The effect of home based rehabilitation continuous care program based on BASNEF model on functional capacity and increasing range of motion and flow mediated dilatation in stroke survivors
Investigating the effect of home based rehabilitation intervention on functional Capacity in stroke survivors
Design
This study is a randomized controlled clinical trial with parallel group design
Settings and conduct
This study was performed in al-Zahra hospital in Isfahan.The predicted sample at the beginning of the study was 70, which fell to 40 for the lack of eligible patients. 40 stroke patients were randomly assigned to intervention and comparison groups based on random numbers table. Then, the intervention group participated in a two-part
face to face training session. At the time of discharge from the hospital, a CD regarding home base rehabilitation exercises were delivered to the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients who suffered from first stroke without wernicke's aphasia with stroke severity 7 <NIH <20
Exclusion criteria:Patients with subarachnoid hemorrhage and cardiac abnormality
Intervention groups
Intervention group: Two intervention sessions were provided to the patients in the intervention group at the time of hospitalization based on the constructs of the BASNEF model. Then they were given a CD related to rehabilitation exercises at home when they were discharged from the hospital.
Control group: Received usual rehabilitation interventions in the hospital and rehabilitation centers.
Main outcome variables
Functional capacity; Range of motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180827040885N1
Registration date:2018-12-12, 1397/09/21
Registration timing:retrospective
Last update:2018-12-12, 1397/09/21
Update count:0
Registration date
2018-12-12, 1397/09/21
Registrant information
Name
Fatemeh Esteki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3243
Email address
fatemehesteki@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-05-12, 1394/02/22
Expected recruitment end date
2016-12-23, 1395/10/03
Actual recruitment start date
2015-05-12, 1394/02/22
Actual recruitment end date
2018-02-14, 1396/11/25
Trial completion date
2018-06-01, 1397/03/11
Scientific title
The effect of home based rehabilitation continuous care program based on BASNEF model on functional capacity and increasing range of motion and flow mediated dilatation in stroke survivors
Public title
The effect of home based rehabilitation program on functional capacity in stroke survivors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
First 24 to 72 hours after stroke
First stroke patients
Stroke severity based on 7<NIH <20
Disability and disorders due to stroke in the upper and lower limbs from 25 to 90 according to the fugl-Meyer test
Without wernicke's aphasia
Exclusion criteria:
Patients with Subarachnoid Hemorrhage and Uncontrollable Blood Pressure
Cardiac Abnormality, Sever Heart Arrhythmia and Hyper tonic cardiomyopathy
Oxygen Dependency
Severe renal and hepatic failure
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the number of primary samples was estimated to be 70, but due to the low number of eligible patients, this number was reduced to 40.40 patients who were admitted to Isfahan Alzahra Hospital due to stroke were selected by convenience sampling and assigned to intervention and control groups using systematic sampling and random number table.
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 Isfahan University of Medical Sciences
Street address
Hezarjerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2016-11-05, 1395/08/15
Ethics committee reference number
IR.MUI.1395.3.046
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G46.3
ICD-10 code description
Brain stem stroke syndrome
Primary outcomes
1
Description
Functional Capacity
Timepoint
Before and 3 months after the intervention
Method of measurement
Fugl-Meyer
2
Description
Range of motion
Timepoint
Before and 3 months after the intervention
Method of measurement
Fugl-Meyer
3
Description
Flow mediated dilatation
Timepoint
Before and 3 months after the intervention
Method of measurement
Ultra sound imaging
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Initially, for the patients with a stroke who had the criteria for entering the study, during the hospital stay, two training sessions( each session 30 minutes) based on the structures of the BASNEF model were presented face to face. During these sessions, initial training was provided on the importance of rehabilitation exercises to patients and their family members.Then, at the time of discharge from the hospital, each patient received an instructional CD-ROM on how to do home-based rehabilitation exercises. The follow up was done weekly for 3 months by the researcher for each patient.
Category
Rehabilitation
2
Description
Control group: The control group received routine rehabilitation care at the hospital and after discharge.