The aims of this study are to determine and comparison of gait kinematic, postural stability and socket comfort in transfemoral amputees using quadrilateral socket and Modified socket with new Casting System.
Design
In this study three transfemoral amputees who meet all the inclusion/exclusion criteria will participate.
Settings and conduct
The aims of this study are to evaluate gait kinematics and postural stability in transfemoral amputees with two types of sockets. For each participant a modified Sockets will fabricate by a dynamic casting system. Postural stability and gait kinematic will investigate within the four consecutive weeks and in two conditions: with quadrilateral socket and with modified socket.
Data recording will be by motion analysis system and force plate ِduring walking and standing respectively. All assessments will conduct at motion analysis laboratory of the School of Rehabilitation Sciences of Iran Medical Science University.
Participants/Inclusion and exclusion criteria
Unilateral transfemoral amputees; ages between 18 and 50 years who use of quadrilateral Socket for at least two years, without history of diabetes, Cardiovascular disease or Neurological disorders .
Intervention groups
1- Prostheses with quadrilateral socket 2- Prostheses with modified socket
Main outcome variables
Gait kinematics and postural stability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181021041400N1
Registration date:2019-04-18, 1398/01/29
Registration timing:prospective
Last update:2019-04-18, 1398/01/29
Update count:0
Registration date
2019-04-18, 1398/01/29
Registrant information
Name
Behnam Hajiaghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
hajiaghaei.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-05-20, 1398/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Gait Biomechanics and Postural Stability in Transfemoral Amputees using Modified Socket with New Casting System and Quadrilateral Socket
Public title
Effects of Sockets on Amputees' gait and Stability.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral Transfemoral Amputee
Ages: 18-50 years
Long or Middle length Residual Limb
10 Meter Walking Ability without Assistive Device.
Using Quadi-Lateral Socket
Using Prosthesis more than 2 Years.
Exclusion criteria:
Diabetes or vascular disease
Orthopedics Problem that Impact on Walking.
Amputation in another limbs
Neurological Disease
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
3
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
Next to the Milad Tower; Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.IUMS.REC.1397.448
Health conditions studied
1
Description of health condition studied
transfemoral amputation
ICD-10 code
S78.1
ICD-10 code description
Traumatic amputation at level between hip and knee
Primary outcomes
1
Description
Velocity
Timepoint
Before Intervention and 7, 14 and 21 days after Intervention
Method of measurement
Motion Analysis System
2
Description
Postural Stability
Timepoint
Before Intervention and 7, 14 and 21 days after Intervention