The Effect of Proprioceptive Neuromuscular Facilitation Exercise on Quality of Life in Patients with Stroke
Design
Clinical trials with control group, Community based, With parallel groups, Not blind, Non-random
Settings and conduct
Satisfactory informed and written consent is obtained from eligible people who are willing to participate in the research. First, the quality of life is measured in both groups,then, the intervention is implemented. No action is taken in the control group. Immediately and 4 weeks after completing the exercises, quality of life will be measured in both groups.Exercises are done in the homes of patients
Participants/Inclusion and exclusion criteria
Inclusion: Personal and informed consent, Over 4 months to 2 years after stroke, Age more than 60 to 90 years, Once affected by stroke, The absence of spinal cord lesions, Lack of other chronic diseases, such as orthopedic and neurological diseases, Ability to communicate and answer questions
Exclusion: Inability to communicate; Non-Residential in Yasuj; Passed less than 4 months and more than 2 years of stroke; Age less than 60 and more than 90 years
Intervention groups
ntervention: Proprioceptive neuromuscular facilitation exercise program are performed for 8 weeks and two sessions each week for 30-45 minutes based on the protocol in the intervention group.In this study, two motor patterns of upper and lower limbs are used. The first stage: A passive stretching or active within 10 to 20 seconds actions and target muscles gently used gradually the end range of motion. Second stage: Immediately or after a break of about 2 to 3 seconds of contraction unlike the therapist takes place.Third stage: Immediately or after a pause of about 2 to 3 seconds again to reach the target muscles twitching find a new point of range of motion.
Control:There is no intervention in the control group.
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160430027676N2
Registration date:2018-10-30, 1397/08/08
Registration timing:retrospective
Last update:2018-10-30, 1397/08/08
Update count:0
Registration date
2018-10-30, 1397/08/08
Registrant information
Name
Yaghoub Parandvar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 4721
Email address
yaghoub.parandvar@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Proprioceptive Neuromuscular Facilitation (PNF) on Quality of Life (QOL) of Patients with Stroke
Public title
The Effect of Proprioceptive Neuromuscular Facilitation (PNF) on Quality of Life (QOL)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Personal and informed consent to attend the study
Over 4 months to 2 years after stroke
Definitive diagnosis of stroke by a neurologist
Age more than 60 years to 90 years
Once affected by stroke
The absence of spinal cord lesions
Failure to receive Proprioceptive Neuromuscular Facilitation Technique from 6 months ago
Lack of other chronic diseases, such as orthopedic and neurological diseases
Ability to communicate and answer Persian questions
Residence in Yasuj
Exclusion criteria:
Disruption of the cognitive, alert and mental state of the patient
Age more than 90 years old
Age
From 60 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics Committee on Research, Yasuj University of Medical Sciences
Street address
Vice chancellor of research and technology, Yasuj University of Medical Sciences, Motahari Blvd,Yasouj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2018-08-04, 1397/05/13
Ethics committee reference number
IR.YUMS.REC.1397.057
Health conditions studied
1
Description of health condition studied
Cerebrovascular Accident
ICD-10 code
(I69.4)
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Quality of life for stroke patients
Timepoint
Before the intervention, Immediately after the intervention, 4 week after the intervention
Method of measurement
World Health Organization Quality of Life Short Form questioner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Proprioceptive neuromuscular facilitation exercise program was performed for 8 weeks and two sessions each week for 30-45 minutes (16 sessions within 2 months) based on the protocol and the relevant instruction in the intervention group. In this study, the pattern of motion of the arm (Upper Extremity ) and hip movement patterns (lower Extremity) are used.Patterns of the arm joint (upper extremity): D1 flexion pattern: Flexion, abduction, External rotation (elbow flexed and elbow extended). D1 extension pattern: Extension, adduction, internal rotation (elbow flexed and elbow extended). D2 flexion pattern: flexion, adduction, external rotation (elbow flexed and elbow extended). D2 extension pattern: extension, abduction, internal rotation (elbow flexed and elbow extended). Patterns of knee joint(lower extremity): D1 flexion pattern: Flexion, abduction, internal rotation (knee flexed and knee extended). D1 extension pattern: Extension, adduction, external rotation (knee flexed and knee extended). D2 flexion pattern: Flexion, adduction, external rotation (knee flexed and knee extended). D2 extension pattern: Extension, abduction, internal rotation (knee flexed and knee extended). The therapist first places the member in the position according to the three axes of motion. In this case, the muscles are drawn as far as possible (not up to the latest range of motion). The first step: A passive stretching or active within 10 to 20 seconds actions and target muscle or muscles gently used gradually the end range of motion.This situation is maintained for a while. Second stage: Immediately or after a break of about 2 to 3 seconds of contraction unlike the therapist takes place. The contract period is typically 3 to 6 seconds. Third stage: Immediately or after a pause of about 2 to 3 seconds again to reach the target muscle or muscle twitching find a new point of range of motion. Immediately and 4 weeks after the last session of the exercise, the quality of life of the patients will be measured.
Category
Rehabilitation
2
Description
Control group: Before intervention, immediately after the intervention and 4 weeks after the end of the intervention,the quality of life will be measured using the relevant questionnaire.There will be no intervention in the control group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Martyr Dr.Beheshti Hospital of Yasuj
Full name of responsible person
Dr.Hosseini Motlagh Amin
Street address
Martyr Dr.Beheshti Hospital, Martyr Mohammad Montazeri street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 4721
Fax
+98 74 3322 1811
Email
y.parandvar@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Marie oriad, Hossein
Street address
Yasouj University of Medical Sciences,Vice chancellor for research, motahari BLvd, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6079
Fax
+98 74 3334 6078
Email
y.parandvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yasouj University of Medical Sciences and Health Services
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
Parandvar Yaghoub
Position
Master science of Medical Surgical Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Department of ICU, Martyr Dr.Beheshti hospital , Martyr Mohammad Montazeri street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 4721
Fax
Email
y.parandvar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
parandvar yaghoub
Position
Master science of Medical Surgical Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Department of ICU, Martyr Dr.Beheshti hospital , Martyr Mohammad Montazeri street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 4721
Email
y.parandvar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Parandvar Yaghoub
Position
Master Science of Medical Surgical Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Martyr Mohammad Montazeri street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 4721
Email
y.parandvar@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
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