Abstract Purpose: We aimed to compare the effect of mobilizing and immobilizing splints on wrist-fingers motor function after stroke. Methods: In this experimental study, we selected 31 stroke patients and divided them randomly into three groups including: mobilizing splint, immobilizing splint and control group. Selected patients have spasticity in their hand based on modified Ashworth scale > 1. Also they have not severe cognitive impairments. Participants in intervention groups wore their own splints for eight weeks, five days per week and on average six hours per day. Motor function was measured by Fugl- Meyer (FM) scale at baseline and eighth week. The one-way ANOVA was used to compare scores of FM scale between three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009294836N1
Registration date:2010-11-28, 1389/09/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-28, 1389/09/07
Registrant information
Name
Mohammad Heidari
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 676 6201
Email address
hr-heidari@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2009-05-31, 1388/03/10
Expected recruitment end date
2009-10-02, 1388/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of mobilizing and immobilizing splints on hand motor function in stroke patients
Public title
Effect of splints on hand function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hemiplegia in post-stroke patients have occurred more than 12 months before the beginning of the study, having no Botax injection, spasticity score based on modified Ashworth scale>1, no functional movement in involved hand, age between 45 to 75.
Exclusion criteria: Presence of non-stroke related problems in involved upper limb, presence of severe cognitive problems.
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
31
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
Ethics Committee of Army University of Medical Sciences
Street address
Etemadzadeh Avenue, Fatemi St., Tehran, Iran.
City
Tehran
Postal code
Approval date
2009-05-02, 1388/02/12
Ethics committee reference number
1021
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
motor function
Timepoint
Before the beginning of the study and 8 week after that.
Method of measurement
Fugl-Meyer scale, quantitative
Secondary outcomes
1
Description
spasticity
Timepoint
onset of study, 8th week
Method of measurement
modified Ashworth scale
Intervention groups
1
Description
Participants in mobilizing splint group wore a mobilizing splint for eight weeks, five days per week and on average six hours per day. Mobilizing splint placed on the forearm and hand and allowed patients to move their covered parts by splint just only in Metacarpophalangeal joints. They also received traditional rehabilitation including Bobath exercises.
Category
Rehabilitation
2
Description
Participants in immobilizing splint group wore an immobilizing splint for eight weeks, five days per week and on average six hours per day. Immobilizing splint placed on the forearm and hand and did not permit patients to move any of their covered parts by splint. They also received traditional rehabilitation including Bobath exercises.
Category
Rehabilitation
3
Description
Participants in control group only received traditional rehabilitation including Bobath exercises.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Mohammad Heidari
Street address
Daneshju St., Velenjak, Evin, Tehran, Iran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Army University of Medical Sciences
Full name of responsible person
Mrs. Doctor Fereshteh Dormanesh
Street address
Etemadzadeh Avenue, Fatemi St., Tehran, Iran.
City
Tehran
Grant name
پاين نامه فرهيختگان
Grant code / Reference number
88010
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Army 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
Army University of Medical Sciences
Full name of responsible person
Mohammad Heidari
Position
Master of science/Instructor
Other areas of specialty/work
Street address
Rehabilitation Center of Behkoosh, Janbazan Boulevard, Gorgan, Iran.