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Comparison of the effect of a Proprioceptive Neuromuscular Facilitation (PNF)-based virtual reality intervention versus real PNF exercises on motor, cognitive and occupational performance in chronic stroke survivors

Protocol summary

Study aim
Comparison of the effect of a Proprioceptive Neuromuscular Facilitation (PNF)-based virtual reality intervention versus real PNF exercises on motor, cognitive, mood (depression and anxiety) and occupational performance in chronic stroke survivors
Design
A single blind clinical trial with parallel groups, 28 samples from chronic stroke survivors, Randomization through a table of random numbers and the method of classified random blocks
Settings and conduct
Chronic stroke patients are enrolled in the study based on the inclusion criteria and by giving informed consent. After the initial assessments, participants are randomly assigned to PNF-based virtual reality intervention group and real PNF exercises group and receive an 8-week occupational therapy services at Mowafaghian Smart Rehabilitation Center. Then the final evaluation and after 1month follow-up evaluation will be done
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range18 to 64 years, First stroke, 6 months to a maximum of 4 years since stroke, Ability to sit independently on a chair, Ability to understand and follow instructions, Brunnstrom stage 3 or higher for upper extremity؛ Exclusion criteria criteria: severe visual impairment, history of previous mood disorders or use of related medications
Intervention groups
The participants are randomly assigned to the PNF-based virtual reality intervention group and the real PNF exercises group. At first of each session, participants in both groups receive conventional occupational therapy for 30minutes.Then, the participants in the PNF-based virtual reality intervention group perform exercises based on the PNF approach through the virtual reality system for 30minutes,and the other group performs the same exercises in the real therapy environment for 30minutes
Main outcome variables
Upper Extremity motor performance, cognitive performance, occupational performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240406061422N1
Registration date: 2024-08-05, 1403/05/15
Registration timing: registered_while_recruiting

Last update: 2024-08-05, 1403/05/15
Update count: 0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
Fatemeh Sadat Hosseini Ramshe
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1721
Email address
fatemehosseini@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of a Proprioceptive Neuromuscular Facilitation (PNF)-based virtual reality intervention versus real PNF exercises on motor, cognitive and occupational performance in chronic stroke survivors
Public title
Comparison of the effect of a Proprioceptive Neuromuscular Facilitation (PNF)-based virtual reality intervention versus real PNF exercises in stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
First stroke experience A minimum of 6 months to a maximum of 4 years since stroke Ability to sit independently on a chair during the intervention Ability to understand and follow instructions Brunnstrom stage 3 or higher for upper extremity
Exclusion criteria:
Severe visual impairment that makes it difficult to interact with virtual reality tool History of previous mood disorders or use of related medications
Age
From 18 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
Considering the impact of gender on some of the variables, participants are initially divided into two categories based on gender. Then, within each category, patients are randomly assigned in equal numbers to one of two intervention groups ,PNFbased virtual reality intervention group and the real PNFexercises group, using block randomization of size 4.The criterion for choosing each of the 6 possible block states is rolling a dice. That is, two patients out of4similar patients are assigned to the intervention group in the virtual environment and the other two are assigned to the real exercise group. This process continues until the patients are grouped by gender into two homogeneous groups and, additionally, the numbers in both groups are made equal.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluation process will be performed by another master's student with clinical experience in patients with neurological disorders, who is not aware of how patients are assigned to groups
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Near Taleghani hospital, Arabi Street, Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2023-11-12, 1402/08/21
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.437

Health conditions studied

1

Description of health condition studied
Chronic Stroke Survivors
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction

Primary outcomes

1

Description
Upper Extremity motor performance
Timepoint
Pre ,Post, After 1 month follow up
Method of measurement
Fugl-Meyer Assessment, Motor Activity Log

2

Description
Cognitive performance
Timepoint
Pre ,Post, After 1 month follow up
Method of measurement
Montreal Cognitive Assessment, Wisconsin Card Sorting Test ,Forward and backward Digit Span Test

3

Description
Occupational performance
Timepoint
Pre ,Post, After 1 month follow up
Method of measurement
Canadian Occupational Performance Measure

Secondary outcomes

1

Description
Depression and Anxiety
Timepoint
Pre, Post, After 1 month follow up
Method of measurement
Hospital Anxiety and Depression Scale

Intervention groups

1

Description
Intervention group: Participants in the Proprioceptive Neuromuscular Facilitation (PNF)-based virtual reality intervention group receive 24 sessions of intervention over 8 weeks. At the first of each session, they receive conventional interventions for 30 minutes. Then, they also receive a 30-minute PNF intervention through the smart rehabilitation system Sana at the Mowafaghian rehabilitation center. The kinetic camera of this virtual reality tool determines the joint angles of the patient and presents them as an avatar on the screen, providing one-handed and two-handed exercises in the form of reaching, tracking, and rotation scenarios. These exercises are designed based on diagonal patterns of the upper limbs in PNF approach. Colorful balls of various sizes appear as targets on the screen during the exercises, and the patients follow PNF patterns to complete the exercises. The precision, repetition, and speed of exercise are adjusted according to the therapist's opinion and the patient's progress. Additionally, appropriate auditory and visual feedback is received through the screen based on the individual's performance during the exercises.
Category
Rehabilitation

2

Description
Control group: Participants in the real Proprioceptive Neuromuscular Facilitation (PNF) exercises group will receive 24 sessions of occupational therapy intervention over 8 weeks, and receive 30 minutes of conventional occupational therapy interventions at the first of each session. They will then perform the same PNF-based exercises in a real manner for 30 minutes. Balls will be used to simulate scenarios of virtual reality tools in the therapeutic environment, and in the same form of reaching, tracking, and rotation scenarios the ball in diagonal patterns of the upper limbs in PNF approach will be executed by the patients. The precision, repetition, and speed of exercise will be adjusted according to the therapist's opinion and the patient's progress, and feedbacks provide by the therapist.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Occupational Therapy Clinic, School of Rehabilitation Sciences, Shahid Beheshti University of Medica
Full name of responsible person
Dr Mahnaz Hejazi
Street address
School of Rehabilitation Sciences Shahid Beheshti University of Medical Sciences, in front of Bu Ali Hospital, Damavand Street
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7715 9535
Email
m.hejazishirmard@yahoo.com

2

Recruitment center
Name of recruitment center
Dr Javad Mowafaghian Research Center
Full name of responsible person
Dr Mahnaz hejazi
Street address
No. 11, Khark Street, Enghelab Street, Tehran
City
Tehran
Province
Tehran
Postal code
11339-13813
Phone
+98 21 6671 6100
Email
m.hejazishirmard@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Shahid Arabi St,Yemen St, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hosseini Ramshe
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences, in front of Bu Ali Hospital, Damavand St, Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Fax
Email
fatemehosseini@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mahnaz Hejazi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation Sciences Shahid Beheshti University of Medical Sciences, in front of Bu Ali Hospital, Damavand St, Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
m.hejazishirmard@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hosseini Ramshe
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences, in front of Bu Ali Hospital, Damavand St, Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Fax
Email
fatemehosseini@sbmu.ac.ir

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
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
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information related to primary and secondary outcomes
When the data will become available and for how long
After publishing the articles
To whom data/document is available
Researchers intending to research in this field
Under which criteria data/document could be used
Obtaining written permission from the research team, Mention the source of information
From where data/document is obtainable
- Fatemeh Sadat Hosseini Ramshe : School of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences, Damavand St, Imam Hossein Square. Email Adress: fatemehosseini@sbmu.ac.ir , - Dr Mahnaz Hejazi Shirmard : School of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences, Damavand St, Imam Hossein Square. Email Adress: :M.hejazishirmard@yahoo.com
What processes are involved for a request to access data/document
After sending the email to the researcher and requesting the document, the researcher will request the opinion of other members of the research team regarding the provision of this information and, if the members agree, the documents will be sent as soon as possible but sending the documents requires the acceptance of the criteria mentioned above.
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