Checking the level of satisfaction of physiotherapists after using the manufactured product
Design
Clinical trial with intervention group on 20 patients
Settings and conduct
This study will be conducted in Kausar Medical Research Training Center located in Semnan city. During this study, neurological patients admitted to the hospital who need to be set up and rehabilitated will be moved and carried by the physiotherapist in a safe and comfortable manner, and finally the level of satisfaction will be measured.
Participants/Inclusion and exclusion criteria
Conditions for entering patients:
1) Age 18 to 60 years of both sexes
2) Medical condition with stable cardiopulmonary vital signs
3) The state of consciousness of the patient should be 13 or higher on the Glasgow Coma Scale.
4) The request of the attending physician to start the patient
5) Patients with stable neurological conditions
6) Normal body mass index (19 to 25)
7) Willingness of the patient in order to start
8) Verbal communication by the patient
- Patient discharge conditions:
1) Patients with acute or chronic back pain that interferes with their starting.
2) spinal canal stenosis
3) spine and hip surgery in the last 3 months
4) Non-cooperation of the patient in order to start
5) Severe edema of the lower limbs
Intervention groups
Neurological patients who need to be set up and rehabilitated who are hospitalized in the hospital wards are set up by the physiotherapist with the help of the manufactured product during the rehabilitation period.
Main outcome variables
Checking the level of satisfaction using a researcher-made questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230712058751N1
Registration date:2023-08-18, 1402/05/27
Registration timing:prospective
Last update:2023-08-18, 1402/05/27
Update count:0
Registration date
2023-08-18, 1402/05/27
Registrant information
Name
Parisa Arzani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4181
Email address
parisa_arzani@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-09, 1402/06/18
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, Manufacture and production of rehabilitation aid belt for Neurological Patients
Public title
Design, Manufacture and production of rehabilitation aid belt for Neurological Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years of both sexes
Medical condition with stable cardiopulmonary vital signs
The state of consciousness of the patient should be 13 or higher on the Glasgow Coma Scale.
The request of the attending physician to start the patient
Patients with stable neurological conditions
Normal body mass index
Willingness of the patient in order to start
Verbal communication by the patient
Exclusion criteria:
Patients with acute or chronic low back pain that interferes with starting.
Spinal stenosis
Spine and hip surgery in the last 3 months
Non-cooperation of the patient in order to start
Severe edema of the lower limbs
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Semnan University Of Medical Sciences and Health Services
Street address
Semnan university of medical sciences complex, Physiotherapy department
City
Semnan
Province
Semnan
Postal code
3614773943
Approval date
2023-06-25, 1402/04/04
Ethics committee reference number
IR.SEMUMS.REC.1402.076
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
2
Description of health condition studied
Parkinson
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
3
Description of health condition studied
multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Checking the level of satisfaction of physiotherapists or using a researcher-made questionnaire
Timepoint
21 days after the intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment in the intervention group will include the use of a support belt produced for the safe and comfortable transportation of patients who need to be set up. The patient, under the supervision of the physiotherapist, will be moved and transferred during the day with the help of the produced belt with the aim of starting and rehabilitation in the hospital.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kausar Semnan Medical Research Training Center
Full name of responsible person
Javad Hadadi
Street address
Kausar educational research and treatment center, Golestan town, Semnan, Semnan Province, Iran
City
semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 0115
Fax
Email
kosarhos@semums.ac.ir
Web page address
https://kosarhos.semums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Majid Mirmohammadkhani
Street address
Basij Blvd., Semnan University of Medical Sciences and Health Services Headquarters, Research and Technology Vice-Chancellor