The purpose of this study was to investigate the effect of biofeedback on the Quality of life and self-efficacy of stroke patients
Design
In this study, 60 stroke patients with a Inclusion criteria
are referred to the physiotherapy department are selected. The participants are randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
This study included all patients with stroke who attended the physiotherapy center of Imam Raza Hospital in Mashhad, Iran. The participants were randomly divided into two groups based on block randomization (case and control) after screening based on the inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the patients with stroke for first time according to computed tomography (CT) scan and magnetic resonance imaging (MRI)؛ the length of disease more than 3 months and lower than 3 years؛ age of stroke patients was 18-65 years؛ ability to walking for 10 meters with or without assist devices؛ hemiplegia and without any cognitivedisorders
Exclusion criteria:Unwilling to Participate in the Study؛ Absent for 3 Sessions in Biofeedback Exercise
Intervention groups
In the Intervention Group, Biofeedback (20-min sessions, twice weekly, for 8 weeks) was performed
Main outcome variables
Improving Quality of Life and Self-Efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171023036970N1
Registration date:2018-01-21, 1396/11/01
Registration timing:retrospective
Last update:2018-01-21, 1396/11/01
Update count:0
Registration date
2018-01-21, 1396/11/01
Registrant information
Name
zohre najafi
Name of organization / entity
shahid beheshti university of medical sience
Country
Iran (Islamic Republic of)
Phone
+98 915 381 9224
Email address
zohrenajafi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2006-03-20, 1384/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Biofeedback on the Quality of life and self-efficacy
in Rehabilitation of Stroke Patients
Public title
The Effect of Biofeedback on Stroke Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The Patients With Stroke For The First Time
Age of Stroke Patients Was 18-65 Years
Hemiplegia
Without Any Cognitive Disorders
Exclusion criteria:
Unwilling to Participate in the Study
Absent for 3 Sessions in Biofeedback Exercise
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were randomly divided into two groups based on block randomization (case and control) after screening based on the inclusion and exclusion criteria.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and their caregivers (family) were unaware of intervention.
The completion of questionnaires in the control and intervention group was done by researcher and researcher's assistance separately.
Placebo
Not used
Assignment
Parallel
Other design features
randomized clinical trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical sciences
Street address
Mashhad- daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.MUMS.REC.1395.191
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Quality of Life
Timepoint
8 Weeks
Method of measurement
Quality of Life Questionnaire
Secondary outcomes
1
Description
Self-Efficacy
Timepoint
8 weeks
Method of measurement
Questionnaire
2
Description
Quality of Life
Timepoint
8 weeks
Method of measurement
Questionnaire
Intervention groups
1
Description
In the intervention group, biofeedback exercises are performed twice a week for 8 weeks each session for 20 minutes at the physiotherapy center of Imam Reza Hospital.
Category
Rehabilitation
2
Description
In the control group, conventional physical therapy is performed twice a week for 8 weeks each session for 20 minutes in the physiotherapy center of Imam Reza Hospital.