Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001757808
Ethics application status
Approved
Date submitted
28/07/2020
Date registered
22/12/2021
Date last updated
22/12/2021
Date data sharing statement initially provided
22/12/2021
Date results provided
22/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Symmetry of gait in transfemoral amputees.
Scientific title
Clinical, biomechanical adaptation of people after unilateral transfemoral amputation or amelia of the lower limb to gait using advanced prosthetic solutions - a prospective, single-center, clinical, controlled, observational study.
Secondary ID [1] 301505 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic amputation at the thigh level 318382 0
Vascular amputation at thigh level 318383 0
Congenital defect of the lower limb 318384 0
Cancer-related amputation 318385 0
Condition category
Condition code
Physical Medicine / Rehabilitation 316401 316401 0 0
Physiotherapy
Musculoskeletal 316402 316402 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The bomechanical study will include unilateral tranfemoral amputation patients (UniTransFemorLimLos), who will constitute Group I. Group II will consist of age-matched healthy volunteers. The methodology and parameters of the biomechanical study will be established according to the literature on biomechanical testing. The study will be performed in a certified Biomechanical Analysis Laboratory (PN-EN ISO 9001:2001) using the BTS Smart-E system (BTS Bioengineering, Milan, Italy), which uses six digital infrared cameras (1. 1 µm infrared light, 120 frames per second at 768 x 576 px resolution), two AXIS 210A Network Cams operating in the visible range at 20 Hz and two piezoelectric force plates type 9286A (Kistler Instrumente AG, Winterthur) specifically designed for use in gait analysis with a measurement threshold above 250 mN and a range of 0-5 kN for the vertical component. Data were collected via a digital USB/PC input and processed in the BTS Smart Analyser software. A total of 22 photoreflective markers were placed on the subject's body, following the standard procedure for the Davis model. Hip flexion (FL) and extension (EXT) musculoskeletal speed and endurance abilities were measured using a Biodex System 4 Pro device. All measurements were performed in the sagittal plane under isokinetic (60°/s and 120°/s angular velocity) and isometric conditions. The following variables were studied: peak torque for FL and EXT under isometric conditions, peak torque for FL and EXT under isokinetic conditions. The torque ratio FL to EXT (F/E ratio) was calculated for the intact and amputated limb. The test is carried out on a one-off basis. The duration of the test is approximately 1.5 h. During the test subjects will be asked to walk a distance of 6 m several times (5 back and forth) in a prosthesis at a freely chosen gait speed.
Intervention code [1] 318184 0
Not applicable
Comparator / control treatment
Observational study. Comparison is being made between patients with lower limb amputation wearing a prosthesis and healthy, age-matched volunteers.
Control group
Active

Outcomes
Primary outcome [1] 324569 0
Firrs primary outcome is a clinical observation of walking for people after UniTransFemorLimLos. For each participant and each of the measured cycles, time normalization of the right and
left angles for the sagittal plane or GRF components was performed numerically, utilizing decomposition of a time series (trend detection) using the Lagrange interpolation polynomial (MATLAB script). In this way, right and left cycles of the same length (100% Cycle Time (CT) for angles and 100% Stance Time (ST) for GRF components) with discrete values (every 0.5%) were obtained. Gait symmetry was evaluated based on the vertical ground reaction force (vGRF) and the anterior-posterior (a-p GRF) ground reaction force.
Timepoint [1] 324569 0
Immediately following the test/
Primary outcome [2] 328501 0
Vertical ground reaction force by means of 2 Kistler 9286A dynamometer platforms running at 1000 Hz.
Timepoint [2] 328501 0
During single assessment session.
Primary outcome [3] 328502 0
Anterior-posterior ground reaction force by means of 2 Kistler 9286A dynamometer platforms running at 1000 Hz.
Timepoint [3] 328502 0
During single assessment session
Secondary outcome [1] 384998 0
Biomechanical assessment of muscle torque:
Hip extensor muscle torque measured in Nm.
Timepoint [1] 384998 0
During single assessment session
Secondary outcome [2] 403305 0
Biomechanical assessment of muscle torque:
Hip flexor muscle torque measured with Nm.
Timepoint [2] 403305 0
During single assessment session
Secondary outcome [3] 403764 0
Biomechanical assessment of muscle torque:
Hip extensor muscle torque measured with %BW (Body Weight).
Timepoint [3] 403764 0
During single assessment session
Secondary outcome [4] 403765 0
Biomechanical assessment of muscle torque:
Hip flexor muscle torque measured with %BW (Body Weight).
Timepoint [4] 403765 0
During single assessment session
Secondary outcome [5] 403766 0
We measured time series of variables characterizing motion of the pelvis and major joints of the lower extremities. Following the ISB recommendations for joint coordinate system definitions, the following angles, sampled at 120 Hz and normalized to cycle time (%CT), were selected:pelvic obliquity: upward (positive) or downward (negative) movement of the pelvis in the frontal plane

Timepoint [5] 403766 0
During single assessment session
Secondary outcome [6] 403767 0
We measured time series of variables characterizing motion of the pelvis and major joints of the lower extremities. Following the ISB recommendations for joint coordinate system definitions, the following angles, sampled at 120 Hz and normalized to cycle time (%CT), were selected:pelvic tilt: forward (positive) or backward (negative) movement of the pelvis in the sagittal plane;
For these data we calculated: Peak min, t min, Peak max, t max, ROM
Timepoint [6] 403767 0
During single assessment session
Secondary outcome [7] 403768 0
We measured time series of variables characterizing motion of the pelvis and major joints of the lower extremities. Following the ISB recommendations for joint coordinate system definitions, the following angles, sampled at 120 Hz and normalized to cycle time (%CT), were selected:pelvic rotation: internal (positive) or external (negative) movement of the pelvis in the transverse plane;
For these data we calculated: Peak min, t min, Peak max, t max, ROM
Timepoint [7] 403768 0
During single assessment session
Secondary outcome [8] 403769 0
We measured time series of variables characterizing motion of the pelvis and major joints of the lower extremities. Following the ISB recommendations for joint coordinate system definitions, the following angles, sampled at 120 Hz and normalized to cycle time (%CT), were selected:hip adduction/adduction: adduction (positive) or adduction (negative) of the femur in the frontal plane;
For these data we calculated: Peak min, t min, Peak max, t max, ROM
Timepoint [8] 403769 0
During single assessment session
Secondary outcome [9] 403770 0
We measured time series of variables characterizing motion of the pelvis and major joints of the lower extremities. Following the ISB recommendations for joint coordinate system definitions, the following angles, sampled at 120 Hz and normalized to cycle time (%CT), were selected:hip flexion-extension: flexion (positive) or extension (negative) of the femur in the sagittal plane;
For these data we calculated: Peak min, t min, Peak max, t max, ROM
Timepoint [9] 403770 0
During single assessment session
Secondary outcome [10] 403771 0
We measured time series of variables characterizing motion of the pelvis and major joints of the lower extremities. Following the ISB recommendations for joint coordinate system definitions, the following angles, sampled at 120 Hz and normalized to cycle time (%CT), were selected:hip rotation: internal (positive) or external (negative) movement of the femur in the transverse plane;
For these data we calculated: Peak min, t min, Peak max, t max, ROM
Timepoint [10] 403771 0
During single assessment session
Secondary outcome [11] 403772 0

We measured time series of variables characterizing motion of the pelvis and major joints of the lower extremities. Following the ISB recommendations for joint coordinate system definitions, the following angles, sampled at 120 Hz and normalized to cycle time (%CT), were selected:knee flexion-extension: femoral flexion (positive) or extension (negative) in the sagittal plane;
For these data we calculated: Peak min, t min, Peak max, t max, ROM
Timepoint [11] 403772 0
During single assessment session
Secondary outcome [12] 403773 0
We measured time series of variables characterizing motion of the pelvis and major joints of the lower extremities. Following the ISB recommendations for joint coordinate system definitions, the following angles, sampled at 120 Hz and normalized to cycle time (%CT), were selected:ankle flexion-extension: dorsal (positive) or longitudinal (negative) movement of the foot in the sagittal plane of the foot;
For these data we calculated: Peak min, t min, Peak max, t max, ROM
Timepoint [12] 403773 0
During single assessment session
Secondary outcome [13] 403774 0
We measured time series of variables characterizing motion of the pelvis and major joints of the lower extremities. Following the ISB recommendations for joint coordinate system definitions, the following angles, sampled at 120 Hz and normalized to cycle time (%CT), were selected:and vertical, anteroposterior, and medial-lateral components of ground reaction force (GRF) as a function of standing time (%ST). GRF components were normalized to body weight and expressed as percentages (%BW).
For these data we calculated: Peak min, t min, Peak max, t max, ROM
Timepoint [13] 403774 0
During single assessment session

Eligibility
Key inclusion criteria
Inclusion criteria will include:
1. Loss of lower limb at the level of the thigh.
2. the use of a prosthetic limb in addition to daily living.
3. use of the currently used prosthesis for at least 6 months.
4.The ability to walk a distance of not less than 20 metres without the use of elbow crutches.
5.Congenital lower limb impingement consisting of absence of the knee joint and structures below.
6.Medicare Functional Classification K level 3 or 4.
7.Informed consent for the study.

Key inclusion criteria Healthy, age-matched volunteers: Inclusion criteria will include:
1. No history of musculoskeletal or nervous system disorders on the day of the study.
2. absence of cognitive impairment.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria will be pain in the stump or lower limbs and chronic diseases that could affect the fitness of the musculoskeletal system in terms of satiation:
1. Cancer relapse.
2. Injury to the locomotor system.
3. Exacerbation of thromboembolism (including the antiphospholipid syndrome).
4. Pain in the area of the lumbar spine.
5. Root pain in the course of discopathy.
6. Cognitive dysfunction

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Apart from the graphical results, the analysis of the distribution of all variables will be assessed with the Shapiro-Wilk test. Basic descriptive statistics (arithmetic means and standard deviations) were assessed for the separated values of Peak min, t min, Peak max, t max and range of motion (ROM). The non-parametric Mann-Whitney U test was used to test the differences between sides and events for different angle profiles and SF functions (p = 0.05).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2019
Date of last participant enrolment
Anticipated
Actual
31/10/2019
Date of last data collection
Anticipated
Actual
30/04/2020
Sample size
Target
40
Accrual to date
Final
34
Recruitment outside Australia
Country [1] 22794 0
Poland
State/province [1] 22794 0
Lower Silesia

Funding & Sponsors
Funding source category [1] 305945 0
University
Name [1] 305945 0
Wroclaw Medical University
Country [1] 305945 0
Poland
Primary sponsor type
University
Name
Wroclaw Medical University
Address
Wybrzeze L. Pasteura 1
50-367 Wroclaw
Country
Poland
Secondary sponsor category [1] 311311 0
None
Name [1] 311311 0
None
Address [1] 311311 0
None
Country [1] 311311 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306188 0
Bioethics Committee at the Medical University of Wroclaw
Ethics committee address [1] 306188 0
Ethics committee country [1] 306188 0
Poland
Date submitted for ethics approval [1] 306188 0
01/05/2012
Approval date [1] 306188 0
05/07/2012
Ethics approval number [1] 306188 0
KB-612/2012

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

Contacts
Principal investigator
Name 103022 0
Dr Mateusz Kowal
Address 103022 0
Department of Physiotherapy, Medical University of Wroclaw
Grunwaldzka Street 2
50-355 Wroclaw
Country 103022 0
Poland
Phone 103022 0
+48507197872
Fax 103022 0
Email 103022 0
[email protected]
Contact person for public queries
Name 103023 0
Mateusz Kowal
Address 103023 0
Department of Physiotherapy, Medical University of Wroclaw
Grunwaldzka Street 2
50-355 Wroclaw
Country 103023 0
Poland
Phone 103023 0
+48507197872
Fax 103023 0
Email 103023 0
[email protected]
Contact person for scientific queries
Name 103024 0
Mateusz Kowal
Address 103024 0
Department of Physiotherapy, Medical University of Wroclaw
Grunwaldzka Street 2
50-355 Wroclaw
Country 103024 0
Poland
Phone 103024 0
+48507197872
Fax 103024 0
Email 103024 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?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator (provide email: [email protected])


What supporting documents are/will be available?

No Supporting Document Provided



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.