The main aim of this study was to investigate the effect of functional stretching exercises on functional outcomes in stroke patients.
Materials and Methods: This study was a single-blinded (examiner) randomized control trial. Fifteen stroke patients as experimental group and fifteen stroke patients as control group wiht spasticity (Modified Modified Ashworth Scale>1) and without deformity in ankle joint with simple randomization participated in this study. Subjects in experimental group participated in a functional stretching training program at the rehabilitation center three times a week for 4 weeks. Subjects in both groups were evaluated before the training, at the end of training, and 2month follow-up. Clinical assessments such as measurement of spasticity measured with use of Modified Modified Ashworth Scale (MMAS). Functional outcomes evaluated with use of timed up-and-go test (TUG) and 10-meter walking timed test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610194738N6
Registration date:2016-12-21, 1395/10/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-21, 1395/10/01
Registrant information
Name
Khosro Khademi Kalantari
Name of organization / entity
Shahid Beheshti university of medical sciences, Faculty of Rehabilitation
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1411
Email address
k_khademi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-05-31, 1394/03/10
Expected recruitment end date
2016-05-30, 1395/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Functional Stretching Exercises on Functional Outcomes in Spastic Stroke Patients: A Randomized, Controlled Trial
Public title
The Effect of Muscular Stretching on Functional Outcomes After Stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Unilateral brain stroke; Spasticity in ankle based on the persian version of modified modified Ashworth scale (MMAS.>1); Ability to walk with or without assistive devices ; Adequate mental status with score above 24 according to persian version of Minimental Status Scale ; Adequate general health ; enough range of motion in ankle joint. Exclusion criteria: Contracture and deformity in ankle joint; Pain in lower limb; participation in sport activities or physical therapy ; Using anti-spastic medication; Other neurological diseases such as parkinson.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study we used simple randomization with use of random-number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Building number 2, Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital , Velenjack
City
Tehran
Postal code
Approval date
2015-12-27, 1394/10/06
Ethics committee reference number
IR.SBMU.REC.1394.133
Health conditions studied
1
Description of health condition studied
Brain stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
timed up-and-go test (TUG)
Timepoint
baseline, after and two month after intervention
Method of measurement
With use of cornomometer
2
Description
10-meter walking timed test
Timepoint
baseline, after and two month after intervention
Method of measurement
With use of cornomometer
Secondary outcomes
1
Description
spasticity score
Timepoint
baseline, after and two month after intervention
Method of measurement
MMAS
2
Description
subjective experience
Timepoint
baseline, after and two month after intervention
Method of measurement
VAS
Intervention groups
1
Description
Functional stretching of gastrocnemius muscle will be applied to intervention group.
Category
Rehabilitation
2
Description
No stretch will be applied to control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy clinic, School of Rehabilitation, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khosro Khademi Kalantari
Street address
School of Rehabilitation, Opposite to Bou Ali Hospital, Damavand Road, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chacellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Building number 2, Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital , Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chacellor for research of Shahid Beheshti 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
School of Rehabilitation, Shahid Beheshti School of Rehabilitation, Shahid Beheshti University of Me
Full name of responsible person
Khosro Khademi Kalantari
Position
Professor
Other areas of specialty/work
Street address
School of Rehabilitation, Opposite to Bou Ali Hospital, Damavand Road
City
Tehran
Postal code
Phone
+98 217756140700
Fax
Email
khosro_khademi@yahoo.co.ukk_khademi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
school of rehabilitation, Shahid Behshti University of Medical sciences
Full name of responsible person
khosro klhademi kalantari
Position
professor
Other areas of specialty/work
Street address
Opposit to Bou Ali Hospital, Dmavand Road
City
Tehran
Postal code
Phone
+98 217756140700
Fax
Email
khosro_khademi@yahoo.co.ukk_khademi@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti university of medical sciences, Faculty of Rehabilitation
Full name of responsible person
Khosro Khademi Kalantari
Position
professor
Other areas of specialty/work
Street address
Opposit to Bou Ali Hospital, Damavand Road
City
Tehran
Postal code
Phone
+98 217756140700
Fax
+98 21 7756 1406
Email
k_khademi@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)