Protocol summary

Summary
The aim of this study is to examine the effect of passive range of motion exercise in the acute phase of stroke on motor function of the patients. In this randomized controlled trial, patients with stroke who are recruited based on inclusion criteria, are randomly allocated to experimental and control group using closed envelops each of which includes a group name. Inclusion criteria would be ischemic stroke diagnosis, no longer than 6 hours of the stroke onset, score 14-16 based on FOUR criteria, NIHSS 5-42, Age 18-80 years old, Vital signs within normal range; and exclusion criteria would be past history of stroke, fracture or orthopedic disorder in extremities, acute coronary syndrome, heart and respiratory failure, life threatening condition, history of neurologic dysfunction, patients death, intervention sessions less than 6, activity intolerance, patient discharge before intervention termination, and clinical instability within the first 48 hours of intervention. In experimental group, passive range of motion for involved extremities will be implemented within the first 48 hours of strike onset by the researcher. Before intervention, and one month and three months after intervention termination, motor function of the experimental and control group will be measured by Muscle Strength Scale and the measurements will be compared by statistical tests. The person who measures dependent variable would be blind to the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017020213785N4
Registration date: 2017-03-02, 1395/12/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-02, 1395/12/12
Registrant information
Name
Hamid Peyrovi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4404
Email address
h-peyrovi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Tehran University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-09-11, 1393/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of passive range of motion exercises on motor function of patients in acute phase of stroke: a clinical trial.
Public title
Effect of passive range of motion exercises on motor function in stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Ischemic stroke diagnosis, no longer than 6 hours of the stroke onset, score 14-16 based on FOUR criteria, NIHSS 5-42, Age 18-80 years old, Vital signs within normal range Exclusion criteria: Past history of stroke; fracture or orthopedic disorder in extremities; acute coronary syndrome; heart and respiratory failure; life threatening condition; history of neurologic dysfunction
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tehran University of Medical Sciences
Street address
At the corner of Ghods St, Keshavarz Blvd
City
tehran
Postal code
Approval date
2013-07-14, 1392/04/23
Ethics committee reference number
647P

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 intervention, one month an three months after intervention termintion
Method of measurement
Muscle Strength Scale

Secondary outcomes

empty

Intervention groups

1

Description
Experimental group: Passive range of motion exercises for involved extremities will be implemented within the first 48 hours of stroke onset by the researcher according to the protocol, four times daily, each time for 15-40 minutes. In case of patient’s intolerance to the intervention and vital sign instability, the intervention would be stopped. Implementing at least 6 sessions of intervention is necessary. The intensity of the exercise will be moderate at the beginning and will be increased based on the patient’s tolerance.
Category
Rehabilitation

2

Description
Control group: No intervention will be implemented.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Zahrasadat Hoseini
Street address
Poursina Hospital, Poursina Crossroad
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masood Yunesian
Street address
Tehran University of Medical Sciences, at the corner of Ghods St, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Iran University of Medical Sciences
Full name of responsible person
Hamid Peyrovi
Position
Ph.D in Nursing, faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rashid Yasami Ave., Vali-Asr St.
City
Tehran
Postal code
Phone
+98 21 4365 1705
Fax
Email
hamidpeyravi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hamid Peyrovi
Position
Ph.D in Nursing/ Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rashid Yasami Ave, Vali-Asr St.
City
Tehran
Postal code
Phone
+98 21 4365 1705
Fax
Email
hamidpeyravi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hamid Peyrovi
Position
Ph.D in Nursing/ Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rashid Yasami Ave, Vali-Asr St.
City
Tehran
Postal code
Phone
+98 21 4365 1705
Fax
Email
hamidpeyravi@yahoo.con
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...