The objective of this study was to compare the effects of the two different prosthetic suspension systems namely: Seal-In Liner and Dermo Liner (both are considered silicone liners) on lower limb amputee's gait performance and satisfaction. This study aims to:
To obtain kinematics and kinetics of trans-tibial amputees gait using locking liner and Seal-in liner by using motion analysis approach.
To evaluate the biomechanical characteristics of each of the suspension systems (locking and seal-in) in terms of comfort, function and satisfaction in traumatic or diabetics amputees.
15 unilateral transtibial amputees were found eligible to participate in this study. Ethical approval was obtained from the University of Malaya Medical Centre Ethics Committee. All the subjects were required to sign a written consent form.
The inclusion criteria for the study consisted of unilateral transtibial amputation, walking without walking aids, steady limb volume during the previous year, pain- and ulcer-free stump, and stump length of more than 11 cm. The latter was considered optimal for use of the Seal-In transtibial liner, as stated by the manufacture. A single registered prosthetist designed and aligned two transtibial prostheses for each subject to prevent any bias in the results. Only the suspension systems were different while all other components including feet were similar for both prostheses. A four-week acclimation period was allocated for each prosthetic leg. Following this, each subject completed five gait trials at a self-selected pace for each suspension system.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012816395N1
Registration date:2014-02-16, 1392/11/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-16, 1392/11/27
Registrant information
Name
Hossein Gholizadeh
Name of organization / entity
University of Malaya
Country
Malaysia
Phone
060172763238
Email address
gholizadeh@um.edu.my
Recruitment status
Recruitment complete
Funding source
This study was supported by Malaysia UM/MOHE/HIR (project number: D000014-16001). The prosthetic components were donated by Össur (Reykjavik, Iceland).
Expected recruitment start date
2011-01-01, 1389/10/11
Expected recruitment end date
2013-01-01, 1391/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of two different prosthetic suspension systems on lower limb amputee's gait performance and satisfaction.
Public title
prosthetic suspension system
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria for the study consisted of person with trans-tibial amputation, walking without walking aids, steady limb volume during the previous year, pain- and ulcer-free stump, and stump length of more than 11 cm.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
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
University of Malaya Medical Centre Ethics Committee
Street address
Lembah Pantai, Kuala Lumpur, Malaysia, 59100
City
Kuala Lumpur
Postal code
59100
Approval date
2010-07-27, 1389/05/05
Ethics committee reference number
799.7
Health conditions studied
1
Description of health condition studied
Lower limb amputation
ICD-10 code
S88.1
ICD-10 code description
Amputation at level between knee and ankle
Primary outcomes
1
Description
Ambulation
Timepoint
4 weeks after use
Method of measurement
kinematic & kinetic gait analysis
Secondary outcomes
1
Description
Interface pressure
Timepoint
4 weeks after use
Method of measurement
Pressure mapping
Intervention groups
1
Description
Transtibial prosthetic suspension system (Dermo liner with pin lock )
Category
Rehabilitation
2
Description
Transtibial prosthetic suspension system (Seal-in liner with valve)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Malaya (Hospital)
Full name of responsible person
Street address
City
Kuala Lumpur
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
UM/MOHE/HIR grant (project no: D000014-16001)
Full name of responsible person
Prof. Dr. Noor Azuan Abu Osman
Street address
Deputy Dean office, Faculty of Engineering, Kuala Lumpur, Malaysia, 50603
City
Kuala Lumpur
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
UM/MOHE/HIR grant (project no: D000014-16001)
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Biomedical Engineering, Faculty of Engineering, University of Malaya, Kuala Lumpur, Ma
Full name of responsible person
Prof.Noor Azuan Abu Osman
Position
Professor
Other areas of specialty/work
Street address
Faculty of Engineering, Kuala Lumpur, Malaysia, 50603