Evaluation of the immediate effect of heel lift on mobility and functional balance in the elderly with leg length discrepancy after knee arthroplasty
Design
The study will be before after (single group) with and without heel lift on 20 elderly people
Settings and conduct
Balance and mobility in this study were measured by Timed up and go test and berg balance scale. Then, based on the shortness of limbs of the people present in the study, a suitable heel lift was prepared and placed in the shoes of the people and the tests were repeated.
This study was conducted in Ilam.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 60 years; Structural shortness of the lower extremities, More than 20 mm.
Non-inclusion criteria: history of fracture, orthopedic or neurological injury in the lower limb; Taking medications that have a significant effect on nervous system and balance.
Intervention groups
One intervention group: consists of people who use heel lifts for half an hour based on the shortness of their legs.
Main outcome variables
Functional balance; mobility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140219016643N9
Registration date:2021-08-04, 1400/05/13
Registration timing:prospective
Last update:2021-08-04, 1400/05/13
Update count:0
Registration date
2021-08-04, 1400/05/13
Registrant information
Name
Behshid Farahmand
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
farahmand.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-09-06, 1400/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of immediate effect of heel lift on mobility and functional balance in elderly with Leg-Length Discrepancy after total knee replacement
Public title
Effect of heel lift on balance in in elderly with Leg-Length Discrepancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least six months have passed since the joint replacement
Knee arthroplasty in one side
Structural shortening of the limb more than 20 mm
Ability to walk without a cane or assistive devices
Exclusion criteria:
History of fracture, orthopedic or neurological injury in the lower limb
professional athlete
Existence of any deformity or disorder in the lower limb other than structural shortening
History of damage to the vestibular system or brain damage, specific visual impairment that affects a person's daily activities
Taking medications that have a significant effect on a person's nervous system and balance
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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
School of Rehabilitation Sciences, Madadkaran Alley., Shahnazari Street., Madar Square, Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
1545913487
Approval date
2021-06-29, 1400/04/08
Ethics committee reference number
IR.IUMS.REC.1400.291
Health conditions studied
1
Description of health condition studied
Knee arthroplasty
ICD-10 code
Z96.65
ICD-10 code description
Presence of artificial knee joint
Primary outcomes
1
Description
Mobility based on Timed up and go test
Timepoint
Before and immediately after the intervention
Method of measurement
Timed up and go test
2
Description
Balance based on berg balance scale
Timepoint
Before and immediately after the intervention
Method of measurement
Berg balance scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use a heel lift based on leg length discrepancy of each person for half an hour.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Zagros orthopedic center
Full name of responsible person
Nabi Ramezani
Street address
Zagros orthopedic center, corner of Adib Alley, South Saadi Ave
City
Ilam
Province
Ilam
Postal code
6931976337
Phone
+98 84 3336 9198
Email
miladzamani.to@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Abbas Motevalian
Street address
5th Floor, Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
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
Behshid Farahmand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and Prosthetics
Street address
School of Rehabilitation Sciences of Iran University of Medical Sciences, Shahnazari St., Mother Square, Mirdamad Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 2059
Email
farahmandb1@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behshid Farahmand
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and Prosthetics
Street address
School of Rehabilitation Sciences of Iran University of Medical Sciences, Shahnazari St., Mother Square, Mirdamad Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
farahmandb1@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Milad Zamani
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Orthotics and Prosthetics
Street address
3rd floor, Baran Complex, Next to Provincial Broadcasting Organization, Keshvari Sq, Beheshti Blvd
City
Ilam
Province
Ilam
Postal code
6931436299
Phone
+98 84 3323 3108
Email
miladzamani.to@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Descriptive information as well as research variables including pre-test and post-test data can be shared.
When the data will become available and for how long
Six months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
To write a systematic review and meta-analysis study.
From where data/document is obtainable
Corresponding author Dr. Behshid Farahmand
Via email to farahmandb1@yahoo.com
What processes are involved for a request to access data/document
The complete information of the applicant should be sent by e-mail along with a letter indicating that the data is used to write a systematic review or meta-analysis.