Protocol summary

Study aim
The study of the simultaneous effect of therapeutic motion and heat therapy using Vanda apparatus on the extent of motion and muscle stiffness of patients in the intensive care unit
Design
Two arms parallel group randomized trial, supportive purpose with 38 patients
Settings and conduct
In this research, which is an interventional study, 38 patients who were admitted to the ICU of Shahid Beheshti Hospital of Kashan and who were discharged after reaching a steady state status were selected. Then, if the conditions for entering the study are met, the method of doing work will be explained to relatives of the patient. If the fellows are willing to conduct a study on their patients at home, written consent will be provided upon admission to the study and prior to randomization. Then, the patients were divided into two groups of 19 control and Simple randomization were done. These patients will be examined for 21 days. Before any intervention, the environmental conditions in terms of light, temperature, and sound are identical in both groups. It should be noted that the researcher will not perform any additional interventions other than the function of the device in the test group, and also a prohibition on what is done by the attendants at home, except for lack of massage in the lower limb of the test group, and in the control group no action is taken and only Variables are measured at specific times. To carry out heat therapy, the device twice a day for twenty minutes to slowly warm the patient's lower extremity to achieve its therapeutic effect.
Participants/Inclusion and exclusion criteria
1 - Patients who have been admitted to ICU and need Home Care due to a general condition. 2 - Patient Family Satisfaction. 3 - Good general condition for the patient.
Intervention groups
Controlling: Absence of simultaneous motion and heat therapy using the Vanda machine Intervention: Recipient of simultaneous motion and thermal therapy using the Vanda machine
Main outcome variables
Motion Therapy, Heat Therapy, Motion and muscle stiffness, Patients in intensive care units

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180213038713N1
Registration date: 2018-05-14, 1397/02/24
Registration timing: retrospective

Last update: 2018-05-14, 1397/02/24
Update count: 0
Registration date
2018-05-14, 1397/02/24
Registrant information
Name
Habibolah Dashti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2290
Email address
habibdasht@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-24, 1395/02/05
Expected recruitment end date
2017-04-25, 1396/02/05
Actual recruitment start date
2016-04-24, 1395/02/05
Actual recruitment end date
2017-04-25, 1396/02/05
Trial completion date
empty
Scientific title
The study of the simultaneous effect of therapeutic motion and heat therapy using Vanda apparatus on the extent of motion and muscle stiffness of patients in the intensive care unit
Public title
The study of the simultaneous effect of therapeutic motion and heat therapy using Vanda apparatus on the extent of motion and muscle stiffness of patients in the intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been admitted to ICU and need Home Care due to a general condition. Patient Family Satisfaction. Good general condition for the patient.
Exclusion criteria:
Congenital Musculoskeletal Disorders Acute cardiovascular disease
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 38
Actual sample size reached: 38
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization of coin toss
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
Tehran university of medical silences, Imam khomeini hospital complex
Street address
Kershavarz Blvrd
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2018-01-10, 1396/10/20
Ethics committee reference number
IR.TUMS.IKHC.REC.1396.4188

Health conditions studied

1

Description of health condition studied
Muscle stiffness in patients of intensive care units
ICD-10 code
(M00-M99)
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue

Primary outcomes

1

Description
Lower limb muscles length
Timepoint
The beginning of the study and 21 days later
Method of measurement
Standard goniometer

Secondary outcomes

1

Description
Changes in lower limb edema
Timepoint
The beginning of the study and 21 days later
Method of measurement
Standard goniometer

Intervention groups

1

Description
Intervention group: Patients after motion and heat therapy
Category
Treatment - Devices

2

Description
Control group: Patients without motion and heatTherapy
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital
Full name of responsible person
mokhtari rasoul
Street address
3km after Ravand Road - Doctor Blvd.
City
isfahan
Province
Isfehan
Postal code
81151/87159
Phone
+98 31 3452 1109
Email
mokhtarirasul@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Habobollah Dashti
Street address
Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1543
Email
habibdasht@gmail.com
Grant name
Grant code / Reference number
96-01-205-31895
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Habibolah Dashti
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Practitioner
Street address
Imam khomeini hospital complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2290
Fax
Email
habibdasht@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Habibolah Dashti
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Practitioner
Street address
Imam khomeini hospital complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2290
Fax
Email
habibdasht@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Habibolah Dashti
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Practitioner
Street address
Imam khomeini hospital complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2290
Fax
Email
habibdasht@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
When the data will become available and for how long
To whom data/document is available
Under which criteria data/document could be used
From where data/document is obtainable
What processes are involved for a request to access data/document
Comments
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