Protocol summary

Summary
The purpose of this study is to evaluate and compare the effects of eccentric exercise and concentric exercise on postural sway in hemiparetic patients. 36 hemiparetic patients that over 20 years of age, with a history of at least 6 months of suffering from hemiparesis are randomly and not blind divided into two groups. The treatment program included an eight-week (3 time per week) eccentric exercises on a treadmill for one group and an eight-week concentric exercises for the other group in the study. The eccentric exercises are carry out by running on a treadmill at 4° negative slope (downhill). The concentric exercises, however, are conduct by running at 4 degree slope (uphill) on the treadmill. The treatment exercises do with a comfortable treadmill speed for 15 minutes (plus 5 minutes warm-up and 5 minutes cool-down period) for each participant. Displacement and velocity of displacement, Before and after of intervention, in Anteroposterior and Mediolateral directions in both groups of hemiparetic patients are measure and compare.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201504154485N4
Registration date: 2015-11-04, 1394/08/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-04, 1394/08/13
Registrant information
Name
Abdolhamid Hajihasani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1444 1522
Email address
hajihasani@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences vice chancello for research
Expected recruitment start date
2015-08-11, 1394/05/20
Expected recruitment end date
2016-01-10, 1394/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of Eccentric & Concentric Exercises on balance in Patients with Hemiparesis
Public title
Effects of Eccentric & Concentric Exercises On Postural Sway in Patients with Hemiparesis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Subjects with over 20 years of age, with a history of at least 6 months of suffering from hemiparesis, They are all able to run on the treadmill. Exclusion Criteria: Subjects with cognitive impairment, a history of involvement of both hemispheres, cerebellum injuries or other neurological or orthopedic complications affecting the feet
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sealed envelope

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
5 Kilometers of Damghan road
City
Semnan
Postal code
Approval date
2015-06-15, 1394/03/25
Ethics committee reference number
ir.semums.rec.1394.34

Health conditions studied

1

Description of health condition studied
Hemiparasis
ICD-10 code
G-81
ICD-10 code description
Hemiplegia, unspecified

Primary outcomes

1

Description
Postural Sway
Timepoint
Before and after of intervention
Method of measurement
Force plate

2

Description
Displacement of center of pressure
Timepoint
Before and after of intervention
Method of measurement
Force plate

3

Description
Velocity of center of pressure
Timepoint
Before and after of intervention
Method of measurement
Force plate

Secondary outcomes

empty

Intervention groups

1

Description
Eccentric exercises 8 weeks ( 3 time per week and 20 minutes per session) downhill or uphill running protocol on the treadmill
Category
Rehabilitation

2

Description
Concentric exercises 8 weeks ( 3 time per week and 20 minutes per session) downhill or uphill running protocol on the treadmill
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Center Research of Semnan University of Medical Sciences
Full name of responsible person
Street address
5 Kilometers of Damghan road, Semnan
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences Vice chancello for research
Full name of responsible person
Dr Mohamad reza Askari
Street address
5 Kilometers of Damghan road, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences Vice chancello for research
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
Semnan University of Medical Sciences
Full name of responsible person
Abdolhamid Hajihasani
Position
PhD of Physiotherapy, Assistant professor
Other areas of specialty/work
Street address
5 Kilometers of Damghan road, semnan
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
hajihasani41@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abdolhamid Hajihasani
Position
Assistant professor, PhD of Physiotherapy
Other areas of specialty/work
Street address
5 Kilometers of Damghan road, Semnan
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
hajihasani41@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abdolhamid Hajihasani
Position
PhD of Physiotherapy, Assistant professor
Other areas of specialty/work
Street address
5 Kilometers of Damghan road, Semnan
City
Semnan
Postal code
Phone
00
Fax
Email
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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