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The effect of six weeks of the functional training on gait kinematics of Down syndrome

Protocol summary

Summary
The purpose of this study was to evaluation the effect of functional training on gait kinematics of adult with Down syndrome. 13 men with Down syndrome who were aged 18 years or more and also their disease is caused by trisomy 21 participated in this study from Down Syndrome Association of Iran. The kinematics variable, The isokinetic peak torque of lower extremities and static balance were assessed by motion analysis, Isokinetic Dynamometer, and Stork Balance Stand Test respectively before and after application of the training program. Because knee extensor strength is the most influential variable in predicting timed task performance (chair rise, gait speed, and stair ascent and descent), all subjects randomly allocated to exercise (n=7) and control (n=6) groups based on knee extensor’s isokinetic strength results. The experimental group received functional training which consisted of walking on treadmill and step-up and down performed thrice a week for 6 weeks. There were 4 fitness bands colours (violet, red, yellow, and blue) of increasing resistance for treadmill training and 4 medicine balls (2, 3 and 4 kg) for step-up and down. The control group continued with their usual activities. Research outcome were improvement in step length, step width variability, step length variability, walking speed, ankle range of motion, knee range of motion, isokinetic peak torque of lower extremities, and static balance

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013102815202N1
Registration date: 2014-06-07, 1393/03/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-06-07, 1393/03/17
Registrant information
Name
Fatemeh Peyk
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 1766
Email address
f.peik@mail.sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University
Expected recruitment start date
2013-04-30, 1392/02/10
Expected recruitment end date
2013-05-05, 1392/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of six weeks of the functional training on gait kinematics of Down syndrome
Public title
The effect of functional traininig on walking
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: they were aged 18 years or more; their disease is caused by trisomy 21; able to follow simple instructions; physical health; and their guardians will agreement to participate in the study. Exclusion criteria: cardiovascular conditions; blindness; and deafness
Age
From 21 years old to 38 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 13
Randomization (investigator's opinion)
Randomized
Randomization description
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
Motor Behavior Group of Shahid Beheshti University
Street address
Shahid Beheshti University, Velenjak, Tehran
City
Tehran
Postal code
1983963113
Approval date
2013-02-11, 1391/11/23
Ethics committee reference number
15667

Health conditions studied

1

Description of health condition studied
down syndrome
ICD-10 code
Q90
ICD-10 code description
Down syndrome

Primary outcomes

1

Description
kinematics of walking
Timepoint
Before intervention and 6 weeks after endig intrvention
Method of measurement
Motion Analysis System

Secondary outcomes

1

Description
The isokinetic peak torque
Timepoint
before intervention six weeks after intervention
Method of measurement
by isokinetic dynamometer

2

Description
static balance
Timepoint
before intervention six weeks after intervention
Method of measurement
by Standing Stork Test

3

Description
muscle activitu
Timepoint
before intervention six weeks after intervention
Method of measurement
by electromyography

Intervention groups

1

Description
The experimental group: Three to five minutes of active stretching exercise undertaken prior to each session. Trainings continued with walking on treadmill and step-up and down. The treadmill training protocol included tow 10-minut periods (with 0% incline). There were 4 fitness bands colours (violet, red, yellow, and blue) of increasing resistance which was installed participant’s shoes. The step-up and down training was carried out with medicine balls which were 2, 3, 4 kilogram. Participants should do plantar flexion when place on the ground. In order to enhancing motivation of participant, we installed a hoop proportionate with their height in front of them and were asked to drop medicine ball into the hoop with plantar flexion. The protocol included 2 sets until they reached fatigue with 2- kilogram-weight medicine ball. The rest period was twice as long as training.
Category
Other

2

Description
The control group: continued with their usual activities
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Down Syndrome Association
Full name of responsible person
Porandokht Bonyadi
Street address
Number 2 1, Shahid Abolfazl Haj Rezaee, Tohid, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Dr Nassour Ahmadi
Street address
Shahid Beheshti University, Velenjak, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Fariborz Hovanloo
Street address
Shahid Beheshti University, Velenjak,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University
Proportion provided by this source
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
Shahid Beheshti University
Full name of responsible person
Fariborz Hovanloo
Position
doctorate/ Professor of Shahid Beheshti University
Other areas of specialty/work
Street address
Shahid Beheshti University, Velenjak,Tehran
City
Tehran
Postal code
1983963113
Phone
+98 21 29901
Fax
Email
fhovanloo@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
shahid beheshti university
Full name of responsible person
Fatemeh Peyk
Position
post gratuate
Other areas of specialty/work
Street address
Shahid Beheshti University, Darake,Evin,Tehran
City
Tehran
Postal code
1983963113
Phone
+98 21 29901
Fax
Email
fatemehpeyk@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Fatemeh Pyk
Position
post graduate/ student
Other areas of specialty/work
Street address
Shahid Beheshti University, velenjak, Tehran
City
Tehran
Postal code
1983963113
Phone
+98 21 29901
Fax
Email
fatemehpeyk@yahoo.com
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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