic or vascular pathology
o Body Weight < 100kg
o Adequate bone maturity and density
o Cognitively, physically, and medically suitable for surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from this study if they are unable to understand written or spoken English, or have a cognitive impairment that would impact on their ability to follow instructions. Participants with active infection, active vestibular disorder, historical stroke, or ongoing chemotherapy treatment will be excluded. Pregnant women will also be excluded to mitigate additional falls risk. Participants will be excluded if their weight exceeds 136kg or height exceeds 203cm due to limitations of the SMART EquiTest equipment.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analysis for this study will be descriptive in nature, likely to involve count, frequency and proportion. Descriptive summaries of patient demographics and clinical characteristics will include frequency distributions for categorical data and non-parametric medians and interquartile ranges for continuous data, as sample size will be small.

Primary outcomes will be analysed by the following means:
1 – proportion of eligible population recruited (percentage)
2 – withdrawal rate of participants (percentage)
3 – time taken for data collection (count)
4 – sample size calculations for a future longitudinal study
Descriptive statistics will be provided for each group and for the overall sample.

Secondary Outcomes will be analysed by the following means:
Gait – TUG score (median)
Quality of Life – Q-TFA score
Balance confidence – ABC-UK score
Balance – rate/attempts/completion of tests, SOT, MCT, UST scores
Secondary outcome statistics will be provided for each group. Comparative analysis of the two groups will not be performed.

Data analysis will be conducted using SPSS statistical analysis software (version 22.0, SPSS, Chicago, IL, USA).
This data will be presented in the form of a report to SCGH and Curtin University stakeholders, as well as hopefully reported in a peer-reviewed journal.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/03/2022
Date of last participant enrolment
Anticipated
10/06/2022
Actual
Date of last data collection
Anticipated
10/06/2022
Actual
Sample size
Target
20
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 21991 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 37092 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 311047 0
University
Name [1] 311047 0
Curtin University
Country [1] 311047 0
Australia
Funding source category [2] 311048 0
Hospital
Name [2] 311048 0
Sir Charles Gairdner Hospital
Country [2] 311048 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street
Bentley
WA
6102
Country
Australia
Secondary sponsor category [1] 312379 0
Hospital
Name [1] 312379 0
Sir Charles Gairdner Hospital
Address [1] 312379 0
Hospital Ave,
Nedlands WA 6009
Country [1] 312379 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310595 0
Sir Charles Gairdner Osborne Park Health Care Group HREC
Ethics committee address [1] 310595 0
Ethics committee country [1] 310595 0
Australia
Date submitted for ethics approval [1] 310595 0
22/02/2022
Approval date [1] 310595 0
28/02/2022
Ethics approval number [1] 310595 0
RGS0000004877
Ethics committee name [2] 310598 0
Curtin University
Ethics committee address [2] 310598 0
Ethics committee country [2] 310598 0
Australia
Date submitted for ethics approval [2] 310598 0
07/03/2022
Approval date [2] 310598 0
09/03/2022
Ethics approval number [2] 310598 0
HREC2022-0120

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118206 0
Ms Andrea Becker
Address 118206 0
Curtin University
Kent Street
Bentley
WA
6102
Country 118206 0
Australia
Phone 118206 0
+61474840138
Fax 118206 0
Email 118206 0
[email protected]
Contact person for public queries
Name 118207 0
Andrea Becker
Address 118207 0
Curtin University
Kent Street
Bentley
WA
6102
Country 118207 0
Australia
Phone 118207 0
+610892669228
Fax 118207 0
Email 118207 0
[email protected]
Contact person for scientific queries
Name 118208 0
Andrea Becker
Address 118208 0
Curtin University
Kent Street
Bentley
WA
6102
Country 118208 0
Australia
Phone 118208 0
+610892669228
Fax 118208 0
Email 118208 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data of all outcomes collected will be available for sharing on request.
When will data be available (start and end dates)?
Data will be available for 7 years after publication.
Available to whom?
De-identified data will be provided upon request
Available for what types of analyses?
De-identified data will be provided on request for any purposes
How or where can data be obtained?
De-identified data will be provided on request from Principal Investigator, Andrea Becker [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15461Study protocol  [email protected]
15462Clinical study report  [email protected]
15463Ethical approval  [email protected]
15464Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.