Effect of Two Types of Shoe Insole and Exercise Program on the Dynamics of Lower Extremities Joints in the Disabled with Leg Limb Length Discrepancy during Stance Phase of Walking
Effect of Two Types of Shoe Insole and Exercise Program on the Dynamics of Lower Extremities Joints in the Disabled with Leg Limb Length Discrepancy during Stance Phase of Walking
Design
This study is a clinical trial with a control group, parallel groups, non-blinded, randomized groups by number assignment to participants and a draw and 30 samples (10 individuals in each group).
Settings and conduct
The place of this study is the University of Mazandaran. The test is recorded in three conditions: with shoes, Internal insole and external insole for all subjects. They begin their movement from four meters of the force plate and by getting a controlled rhythm, the average of three successful attempts is recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Difference in the length of lower limb is between one to two and a half centimeters
Full ability to walk
age range between 45 and 65 years
No balance problems
Exit criteria:
Having a history of a lower limb rehab program six months before the test
Having a history of using the therapeutic shoe insoles six months before the test
Having a history of lower limb joints fracture or surgery six months before the test
Systemic diseases such as rheumatism and diabetes
Intervention groups
1. Internal insoles. They used an Internal insole for 12 weeks. This insole is equal to the difference in the length of the limb of each subject and is slop in the heel area.
2. External insoles. They used an external insole in the under-shoe area for 12 weeks. This insole is equal to the difference in the length of the limb of each subject in the heel to toe section and is not sloping.
3. Exercise Group. Strengthening and Stretching exercises of the Lumbar and pelvis were performed for 12 weeks.
Main outcome variables
Dynamics of Lower Extremities Joints
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190718044261N1
Registration date:2019-10-11, 1398/07/19
Registration timing:retrospective
Last update:2019-10-11, 1398/07/19
Update count:0
Registration date
2019-10-11, 1398/07/19
Registrant information
Name
Mansour Eslami
Name of organization / entity
The University of Mazandaran
Country
Iran (Islamic Republic of)
Phone
+98 11 3530 2210
Email address
fr.habibi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-12-06, 1397/09/15
Actual recruitment start date
2018-11-21, 1397/08/30
Actual recruitment end date
2019-03-11, 1397/12/20
Trial completion date
2019-03-16, 1397/12/25
Scientific title
Effect of Two Types of Shoe Insole and Exercise Program on the Dynamics of Lower Extremities Joints in the Disabled with Leg Limb Length Discrepancy during Stance Phase of Walking
Public title
Effect of foot insoles and exercise program on subjects with Leg Length Discrepancy (LLD)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The difference in length of the lower limb is between one to two and a half centimeters
Full ability to walk
Age range between 45 and 65 years
No balance problems
Exclusion criteria:
Having a history of lower limb rehab program six months before the test
Having a history of using the therapeutic shoe insoles six months before the test
Having a history of lower limb joints fracture or surgery six months before the test
Systemic diseases such as rheumatism and diabetes
Age
From 45 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Actual sample size reached:
29
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, all participants in the study were assigned a number, and then they were selected using the lottery for each group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Mazandaran
Street address
Shahid Beheshti Ave, University of Mazandaran, Faculty of Physical Education and Sport Sciences
City
Babolsar
Province
Mazandaran
Postal code
4741613534
Approval date
2019-03-06, 1397/12/15
Ethics committee reference number
IR.UMZ.REC.1397.050
Health conditions studied
1
Description of health condition studied
Leg Limb Length Discrepancy
ICD-10 code
M21.7
ICD-10 code description
Unequal limb length (acquired)
Primary outcomes
1
Description
Dynamics of Lower Extremities Joints
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
General Health Questionnaire of Subjects, meter, and Scale to measure anthropocentric characteristics, Force plate, Camera and Marker to Record Motion and Calculate Dynamics of Lower Extremities Joints
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: The intervention in this group involves the use of internal insole for Shortness of leg compensation for twelve weeks. The height of the insole in the heel area is equal to the length difference of two legs and does not have a high in the toe area and made of a semi-rigid material.
Category
Prevention
2
Description
Second Intervention group: The intervention in this group involves the use of external insole for shortness of leg compensation for twelve weeks. The height of the insole in the heel to toe area is equal to the length difference of two legs and made of a semi-rigid material.
Category
Prevention
3
Description
Third intervention group: The intervention in this group involves the use of exercise for twelve weeks. In subjects with short leg limbs due to lateral pelvic tilt, weakness hip abductors, shortness of iliopsoas muscle, muscle weakness lumbar muscles and the shorten of Plantar flexor muscles in short leg, exercise program with an emphasis on weakened muscle strength and stretch the muscles shortened.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Health Assessment and Monitoring, Faculty of Physical Education and Sports Sciences, Univ
Full name of responsible person
Mansour Eslami
Street address
Shahid Beheshti Ave, Mazandaran University, Faculty of Physical Education and Sport Sciences