Objectives: The effect of task oriented training and conventional physical therapy on balance in hemiplegic patients fallowing stroke will be compared.
Design: In this clinical trial, 20 hemiplegic patients fallowing stroke will be divided randomly (people with odd inclusion number in the control group and those with even inclusion number in experimental group) in two groups of task oriented training and conventional physical therapy.
Setting and conduct: Individuals will participate in 4-weeks therapy sessions 3 times a week for about 2 hours.
Major inclusion and exclusion criteria: Inclusion criteria include: hemiplegia secondary to stroke; clear asymmetry in weight bearing; the ability to independent walking for at least 10 meters; passing less than three months after stroke and the Berg Balance Scale in the range of 30 to 40 and Exclusion criteria include: impaired vision; the absence of any neurological or orthopedic diseases affecting patients postural disorder and any disease that limited patient's participation in the study.
Interventions: Task-oriented training and conventional physiotherapy exercises
Main outcome variables include: The Berg Balance Scale will be used to measure functional balance and pressure distribution of foot, the center of pressure path length and the center of pressure confidence ellipse area will be used to evaluate static balance by means of pressure distribution zebris system while standing with open eyes before and after the treatment.
General information
Acronym
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IRCT registration information
IRCT registration number:IRCT2015100224297N1
Registration date:2015-10-12, 1394/07/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-10-12, 1394/07/20
Registrant information
Name
Soodeh Arabzadeh
Name of organization / entity
Tabriz Univercity of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 31 3336 1993
Email address
soltania@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-10-21, 1394/07/29
Expected recruitment end date
2015-12-16, 1394/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of task oriented training and conventional physiotherapy on balance in hemiplegic patients following stroke
Public title
Compare the effect of task oriented training and conventional physiotherapy on balance in stroke pateints
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include: hemiplegia secondary to stroke; clear asymmetry in weight bearing; the ability to independent walking for at least 10 meters; passing less than three months after stroke and the Berg Balance Scale in the range of 30 to 40 and Exclusion criteria include: impaired vision; the absence of any neurological or orthopedic diseases affecting patients postural disorder and any disease that limited patient's participation in the study.
Age
From 45 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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
1
Registry name
---
Secondary trial Id
---
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Assistance Research and Technology, Third floor, Central Building (2), Tabriz University of Medical Sciences, Golgasht St, Tabriz
City
Tabriz
Postal code
51665118
Approval date
2014-03-03, 1392/12/12
Ethics committee reference number
92223
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G96.8
ICD-10 code description
Other disorders of central nervous system
Primary outcomes
1
Description
Functional balance
Timepoint
Before and after treatment
Method of measurement
Berg Balance Scale
2
Description
Sway
Timepoint
Before and after treatment
Method of measurement
The center of pressure path length and the center of pressure confidence ellipse area
3
Description
Symmetry
Timepoint
Before and after treatment
Method of measurement
The plantar pressure distribution of foot
Secondary outcomes
1
Description
---
Timepoint
---
Method of measurement
---
Intervention groups
1
Description
Intervention group: Task oriented training,three times a week for four weeks over twelve sessions. Each session takes about 2 hours.
1) sitting on a chair and reaching objects in all directions at a distance of more than arm's length; 2) forward, backward and side way stepping up; 3) flexion and extension the affected knee, while the affected foot located on the exercise step; 4) stepping over obstacles with different heights; 5) standing up from a chair, walking four steps forward, touching a stool and then returning to the chair; 6) sitting on a Swiss ball while doing range of motion and balance exercise in the trunk and upper extremities; 7) double leg stand for 10 seconds; 8) tandem stand (the heel of one foot in front of the other foot) for 10 seconds; 9) standing up from a chair without using the arms; 10) tandem walking forward and backward7, 16. The four last exercises have been done in different situation as follows: 1) with open eyes and a hard surface, 2) with open eyes and a soft surface, 3) with closed eyes and hard surface; 4) with closed eyes and smooth surface
Category
Rehabilitation
2
Description
Control group: conventional physiotherapy, three times a week for four weeks over twelve sessions. Each session takes about 2 hours.
Exercises to improve balance, increase muscle strength, range of motion and walking through weight training or weight transfer in the parallel bars, mats exercise (strengthening, stretching, range of motion) and correct gait training in parallel bar
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
physiotherapy cilinic of Asadabady hospital
Full name of responsible person
Abbas Soltani Somee, PhD of Physiotherapy, Assistant professor
Street address
Asadabadi Hospital, Adjacent Agricultural high schools, Spring Street before the intersection Azerbaijan , Tabriz
City
Tabriz
2
Recruitment center
Name of recruitment center
physiotherapy clinic of Razi
Full name of responsible person
Sakineh Goljaryan, PhD of Physiotherapy, Assistant professor
Street address
Elgoli road, Razi hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Center of Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
Vice chancellor for research and technology, Third floor, Central Organization2, Tabriz University of Medical Sciences, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Center of Tabriz University of Medical Sciences
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
Faculty of Rehabilitation, Tabriz University of Medical Sciences
Full name of responsible person
Abbas Soltani Somee
Position
PhD of Physiotherapy, Assistant professor
Other areas of specialty/work
Street address
Physiotherapy Department, Faculty of Rehabilitation, Vali Asr Blvd, Tavanir St, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3331 1293
Fax
+98 41 3333 4647
Email
soltania@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Rehabilitation, Tabriz University of Medical Sciences
Full name of responsible person
Abbas Soltani Somee
Position
PhD of Physiotherapy, Assistant professor
Other areas of specialty/work
Street address
Physiotherapy Department, Faculty of Rehabilitation, Vali Asr Blvd, Tavanir St, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3331 1293
Fax
+98 41 3333 4647
Email
soltania@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Rehabilitation, Tabriz University of Medical Sciences, Tabriz
Full name of responsible person
Soodeh Arabzadeh
Position
M.Sc student of Physiotherapy
Other areas of specialty/work
Street address
Physiotherapy Department, Faculty of Rehabilitation, Vali Asr Blvd, Tavanir St, Tabriz
City
Tabriz
Postal code
Phone
+98 31 3336 1993
Fax
+98 31 3336 7292
Email
soodeharabzadeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)