The combined effect of Proprioceptive Neuromuscular Facilitation Exercises and mirror therapy on Balance and Pain intensity in incompelete traumatic spinal cord injury patients
Determine the effect of Proprioceptive Neuromuscular Facilitation Exercises and mirror therapy on Balance and Pain intensity in incompelete traumatic spinal cord injury patients
Design
A clinical trial with a control group, with parallel, randomized groups, will be performed on 60 patients.
Settings and conduct
The mentioned exercises will be performed in a suitable hall with the facilities and conditions required for the intervention. The exercises are for six weeks and two sessions per week; Each workout lasts about 30 to 45 minutes between 10 and 11 in the morning. Immediately after the sessions, the balance and pain intensity of patients will be assessed using relevant questionnaires. The place of intervention will be in Shahid Muftah Clinic.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diagnosis of spinal cord injury By a neurologist
6 months have passed From spinal cord injuries
Patient balance with a cut-off point score of less than 33 based on the Berg balance questionnaire
Having the physical ability to participate in sports exercises Based on the opinion of a doctor
No concomitant diseases (heart, lung and neurological disorders) Consent to participate in the study
Intervention groups
Control group: No training will be provided.
The first intervention group for neuromuscular facilitation exercises (PNF),
The second intervention group for mirror therapy exercises and
The third intervention group to practice both techniques simultaneously
Main outcome variables
Pain intensity / Balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220607055092N1
Registration date:2022-07-09, 1401/04/18
Registration timing:registered_while_recruiting
Last update:2022-07-09, 1401/04/18
Update count:0
Registration date
2022-07-09, 1401/04/18
Registrant information
Name
daniel bahrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4628 3738
Email address
daniel.bahrami@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-09, 1401/04/18
Expected recruitment end date
2022-08-19, 1401/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The combined effect of Proprioceptive Neuromuscular Facilitation Exercises and mirror therapy on Balance and Pain intensity in incompelete traumatic spinal cord injury patients
Public title
The combined effect of Proprioceptive Neuromuscular Facilitation Exercises and mirror therapy on Balance and Pain intensity in incompelete traumatic spinal cord injury patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of spinal cord injury By a neurologist
6 months have passed From spinal cord injuries
Patient balance with a cut-off point score of less than 33 based on the Berg balance questionnaire
Having the physical ability to participate in sports exercises Based on the opinion of a doctor
No concomitant diseases (heart, lung and neurological disorders)
Consent to participate in the study
Exclusion criteria:
disinclination to continue attending the study
Leave the exercises for more than two sessions
Cervical disc, lumbar disc and orthopedic problems
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
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
Ethics Committee of Yasouj University of Medical Sciences
Street address
First Floor Hazrat Zeinab School of Nursing; Yasuj University of Medical Sciences; Next to Imam Sajjad Hospital; Yasuj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Approval date
2022-05-18, 1401/02/28
Ethics committee reference number
IR.YUMS.REC.1401.007
Health conditions studied
1
Description of health condition studied
Spinal cord injuries
ICD-10 code
S34
ICD-10 code description
Injury of lumbar and sacral spinal cord and nerves at abdomen, lower back and pelvis level
Primary outcomes
1
Description
Balance score on the Berg balance questionnaire
Timepoint
Before the intervention and after each training session (12 sessions)
Method of measurement
Berg balance questionnaire
2
Description
Pain intensity based on visual analogue scale
Timepoint
Before the intervention and after each training session (12 sessions)
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: No content will be provided to the Control group
Category
Rehabilitation
2
Description
Intervention group: Neuromuscular facilitation (PNF) exercises will be performed for 12 sessions.
Category
Rehabilitation
3
Description
Intervention group:Mirror therapy exercises will be performed for 12 sessions.
Category
Rehabilitation
4
Description
Intervention group: Neuromuscular facilitation exercises (PNF) and mirror therapy exercises will be performed in combination for 12 sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofteh Clinic
Full name of responsible person
Daniel Bahrami
Street address
next to Shahid Beheshti Hospital; Yasuj County; Kohkiluyeh and Boyer Ahmad Province
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3322 8213
Email
daniel.bahrami@yums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sied Amin Hosseini Motlagh
Street address
First Floor Hazrat Zeinab School of Nursing; Next to Imam Sajjad Hospital; Yasuj University of Medical Sciences; Yasuj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 5140
Email
daniel.bahrami@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Sima Mohammadhoseini
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
First Floor Hazrat Zeinab School of Nursing; Next to Imam Sajjad Hospital; Yasuj University of Medical Sciences; Yasuj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 4115
Email
hossini3270@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sima Mohammadhoseini
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
First Floor Hazrat Zeinab School of Nursing; Next to Imam Sajjad Hospital; Yasuj University of Medical Sciences; Yasuj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 4115
Email
hossini3270@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sima Mohammadhoseini
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
First Floor Hazrat Zeinab School of Nursing; Next to Imam Sajjad Hospital; Yasuj University of Medical Sciences; Yasuj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 4115
Email
hossini3270@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available