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Effects of Proprioceptive Neuromuscular Facilitation Technique on Scapular Dyskinesis in Patients with Subacute Stroke

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History
# Registration date Revision Id
7 2023-11-25, 1402/09/04 287402
6 2023-11-22, 1402/09/01 286114
5 2023-11-06, 1402/08/15 286043
4 2023-10-18, 1402/07/26 283602
3 2023-10-16, 1402/07/24 282360
2 2023-10-11, 1402/07/19 281804
1 2023-10-10, 1402/07/18 281484
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
To see the effects of PNF Hold Relax technique on scapular dyskinesis in patients with subacute stroke and to compare the effects of D1 and D2 flexion patterns of proprioceptive neuromuscular facilitation on pain, range of motion, disability and scapular asymmetry in patients with subacute stroke
Design
randomized clinial design
Settings and conduct
Ibn-e-Siena Hospital & Research Institute, Multan.
Participants/Inclusion and exclusion criteria
Both male and female genders will be included patient having within range of 40-60 years the stage of stroke attack with onset at least 05 months patients developing unilateral scapular dyskinesis due to stroke assessed by lateral scapular slide test with type 1 scapular dyskinesia prominent infero-medial border of scapula will be in inclusion criteria patients with neurological deficit of the upper extremity patients with any surgery of upper extremity and Active Infections, Hyper mobility, Calcification of the soft tissues, fragile skin patients with Musculoskeletal injuries as upper limb fractures, dislocation, joint instability or any soft tissue injuries on affected side and Other illnesses such supraspinatus, bicep tendinitis, fibromyalgia, frozen shoulder and arthritis that produced discomfort in the upper extremities and Severe depression or other post-stroke symptoms, etc will be in exclusion criteria
Intervention groups
D1 flexion group and D2 flexion group named in intervention group
Main outcome variables
patients shoulder ROM will be measured Visual analogue scale to measure pain Shoulder pain and disability index will be measured

General information

Reason for update
Acronym
LSST, SPADI,ROM, SD
IRCT registration information
IRCT registration number: IRCT20230706058687N1
Registration date: 2023-10-10, 1402/07/18
Registration timing: registered_while_recruiting

Last update: 2023-10-10, 1402/07/18
Update count: 6
Registration date
2023-10-10, 1402/07/18
Registrant information
Name
Rafia Abdul Rehman
Name of organization / entity
The university of Faisalabad
Country
Pakistan
Phone
+92 307 7136100
Email address
2021-ms-pt-031@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-19, 1402/06/28
Expected recruitment end date
2023-10-19, 1402/07/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Proprioceptive Neuromuscular Facilitation Technique on Scapular Dyskinesis in Patients with Subacute Stroke
Public title
Effects of Proprioceptive Neuromuscular Facilitation Technique on Scapular Dyskinesis in Patients with Subacute Stroke
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients developing unilateral scapular dyskinesis due to stroke assessed by lateral scapular slide test Type 1 scapular dyskinesia prominent infero-medial border of scapula The 40-60 years of age, included both Male and Female Stroke with onset at least 05 months
Exclusion criteria:
Neurological deficit of the upper extremity Any surgery of upper extremity Active Infections, Hyper mobility, Calcification of the soft tissues, fragile skin Other illnesses such supraspinatus, bicep tendinitis, fibromyalgia, frozen shoulder and arthritis that produced discomfort in the upper extremities, etc Severe depression or other post-stroke symptoms, etc
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Consecutive allocation through lottery method
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
purposive sampling technique

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of the university of faisalabad
Street address
NO.P-11,ZEENAT BLOCK;MUSLIM TOWN1; FAISALABAD, PAKISTAN
City
Faisalabad
Postal code
14496-14535
Approval date
2023-03-24, 1402/01/04
Ethics committee reference number
TUF/DR/SA/MSPP/2023/250

Health conditions studied

1

Description of health condition studied
Sub-acute stage of stroke ( 3weeks to 6months)
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Visual Analogous Scale (VAS) was used instrument for assessing the characteristics of pain that a patient is experiencing
Timepoint
1,2,4 week
Method of measurement
this is gold standerd test having 0-10 measurement for mild, moderate, severe pain

2

Description
The patients shoulder's range of motion will be measured
Timepoint
1,2,4 week
Method of measurement
flexion, extension, abduction, internal rotation, and external rotation measured by using goniometr

Secondary outcomes

1

Description
Shoulder Pain and Disability evaluates pain as well as the other upper extremity functional activities shoulder pain and disability index had high reliability and validity values
Timepoint
1,2,4 week
Method of measurement
shoulder pain and disability index will measure it

Intervention groups

1

Description
Intervention group:
Category
Rehabilitation

2

Description
Intervention group:
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibn-e-Siena Hospital & Research Institute, Multan
Full name of responsible person
Prof.Dr.Sajid Rashid, PT
Street address
6HC8+P2H, Northern Bypass, Block A Model Town, Multan, Punjab
City
Multan
Postal code
60650
Phone
+92 300 6309825
Fax
+92 61 6782872
Email
sajid.rashid@mcpm.edu.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The university of Faisalabad
Full name of responsible person
Rafia Abdul Rehman
Street address
chungi no #6 itfaq colony rajpoot street house no16 boasan road multan
City
multan
Postal code
60700
Phone
+92 307 7136100
Email
rafiarehman096@gmail.com
Grant name
No
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
self funding
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
The university of Faisalabad
Full name of responsible person
Rafia Abdul Rehman
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
chungi no #6 itfaq colony rajpoot street house no16 boasan road multan
City
multan
Province
punjab
Postal code
60700
Phone
+92 307 7136100
Email
rafiarehman096@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Multan college of physiotherapy, multan
Full name of responsible person
prof. Dr. Sajid rashid,PT
Position
physiotherapist
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
6HC8+P2H, Northern Bypass, Block A Model Town, Multan, Punjab
City
multan
Province
punjab
Postal code
60700
Phone
+92 300 6309825
Email
sajid.rashid@mcpm.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
The university of Faisalabad
Full name of responsible person
Rafia Abdul Rehman
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
chungi no #6 itfaq colony rajpoot street house no16 boasan road multan
City
multan
Province
punjab
Postal code
60700
Phone
+92 307 7136100
Email
rafiarehman096@gmail.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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Effects of Proprioceptive Neuromuscular Facilitation Technique on Scapular Dyskinesis in Patients with Subacute Stroke
When the data will become available and for how long
data will be available for other people almost 6 months after the completion of study
To whom data/document is available
data will be available for other people almost 6 months after the completion of study
Under which criteria data/document could be used
The data/document could be used by communicating with the principle investigator Rafia Abdul Rehman; email rafiarehman096@gmail.com
From where data/document is obtainable
Rafia Abdul Rehman; Gmail rafiarehman096@gmail.com
What processes are involved for a request to access data/document
The data/document could be used by communicating with the principle investigator Rafia Abdul Rehman; Gmail rafiarehman096@gmail.com
Comments
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