Introduction and background: Following stroke, Patients suffer from hand disability. Objectives: This study was conducted to determine effects of adjustable wrist hand Splint on Spasticity and Range of Motion in Post stroke Patients.
Design: This study was done by a Clinical trial
Setting and conduct: With 15 patients with stroke (aged 40-65) in Occupational clinics of Rofeydeh Rehabilitation Hospital and Faculty of Rehabilitation of Iran University of Medical Sciences. All patients were categorized in two groups of control (8 patients) and experimental (7 patients). Occupational exercises were done for both groups for four weeks and
Intervention: Adjustable Wrist hand Splint were used in only experimental group.
Eligibility criteria:
Men and Women suffered stroke between 6-12 month, and have wrist Spasticity ≥1 According to Modified Ashworth scale. Variables: For wrist spasticity and Range of Motion were measured by Modified Ashworth Scale and Goniometry, respectively, before and 4 weeks after of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903193754N2
Registration date:2010-06-09, 1389/03/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-09, 1389/03/19
Registrant information
Name
Mohammah Ali Javanshir
Name of organization / entity
Iran University of Medical sciences ( IUMS )-Rehabilitation School
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7159
Email address
majavan@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical sciences ( IUMS )
Expected recruitment start date
2009-03-13, 1387/12/23
Expected recruitment end date
2009-11-06, 1388/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Adjustable Wrist hand Splint on Spasticity and Active Range of Motion on Post stroke patients
Public title
Effect of Hand Splint on Stroke Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Age of 40 to 65, 2- Patients within 6-12 month from onset stroke, 3- wrist and finger spasticity more than 1 degree according to modified Ashworth scale 4- no active wrist extension.
Exclusion criteria were:1- History of former stroke 2-Any neurologic disease (such as, Parkinson or Myopathy) Which could intervene the treatment procedure.
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Do rehabilitation exercises for both groups. Give splint to experimental group
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rehabilitation School.Iran University of Medical sciences ( IUMS )
Street address
Shahnazari Street, Mirdamad blvd.Rehabilitation School
City
Tehran
Postal code
439115875
Approval date
2009-02-02, 1387/11/14
Ethics committee reference number
81
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
G81.1
ICD-10 code description
Spastic hemiplegia
Primary outcomes
1
Description
Spasticity
Timepoint
Before study and After 4 weeks
Method of measurement
Modofied Ashworth Scale
2
Description
Range of Motion
Timepoint
Before study and After 4 Weeks
Method of measurement
Manual Goniometer
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
In control group,Patients received Rehabilitation therapy for 4 weeks
Category
N/A
2
Description
use the Adjustable Wrist hand Splint for Experimental group for 4 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Occupational Therapy Of Rehabilitation School Iran University of Medical sciences ( IUMS )
Full name of responsible person
Malahat Akbarfahimi
Street address
Shahnazari Street, Mirdamad blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Iran University of Medical University
Full name of responsible person
Maziar Moradi lake
Street address
Hemat Express Way -near milad hospital-Iran University of Medical University-centeral block-
City
Tehran
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, Iran University of Medical 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
Iran University of Medical sciences ( IUMS )
Full name of responsible person
Mohammad Ali Jvanshir.Eng
Position
Master of Sience - Academic member
Other areas of specialty/work
Street address
Shahnazari Street, Mirdamad blvd.Tehran, Iran-Rehabilitation School
City
Tehran
Postal code
158754391
Phone
+98 21 2222 7159
Fax
Email
Majavan@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rehabilitation School
Full name of responsible person
Elahe Tutunchi
Position
Master of Sience
Other areas of specialty/work
Street address
Shahnazari Street, Mirdamad blvd-Tehran
City
Tehran
Postal code
15875-4391
Phone
+98 22227159
Fax
Email
Tutunchy_To@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)