Trial registered on ANZCTR


Trial ID
ACTRN12605000173695
Ethics application status
Approved
Date submitted
18/08/2005
Date registered
18/08/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prosthetic evaluation program
Scientific title
Evaluation of an interdisciplinary assessment service to evaluate new prosthetic prescriptions for trauma related trans-femoral amputees
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trans-femoral amputation 268 0
Condition category
Condition code
Other 303 303 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will utilise a pre-post design where each participant will be evaluated firstly with their existing prosthesis and then again with the microprocessor controlled componentry. Each participant will be assessed at an interdisciplinary clinic and goals established with them. During this assessment they will see a rehabilitation specialist, a physiotherapist, and a prosthetist. Where appropriate a psychologist, orthopaedic specialist and pain specialist will be available.
Intervention code [1] 207 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 356 0
Ambulation using The StepWatch step activity monitor
Timepoint [1] 356 0
Measured for two weeks at baseline to evaluate current prosthesis and two weeks after fitting the microprocessor controlled componentry and completing appropriate training to evaluate the microprocessor controlled componentry.
Secondary outcome [1] 795 0
The 2-minute walk test
Timepoint [1] 795 0
All outcomes are administered on week two to evaluate current prosthesis and week seven (four weeks after fitting the microprocessor controlled componentry and appropriate training) to evaluate the microprocessor controlled componentry.
Secondary outcome [2] 796 0
The Hills Assessment Index
Timepoint [2] 796 0
All outcomes are administered on week two to evaluate current prosthesis and week seven (four weeks after fitting the microprocessor controlled componentry and appropriate training) to evaluate the microprocessor controlled componentry.
Secondary outcome [3] 797 0
The Stair Assessment Index
Timepoint [3] 797 0
All outcomes are administered on week two to evaluate current prosthesis and week seven (four weeks after fitting the microprocessor controlled componentry and appropriate training) to evaluate the microprocessor controlled componentry.
Secondary outcome [4] 798 0
An Obstacle Course (in house design, Video Analysis of Gait, Mental energy of walking (in house design)
Timepoint [4] 798 0
All outcomes are administered on week two to evaluate current prosthesis and week seven (four weeks after fitting the microprocessor controlled componentry and appropriate training) to evaluate the microprocessor controlled componentry.
Secondary outcome [5] 799 0
Physiological Cost Index
Timepoint [5] 799 0
All outcomes are administered on week two to evaluate current prosthesis and week seven (four weeks after fitting the microprocessor controlled componentry and appropriate training) to evaluate the microprocessor controlled componentry.
Secondary outcome [6] 800 0
Functional Capacity Evaluation by Ergo-Science
Timepoint [6] 800 0
All outcomes are administered on week two to evaluate current prosthesis and week seven (four weeks after fitting the microprocessor controlled componentry and appropriate training) to evaluate the microprocessor controlled componentry.
Secondary outcome [7] 801 0
Locomotor Capabilities Index
Timepoint [7] 801 0
All outcomes are administered on week two to evaluate current prosthesis and week seven (four weeks after fitting the microprocessor controlled componentry and appropriate training) to evaluate the microprocessor controlled componentry.
Secondary outcome [8] 802 0
Amputee Activity Score (modified)
Timepoint [8] 802 0
All outcomes are administered on week two to evaluate current prosthesis and week seven (four weeks after fitting the microprocessor controlled componentry and appropriate training) to evaluate the microprocessor controlled componentry.
Secondary outcome [9] 803 0
The Prosthesis Evaluation Questionnaire
Timepoint [9] 803 0
All outcomes are administered on week two to evaluate current prosthesis and week seven (four weeks after fitting the microprocessor controlled componentry and appropriate training) to evaluate the microprocessor controlled componentry.
Secondary outcome [10] 804 0
Trinity Amputation and Prosthesis Experience Scales - Section 1, Activities-Specific Balance Confidence Scale, Adult self-perception Profile.
Timepoint [10] 804 0
All outcomes are administered on week two to evaluate current prosthesis and week seven (four weeks after fitting the microprocessor controlled componentry and appropriate training) to evaluate the microprocessor controlled componentry.

Eligibility
Key inclusion criteria
Have had a trans-femoral amputation > 4 months previously,have a comfortable, well fitting prosthesis,can ambulate well on their current componentry but have been identified as possibly benefiting from a microprocessor knee unit.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with an ill-fitting prosthetic socket that is likely to require adjustment over the next 8 weeks,individuals who will not be able to complete all eight clinical assessment tests within a maximum of two testing sessions,individuals who have a recent injury that is affecting their usual gait pattern, individuals who can not commit to a consecutive 8 week time frame.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 359 0
Self funded/Unfunded
Name [1] 359 0
Address [1] 359 0
Country [1] 359 0
Primary sponsor type
Individual
Name
Professor Maria Crotty
Address
Country
Secondary sponsor category [1] 285 0
None
Name [1] 285 0
None
Address [1] 285 0
Country [1] 285 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1332 0
Repatriation General Hospital
Ethics committee address [1] 1332 0
Ethics committee country [1] 1332 0
Australia
Date submitted for ethics approval [1] 1332 0
Approval date [1] 1332 0
Ethics approval number [1] 1332 0

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

Contacts
Principal investigator
Name 35265 0
Address 35265 0
Country 35265 0
Phone 35265 0
Fax 35265 0
Email 35265 0
Contact person for public queries
Name 9396 0
Prof. Maria Crotty
Address 9396 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 9396 0
Australia
Phone 9396 0
+61 8 82751103
Fax 9396 0
+61 8 82751130
Email 9396 0
maria.crotty@rgh.sa.gov.au
Contact person for scientific queries
Name 324 0
Prof. Maria Crotty
Address 324 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 324 0
Australia
Phone 324 0
+61 8 82751103
Fax 324 0
+61 8 82751130
Email 324 0
maria.crotty@rgh.sa.gov.au