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Comparison of six weeks of virtual reality rehabilitation system and reflexology massage on neuropathic pain and performance of athletes with paraplegia

Protocol summary

Study aim
Comparison of the effect of six weeks of virtual reality rehabilitation system and reflexology massage on neuropathic pain intensity, pain time pattern, pain effects, fatigue rate, isometric strength and range of motion of shoulder girdle muscles in paraplegic athletes
Design
Clinical trial with control group and 2 intervention groups in a non-blind, non-random manner on 45 paraplegic athletes
Settings and conduct
After selecting the subjects, the relevant questionnaires (ISCIPDS ,FFS,demographic information) will be provided to the subjects. Both reflexology and virtual reality massage interventions will be performed for 6 weeks and 3 sessions per week. In the virtual reality group, the total training time will be 50 minutes, which will be 20 minutes for cooling and warming up, and 30 minutes for playing the desired games, and in the massage group, the massage people will receive the desired points for 30 minutes. The exercises of the virtual reality group will be performed in the desired club with the complete control of the researcher, and for the massage group, it will be performed on the spot by an expert with a degree from the Sports Medicine Federation.
Participants/Inclusion and exclusion criteria
People have paraplegia A history of exercising regularly for at least the last six months Having neuropathic pain History of more than 6 months of paraplegia Do not use painkillers to reduce neuropathic pain Not participating in any similar activity that affects pain and performance during the research project Having a psychological illness that has an obvious effect.
Intervention groups
We will have 3 intervention groups with the titles of virtual reality, reflexology massage and control.
Main outcome variables
Neuropathic pain; Performance; Fatigue; Isometric power; Range of motion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210924052562N1
Registration date: 2021-10-30, 1400/08/08
Registration timing: registered_while_recruiting

Last update: 2021-10-30, 1400/08/08
Update count: 0
Registration date
2021-10-30, 1400/08/08
Registrant information
Name
behnaz pour jafari jorjafaki
Name of organization / entity
The Shahid beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 34 3422 2500
Email address
b.porjafarijorjafaki@mail.sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-29, 1400/07/07
Expected recruitment end date
2021-12-31, 1400/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of six weeks of virtual reality rehabilitation system and reflexology massage on neuropathic pain and performance of athletes with paraplegia
Public title
The effect of massage and virtual reality system on neuropathic pain and function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People have paraplegia A history of exercising regularly for at least the last six months Having neuropathic pain History of more than 6 months of paraplegia
Exclusion criteria:
Taking painkillers to reduce neuropathic pain Participate in any similar activity that affects pain and performance during the research project drug use Having a psychological illness that has an obvious effect
Age
From 30 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethic Committees Of Shahid Beheshti univercity
Street address
Velenjak, Daneshjo Blvd
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2021-03-13, 1399/12/23
Ethics committee reference number
IR.SBU.REC.1400.072

Health conditions studied

1

Description of health condition studied
Paraplegia
ICD-10 code
G82.2
ICD-10 code description
Paraplegia

Primary outcomes

1

Description
Neuropathic pain
Timepoint
The effect of virtual reality exercises and massage on pain is measured before the intervention and 6 weeks after the start.
Method of measurement
The International Spinal Cord Injury Pain Basic Data Set questionnaire will be used for pain.

2

Description
fatigue
Timepoint
The effect of virtual reality exercises and massage on fatigue is measured before the intervention and 6 weeks after the start.
Method of measurement
The Fatigue Severity Scale questionnaire for fatigue

3

Description
isometric strength
Timepoint
The effect of virtual reality exercises and massage onisometric strength is measured before the intervention and 6 weeks after the start.
Method of measurement
The MMT device will be used to measure isometric power.

4

Description
range of motion
Timepoint
The effect of virtual reality exercises and massage on Range of Motion is measured before the intervention and 6 weeks after the start.
Method of measurement
The Mobee Med device will be used to measure range of motion.

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: virtual reality. The first group performs 30 minutes of virtual reality exercises for 3 sessions per week for 6 weeks.
Category
Rehabilitation

2

Description
Intervention group 2: Reflexology massage.The Reflexology group performs 30 minutes of Reflexology massage for 3 sessions per week for 6 weeks.
Category
Rehabilitation

3

Description
control group. No intervention is performed in this group.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Veterans and Disabled Sports Board of Tehran Province
Full name of responsible person
Mansour Nam Nam
Street address
Velenjak,Daneshjo Blvd
City
Tehran
Province
Tehran
Postal code
۱۹۸۳۹۶۹۴۱۱
Phone
+98 34 3422 0593
Email
behnaz_jafari10@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The Shahid Beheshti University
Full name of responsible person
Fariborz Hovanloo
Street address
Velenjak, Daneshjo Blvd
City
Tehran
Province
Tehran
Postal code
۱۹۸۳۹۶۹۴۱۱
Phone
+98 34 3422 0593
Email
behnaz_jafari10@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Shahid Beheshti University
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
The Shahid Beheshti University
Full name of responsible person
Behnaz pourjafari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports Injury And Corrective Movements-sports Rehabilitation
Street address
Velenjak, Daneshjo Blvd
City
Tehran
Province
Tehran
Postal code
۱۹۸۳۹۶۹۴۱۱
Phone
+98 34 3422 0593
Email
behnaz_jafari10@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The Shahid Beheshti University
Full name of responsible person
Behnaz Pourjafari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports Injury And Corrective Movements-sports Rehabilitation
Street address
Velenjak, Daneshjo Blvd
City
Tehran
Province
Tehran
Postal code
۱۹۸۳۹۶۹۴۱۱
Phone
+98 34 3422 0593
Email
behnaz_jafari10@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The Shahid Beheshti University
Full name of responsible person
Behnaz Pour jafari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Injury And Corrective Exersice-sports Rehabilitation
Street address
Velenjak, Daneshjo Blvd
City
Tehran
Province
Tehran
Postal code
۱۹۸۳۹۶۹۴۱۱
Phone
+98 34 3422 0593
Email
behnaz_jafari10@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the information about the original or similar results can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Accessible to researchers working in academic institutions and therapists
Under which criteria data/document could be used
It can be used to evaluate the ability to generalize the results to the disabled and patients considered by the researcher or therapist.
From where data/document is obtainable
To receive information, send an email to the following email address: behnaz_jafari10@yahoo.com
What processes are involved for a request to access data/document
After sending the e-mail to the relevant e-mail address, the information will be sent to the person within 14 days after ensuring that the person is a researcher and therapist.
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