Determining and comparing the level of occupational performance and level of satisfaction in occupational performance of spinal cord injury patients before, after and one month after the intervention in the intervention and control groups
Design
A clinical trial single-blind, randomized
Settings and conduct
Online via Skyroom through the country's spinal cord injury associations
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ability to verbally communicate and speak in Persian, read and write Age between 18-60 years Have used one of the types of wheelchairs (electric or simple) for activity daily living at home or outdoors in the last 3 months No more than 3-5 years have passed since his injury or has never used rehabilitation training services. Patients with paraplegic spinal cord injury Functional ability to perform 8-10 push up exercises based on the video presented on the bed in a sitting position Ability to access and use the intelligent system and the Internet Ability and adequate time to participate in the intervention program independently Get a score higher than 22 on the MMSE cognitive test Exclusion criteria Reluctance to cooperate at any stage of the research Absence of more than one session in the training program.
Intervention groups
Participants were randomly divided into two groups of intervention and control. People in the intervention group had 4 2 hours sessions over 5 weeks through the Skyroom program: Transfer techniques, upper limb strengthening exercises, principles of adjustment and operation of all types of wheelchairs are taught. Participants in the intervention group will be trained and intervened in 4 small groups of 5-6 people.
Main outcome variables
Improve occupational performance, improve patient satisfaction with occupational performance
General information
Reason for update
Acronym
SCI
IRCT registration information
IRCT registration number:IRCT20211220053459N1
Registration date:2022-02-01, 1400/11/12
Registration timing:prospective
Last update:2022-02-01, 1400/11/12
Update count:0
Registration date
2022-02-01, 1400/11/12
Registrant information
Name
Fatemeh Motaharinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
fatemeh.motahari64@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-14, 1400/11/25
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of online wheelchair mobility and transfer training methods on performance level and satisfaction in people with spinal cord injuries
Public title
Effectiveness of online wheelchair mobility and transfer methods on performance level and satisfaction in spinal cord injuries
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to verbally communicate and speak in Persian, read and write
Age between 16-60 old
Use one of the types of wheelchairs (electric or simple) for daily activities at home or outdoors in the last 3 months
No more than 3-5 years have passed since their injury or have never used rehabilitation training services
Patients with spinal cord injury of paraplegic type
Functional ability to perform 8-10 push-up exercises in accordance with the video presented on the bed in a sitting position
Ability to access and use the intelligent system and the Internet
Ability and sufficient time to participate in the intervention program independently
Get a score above 22 on the MMSE cognitive test
Exclusion criteria:
Having serious psychological disturbances
Absent in more of a sessions
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
50 participants will be divided into two groups of intervention and control by Stratified Balanced Block Randomization with equal block method. Out of a maximum of 20 modes for the six blocks, three will be in the intervention group or A and three in the control group will be created using the RANDBETWEEN (1,20) command in Excel software. Participants will be divided equally into two groups according to the random sequence created.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome evaluator: The person or people who evaluate the outcome or non-outcome of the outcome in the participants or collect data on the outcome variables.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2022-01-28, 1400/11/08
Ethics committee reference number
IR.SEMUMS.REC.1400.270
Health conditions studied
1
Description of health condition studied
spinal cord injury
ICD-10 code
G82.2
ICD-10 code description
Paraplegia
Primary outcomes
1
Description
level of occupational performance and satisfaction of occupational performance
Timepoint
Before the intervention, after the intervention and one month after the intervention
Method of measurement
Canadian Occupational Performance Measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After filling out the written consent form and performing the evaluations, the interventions are performed in 4 sessions of 2 hours during 5 weeks as a group and online. Treatment and training include training in various techniques of transfer and transfer from wheelchair to bed, chair, toilet or bathroom chair, car, floor and vice versa, training in upper extremity strengthening exercises to perform transfers and principles of adjusting wheelchairs, braking lock And there will be a change in the position of the wheelchair and etc.
Category
Rehabilitation
2
Description
Control group: the control group will receive routine related to transfer and mobility principals and essential counseling, in a format of pamphlet or a booklet