Effect of microprocessor prosthetic ankle controlling via synergy movements idea on motor performance and postural adjustments in unilateral transtibial amputees.
Investigating the effect of using a new prosthetic ankle joint with the ability to automatically adjust the angle of the ankle joint based on the position of the trunk on the motor performance of unilateral below-the-knee amputees.
Design
A crossover clinical trial study with a control group of 5 healthy people and an intervention group of 5 people with unilateral below-the-knee amputations who will undergo three types of intervention and the test will be conducted as an ABC course.
Settings and conduct
First phase: design and manufacture of prosthetic ankle joint
Electromechanical ankle prosthetic joint that is designed and manufactured as a prototype in this study. It has an electric motor to move the ankle joint against the direction of the trunk.
Phase II: clinical evaluation of the constructed joint and examination of WBR movements
At this stage, WBR test will be taken from all people. The test is that the person bends forward until his hand reaches his knee, then he stands again.
The test will be done with 10 repetitions.
In the intervention group, the test will be performed with SACH foot, single axis and new joints.
Participants/Inclusion and exclusion criteria
middle stump lengths
trumatic amputees
Not using aids such as canes
Absence of orthopedic problems in other Limbs
Not having balance problems
Not having diabetes
Not be elderly
Spinal flexibility
Have at least five years of experience using prosthesis
Intervention groups
Intervention group is five transtibila amputees.
Effects of three types of interventions includes SACH foot, Single axis foot and newly designed ankle joint will be evaluated together.
Main outcome variables
Work done in Joules at the hip, knee and ankle joints
Hip, knee and ankle power in watts
Anterior-posterior displacement of the center of pressure
Angular changes in the hip, knee and ankle joints
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230609058434N1
Registration date:2023-06-13, 1402/03/23
Registration timing:prospective
Last update:2023-06-13, 1402/03/23
Update count:0
Registration date
2023-06-13, 1402/03/23
Registrant information
Name
Morteza Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7711 8523
Email address
mmto20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-15, 1402/03/25
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of microprocessor prosthetic ankle controlling via synergy movements idea on motor performance and postural adjustments in unilateral transtibial amputees.
Public title
Effect of prosthetic foot on balance
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Transtibial Amputees
Exclusion criteria:
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
No 47, shaghayegh building, shahrake beheshti, babayi highway
City
Tehran
Province
Tehran
Postal code
165113348
Approval date
2022-10-24, 1401/08/02
Ethics committee reference number
IR.IUMS.REC.1401.612
Health conditions studied
1
Description of health condition studied
unilateral transtibilal amputation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Work done on the hip, knee and ankle joints
Timepoint
10 repetitions after using the desired intervention
Method of measurement
Vicon Nexus motion capture platform
2
Description
The power of the hip, knee and ankle joints
Timepoint
10 repetitions after using the desired intervention
Method of measurement
Vicon Nexus motion capture platform
3
Description
Anterior-posterior displacement of the center of pressure
Timepoint
10 repetitions after using the desired intervention
Method of measurement
Vicon Nexus motion capture platform
4
Description
Angular changes of the hip, knee and ankle joints
Timepoint
10 repetitions after using the desired intervention
Method of measurement
Vicon Nexus motion capture platform
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The people of this group will receive three interventions and after receiving each intervention, the test will be done with 10 repetitions. Interventions will include the use of SACH foot, single axis foot and new ankle joint.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Orthotics and Prosthetics center
Full name of responsible person
Behnam hajiaghayi
Street address
Afshari street
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 2294 8007
Email
mmto20@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behnam hajiaghayi
Street address
shahnazari street
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 0947
Email
mmto20@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Morteza Mohammadi
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Others
Street address
No 47, shaghayegh bulding 13, Shahrake Beheshti, Babayi Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1651113348
Phone
+98 21 7711 8523
Fax
Email
mmto20@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behnam hajiaghyi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Shahnazari street
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 0947
Email
hajiaghaei.b@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Morteza Mohammadi
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Others
Street address
babayi highway
City
Tehran
Province
Tehran
Postal code
1651113348
Phone
+98 21 7711 8523
Email
mmto20@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The output files of Nexus Vicon program in c3d format
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Academic and industrial researchers
Under which criteria data/document could be used
In order to integrate with data from other studies to obtain more samples