Protocol summary

Summary
The aim of this study is to identify the effects of the correction exercise program on gait and landing ground reaction force characteristics in individuals with genu valgus. An experimental study with a randomized controlled trial design will be used. Twenty six subjects with genu valgus will be classified in two groups: the experimental group (n=13) and the control group (n=13). The experimental group will conduct correction exercise program for 35-40 minutes at each session, 3 times a week, for 16 weeks, while the control group did not perform any exercise. Two Kistler force plates (Kistler AG, Winterthur, Switzerland) will be used to record the GRF components during bilateral drop landing abd gait with sampling rate of 1000Hz.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016110230657N1
Registration date: 2016-11-18, 1395/08/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-11-18, 1395/08/28
Registrant information
Name
AmirAli Jafarnezhadgero
Name of organization / entity
Mohaghegh Ardabili University
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 0903
Email address
a.jafarnezhad90@basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Mohaghegh Ardabily university
Expected recruitment start date
2016-11-08, 1395/08/18
Expected recruitment end date
2017-03-08, 1395/12/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of specific training on ground reaction forces charactrestics during landing and gait in individuals with genu valgum
Public title
The effect of specific training on ground reaction forces charactrestics during landing in individuals with genu valgum
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age range between 60-70 years; Q angle greater than 18 degree; Medial malleolus distance greater than 6 cm. Exclusion criteria: History of lower limbs injury; History of lower limbs surgery; Body Mass Index greater than 30.
Age
From 60 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ardabil university of medical sciences
Street address
Ardabil province- Ardabil city-Ardabil university of medical sciences
City
Ardabil
Postal code
Approval date
2016-11-03, 1395/08/13
Ethics committee reference number
IR.ARUMAS.REC.1395.77

Health conditions studied

1

Description of health condition studied
Genu valgum
ICD-10 code
Q74.1
ICD-10 code description
Genu valgum

Primary outcomes

1

Description
Ground reaction forces
Timepoint
before and after 16 weeks
Method of measurement
Forceplatform

Secondary outcomes

1

Description
Q angle
Timepoint
before and after 16 weeks
Method of measurement
Goniameter

Intervention groups

1

Description
Intervention group: Elastic tubing (Thera-Band, Akron, Ohio, US) ranging from very low to very high resistance (yellow, red, green, blue, black and silver) will be used. The Intervention group will be performed stretch training protocol (first two weeks) for the hip adductor, biceps femoris and tensor fascia latae muscles consisted of static stretching performed in four sets of 30s for each movement. After stretch training protocols, the experimental group wil be performed resistance thera-band exercises at three times per week for fourteen weeks (i.e., 42 strength training sessions). The participants will be familiarized with the training techniques prior to training. Each exercise session will be consisted of a general warm-up of 10 minutes, followed by a resistance training session (35- 40 minutes) and was completed by a cool-down routine. Exercises were preceded by warm-up sets, while all thera-band training was closely will be supervised and the participants will be received consistent verbal instructions. Following an adaptation phase of four weeks using low external resistance (yellow Thera-Band®, 1 set of 14 repetitions per exercise with a higher resistance only if the subject was obviously unchallenged) exercise intensity was progressively increased by adapting the resistance of the elastic band (based on the Thera-Band® force-elongation table) from yellow to red and further to black. In addition, the exercise volume will be extended by increasing the number of sets from one to two. Rate of progression will be based on individual improvements (band colour will be changed if participant would have been able to perform two more repetitions in the second set) .
Category
Rehabilitation

2

Description
Control group: The control group did not perform any strengthening or stretching exercises and their participants were re-evaluated after 16 weeks.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation centers of Hamadan city
Full name of responsible person
Street address
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
Mohsen Barghamadi
Street address
Department of Physical Education and Sport Sciences, Mohaghegh Ardabili University, Ardabil city, Ardabil province, Iran.
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mohaghegh Ardabili University
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
Mohaghegh Ardabili University
Full name of responsible person
Mohsen Barghamadi
Position
PhD/ Sports Biomechanics
Other areas of specialty/work
Street address
Department of Physical Education and Sport Sciences, Mohaghegh Ardabili University, Ardabil city, Ardabil province, Iran.
City
Ardabil
Postal code
Phone
+98 45 3351 2081
Fax
Email
AmirAlijafarnezhad@gmail.comsalehbarghamadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
AmirAli Jafarnezhadgero
Position
PhD
Other areas of specialty/work
Street address
Department of Physical Education and Sport Sciences, Mohaghegh Ardabili University, Ardabil city, Ardabil province, Iran.
City
Ardabil
Postal code
Phone
+98 45 3351 0903
Fax
Email
AmirAlijafarnezhad@gmail.comA.jafarnezhad90@basu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
AmirAli Jafarnezhadgero
Position
PhD
Other areas of specialty/work
Street address
Department of Physical Education and Sport Sciences, Mohaghegh Ardabili University, Ardabil city, Ardabil province, Iran.
City
Ardabil
Postal code
Phone
+98 45 3351 0903
Fax
Email
Amiralijafarnezhad@gmail.com;A.jafarnezhad90@basu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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