Comparative study of the effect of lower limb constraint induced movement therapy with conventional physical therapy on gait kinematics and functional tests in hemiparetic patients
Design
Randomized comparative study, with experimental and control groups, parallel, single blinded, randomized via block randomization with 15 participants in each group
Settings and conduct
This study was conducted in Qaem hospital in Mashhad. Patients with stroke in experimental group received constraint induced movement therapy via a shoe lift with 6mm thickness in conjunction with conventional physiotherapy. Patients in control group received only conventional physiotherapy. The outcome measures of the study included gait kinematics and functional tests which were recorded before and after intervention in each group and then were compared between the two groups. Persons who were involved in collecting and analyzing of data were blinded to group allocation.
Participants/Inclusion and exclusion criteria
1) Age range of 40-70 years
2) First ever stroke
3) Unilateral hemiparesis
4) Chronic stroke
5) Modified Ashworth Scale < or = 2
6) ability to walk without assistive device
7) weight bearing asymmetry
Intervention groups
Experimental group: constraint induced movement therapy in conjunction with conventional physiotherapy
Control group: conventional physiotherapy
Main outcome variables
Weight bearing asymmetry- COP velocity changes- Spatial temporal gait measures- The changes of angular velocity of the lower limb joints during gait- Berg Balance Scale- Timed up and go
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190603043808N1
Registration date:2019-07-24, 1398/05/02
Registration timing:retrospective
Last update:2019-07-24, 1398/05/02
Update count:0
Registration date
2019-07-24, 1398/05/02
Registrant information
Name
Hossein Asghar Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6710
Email address
hosseiniha@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2011-08-19, 1390/05/28
Expected recruitment end date
2012-08-18, 1391/05/28
Actual recruitment start date
2011-08-19, 1390/05/28
Actual recruitment end date
2012-08-18, 1391/05/28
Trial completion date
2012-11-18, 1391/08/28
Scientific title
Effect of " constraint induced movement therapy " of lower limb on gait kinematics and functional test of lower limbs in hemiparetic patients
Public title
Effect of constraint induced movement therapy in hemiparetic patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 40-70
First ever stroke
Chronic unilateral hemiparesis
Modified Ashworth Scale < or = 2
Ability to walk without asisstive device
Weight bearing asymmetry
Exclusion criteria:
Bilateral hemiparesis
Occiput and limbic system lesions
Cognitive impairments
Aphasia
Any neurologic condition in addition to stroke
Any orthopedic condition that could affect walking pattern
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Personnel who collect and analyse the outcome measures were blinded to study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice-Chancellor for research, Ghorashi Building, University street
"Experimental group": Patients in Experimental group received lower limbs constraint induce movement therapy (via a 6 mm shoe lift under the non-paretic leg) in conjunction with conventional physiotherapy for 6 weeks."
Category
Rehabilitation
2
Description
"Control group:Patients in Control group only received conventional physiotherapy for 6 weeks."