The efficacy of modify constraint-induced movement therapy and functional electrical stimulation on upper extremity function in patients with stroke in sub acute stage of recovery
Effect of constraint-induced motion therapy modification and functional electrical stimulation on the upper limb function of patients with stroke in the subacute stage of recovery
Design
Clinical trial,Two parallel groups randomised trial, blind, sample size 56
Settings and conduct
Initially, the severity of the stroke will be determined by NIHSS criteria. Then, the patients will be evaluated by WMFT and assign into two groups using Permuted block randomization methods. In one group FES plus exercise, and for the other group FES plus exercise and CIMT will be performed. After the end of treatment, both groups of patients will be assessed again by WMFT, with respect to performance and duration of motor tasks. Also, after one month, the outcomes are re-evaluated. At the interval between the end of the treatment and 1 month follow-up, FES plus exercise will continue for both groups.
Participants/Inclusion and exclusion criteria
Patients with lacunar stroke have entry conditions and patients with brain hemorrhage are not included in the study.
Intervention groups
All patients receive FES after being admitted to one of the treatment groups. Electric stimulation will be used for ten sessions each day and a total of 10 days for patients. All patients will have at least 10 days exercise in the field of lice and shoulder elbow and shoulder in the clinic as well as once at home. All patients in the target group will use one of the commonly used CIMT methods. The patient will use this glove for a healthy upper limb for 10 days and 6 hours a day.
Main outcome variables
The overall performance score of the tests is based on the Wolf test
The time of the tests is based on the Wolf test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516034003N4
Registration date:2018-04-24, 1397/02/04
Registration timing:prospective
Last update:2018-04-24, 1397/02/04
Update count:0
Registration date
2018-04-24, 1397/02/04
Registrant information
Name
Kamran Ezzati
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3369 0099
Email address
kamranezzati@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of modify constraint-induced movement therapy and functional electrical stimulation on upper extremity function in patients with stroke in sub acute stage of recovery
Public title
The effects of modified constraint-induced movement therapy and functional electrical stimulation in stroke patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The history of lacunar brain stroke, which is diagnosed on the basis of CT scans and lasts from one week to three months
Middle-aged men and women (over 45 years of age) with diagnosis of stroke
The mother tongue is Persian and is able to understand oral instructions
It is able to open the wrists and fingers and two other fingers at 10 degrees
Patients who are able to maintain balance in sitting conditions. That means they can sit up to 30 seconds without help and support
The severity of the disease will be, according to the National Institutes of Health Stroke Scale(NIHSS)scale, an average NIHSS = 8-16
Exclusion criteria:
Patients with a history of arm or hand disability
Patients with shoulder and shoulder pain
Patients with cognitive impairment or, in other words, Mini–Mental State Examination(MMSE) scores below 24
Patients with a history of other neurological diseases including Parkinson's disease, multiple sclerosis and traumatic brain injury in their medical records.
Patients with cerebral hemorrhage
Age
From 45 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
The grouping method will be Permuted block randomization . So, blocks of 10 people including 5 participants in the intervention group and 5 participants in the control group are allocated.
Blinding (investigator's opinion)
Single blinded
Blinding description
The examiner won't know anything about the kind of treatment. Therapists will also not know anything about grouping and kind of interventions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Guilan University of Medical Sciences
Street address
5th floor, Central office of Guilan University of Medical Sciences, Namjoo St., Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2017-01-03, 1395/10/14
Ethics committee reference number
IR.GUMS.REC.1396.463
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
The overall performance score of the tests is based on the Wolf test. According to Wolf's ability to perform an arm, the scores are between zero and five, with a score of 0 means the absence of the affected limb and a score of five, meaning a move close to the normal. Finally, the median time and total scores will be recorded as a total score.
Timepoint
Before the intervention, 10 and 30 days after the intervention
Method of measurement
Wolf's Questionnaire
2
Description
The time of the tests will be recorded based on the Wolf test according to the Wolf Mean Time Scale and the total performance scores as the total score.
Timepoint
Before the intervention, 10 and 30 days after the intervention
Method of measurement
Wolf's Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For this group of patients, functional electrical stimulation (FES) and exercise with modified constraint induced movement therapy will performed
Category
Rehabilitation
2
Description
Control group: For this group of patients, FES and exercise will performed