Protocol summary

Study aim
Study aims to evaluate the Effect of Proprioceptive Neuromuscular Facilitation Patterns to Improve Gait and Balance in Acute, Sub-acute and Chronic Hemiplegic stroke Patients.
Design
Interventional quantitative study
Settings and conduct
Al-khidmat hospital Tehseen hospital sheikh zayed hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 55-70 years. Both genders (male and female). Patients with diagnosis of hemorrhagic and ischemic stroke. Patients (with minimum support) were able to walk 10 meter Exclusion Criteria • Patient with preexisting medical conditions like cardiac disease (coronary or peripheral artery disease, cardiomyopathy) respiratory disease(asthma, pneumonia and lung cancer etc.) neurological condition (epilepsy, headache, seizures, spinal cord injury) or orthopedic diagnosis (OA, RA, CTS etc.) that could interfere training protocol • Patient who are unable to do training program. • Patients who are involved in any kind of other physical therapy or medical treatment.
Intervention groups
Treatment group received rhythmic initiation, treadmill with thera band and PNF Active control group recieved rhythmic initiation, treadmill with thera band
Main outcome variables
Time Up and Go test Performance-Oriented Mobility Assessment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210827052300N1
Registration date: 2021-10-22, 1400/07/30
Registration timing: retrospective

Last update: 2021-10-22, 1400/07/30
Update count: 0
Registration date
2021-10-22, 1400/07/30
Registrant information
Name
Arwa Tahir
Name of organization / entity
The University Of Faisalabad
Country
Pakistan
Phone
+92 68 5878962
Email address
dpt-fa14-030@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-19, 1400/02/29
Expected recruitment end date
2021-07-07, 1400/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EFFECT OF PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION PATTERNS TO IMPROVE GAIT AND BALANCE IN ACUTE SUB-ACUTE AND CHRONIC HEMIPLEGIC STROKE PATIENTS
Public title
EFFECT OF PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION PATTERNS TO IMPROVE GAIT AND BALANCE IN ACUTE, SUB-ACUTE AND CHRONIC HEMIPLEGIC STROKE PATIENTS
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
 Age 55-70 years.  Both genders (male and female).  Patients with diagnosis of hemorrhagic and ischemic stroke.  Patients were able to walk 10 meter (with minimum support) (Kim and Kim,2018) . Patients with acute, sub acute and chronic hemiplegic stroke.  Patients who are willing to participate.
Exclusion criteria:
 Patient with preexisting medical conditions like cardiac disease (coronary or peripheral artery disease, cardiomyopathy) respiratory disease(asthma, pneumonia and lung cancer etc.) neurological condition (epilepsy, headache, seizures, spinal cord injury) or orthopedic diagnosis (OA, RA, CTS etc.) that could interfere training protocol (Veneri, 2011).  Patient who are unable to do training program.  Patients who are involved in any kind of other physical therapy or medical treatment.
Age
From 55 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Lottery method were used. names of the participants were written on piece of paper and put them in a box and chosen randomly for both groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blinded study. only the investigator knows the control or treatment group others were unaware.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical and technical committee of the university of faisalabad
Street address
Sargodha road faisalabad
City
Faisalabad
Postal code
38000
Approval date
2021-05-15, 1400/02/25
Ethics committee reference number
TUF/DR/MSPP/304

Health conditions studied

1

Description of health condition studied
Stroke of all of 3 stages acute subacute and chronic due to ischemia and hemorrhage
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Time up and go test and Performance oriented mobility assessment scale
Timepoint
at baseline , at 12 session and at the end of treatment session
Method of measurement
For time up and go test stopwatch and chair was required and for poma scale instructions follwed according to their mention points

Secondary outcomes

empty

Intervention groups

1

Description
Control group, received only treadmill training with thera band and rythmic initiation were performed as warm up and cool down
Category
Rehabilitation

2

Description
Intervention group: rythmic initiation were performed as warm up and cool down, treadmill training with thera band and proprioceptive neuromuscular facilitation was performed.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Sheikh zayed hospital
Full name of responsible person
Head of department Dr usman yousaf, Dr fouzia nwaz
Street address
Hospital road SZH
City
Rahim yar khan
Postal code
64200
Phone
+92 68 9230168
Email
Info@szmc.edu.pk
Web page address
Http://www.szmc.edu.pk/

2

Recruitment center
Name of recruitment center
Al khidmadt medical complex
Full name of responsible person
Dr usman yousaf
Street address
Trust colony
City
Rahim yar khan
Postal code
64200
Phone
+92 68 5877084
Email
Akfmcryk@gmail.com
Web page address
Https://g.co/kgs/SR41Be

3

Recruitment center
Name of recruitment center
Tehseen hospital
Full name of responsible person
Dr Ghulam tehseen
Street address
Wireless pull
City
Rahim yar khan
Postal code
64200
Phone
+92 68 5881813
Email
Uzairtahseen1@gmail.com
Web page address
Https://m.facebook.com/pages/Tehseen-Hospital-Rahim-Yar-Khan/162450107644926

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Head of department and supervisor Dr marium zafar
Street address
Sargodha road
City
Rahim yar khan
Postal code
38000
Phone
+92 41 8868326
Fax
+92 41 8868220
Email
Dpt-fa14-030@tuf.edu.pk
Web page address
https://tuf.edu.pk/
Grant name
head of department
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Faisalabad
Proportion provided by this source
100
Public or private sector
Private
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 University of Faisalabad
Full name of responsible person
Arwa Tahir
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Sargodha road
City
Rahim yar khan
Province
Punjab
Postal code
38000
Phone
+92 41 8868326
Fax
+92 41 8868220
Email
Studentaffairshsw@tuf.edu.pk
Web page address
Https://tuf.edu.pk/

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Arwa Tahir
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Sargodha road
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8868326
Fax
+92 41 8868220
Email
Studentaffairshsw@tuf.edu.pk
Web page address
Https://tuf.edu.pk/

Person responsible for updating data

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Arwa Tahir
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Sargodha road
City
Rahim yar khan
Province
Punjab
Postal code
38000
Phone
+92 41 8868326
Fax
+92 41 8868220
Email
Dpt-fa14-030@tuf.edu.pk
Web page address
https://tuf.edu.pk/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
the data of the patients can not be shared as mentioned in consent form
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
only the data related to measuring outcome would be shared no personal information will be shared
When the data will become available and for how long
2022
To whom data/document is available
everyone related to our field
Under which criteria data/document could be used
only email id
From where data/document is obtainable
from email
What processes are involved for a request to access data/document
email id
Comments
no comments
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