To study the effects of oculogyration with neck proprioceptive neuromuscular facilitation patterns on trunk stabilization and standing balance in subacute stroke patients.
Design
Randomized Clinical Trial, Single Blind
Settings and conduct
Allied Hospital Faisalabad, Aziz Fatima Hospital Faisalabad and District Head Quarter (DHQ) Hospital Faisalabad.
Participants/Inclusion and exclusion criteria
Inclusion criteria includes patients with first stroke attack, patients with subacute stroke, Post stroke duration three to six months, Age between 40-65 years, Both male and female, patients with unilateral hemiplegia, patients without any visual disorder, Patients without any hearing disorder, patients with greater than fair strength of extensor and flexors muscles of neck, patients with greater than 3 points on functional ambulation classification, Patients with more than twenty-four points on mini mental state examination.
Exclusion criteria includes patients with cognitive impairment, patients with half blindness and hemineglect, patients with Oculomotor nerve defect, Patients with any neurological degenerative disease and patient with any musculoskeletal impairment which affect standing balance.
Intervention groups
Group A will recieve oculogyration (eye movement exercises) with neck proprioceptive neuromuscular facilitation patterns.
Group B will recieve oculogyration (eye movement exercises).
Main outcome variables
Trunk Stabilization
Standing Balance
General information
Reason for update
Acronym
PNF (Proprioceptive Neuromuscular Facilitation)
IRCT registration information
IRCT registration number:IRCT20230502058048N1
Registration date:2023-08-09, 1402/05/18
Registration timing:registered_while_recruiting
Last update:2023-08-09, 1402/05/18
Update count:0
Registration date
2023-08-09, 1402/05/18
Registrant information
Name
Kainat Idrees
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8750971
Email address
2021-ms-pt-068@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-24, 1402/05/02
Expected recruitment end date
2023-09-30, 1402/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EFFECTS OF OCULOGYRATION WITH NECK PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION PATTERNS ON TRUNK STABILIZATION AND STANDING BALANCE IN SUBACUTE STROKE
Public title
OCULOGYRATION WITH NECK PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION IN STROKE PATIENTS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with first ever stroke
Patients with subacute stroke
Age between 40-65 years
Both male and female
Patients with unilateral hemiplegia
Patients without any visual disorder
Patients without any hearing disorder
Patients with greater than fair strength of extensor and flexors muscles of neck
Patients with greater than 3 points on functional ambulation classification
Patients with more than twenty-four points on mini mental state examination
Exclusion criteria:
Patients with half blindness and hemineglect
Patients with Oculomotor nerve defect
Patients with cognitive impairment
Patients with any neurological degenerative disease
Patient with any musculoskeletal impairment which affect standing balance
Age
From 40 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Lottery method
Blinding (investigator's opinion)
Single blinded
Blinding description
Participant will be keep blind to the treatment plan.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of The University of Faisalabad
Street address
west canal road, Faisalabad
City
Faisalabad
Postal code
37610
Approval date
2023-03-24, 1402/01/04
Ethics committee reference number
TUF/DR/SA/MSPP/2023/245
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
169.4
ICD-10 code description
Stroke, subacute stroke
Primary outcomes
1
Description
Trunk Stabilization
Timepoint
At baseline, after second week of intervention, after fourth week of intervention, after sixthweek of intervention and after eight week of intervention.
Method of measurement
Trunk Impairment Scale
Secondary outcomes
1
Description
Standing Balance
Timepoint
At baseline, after second week of intervention, after fourth week of intervention, after sixth week of intervention and after eight week of intervention.
Method of measurement
Berg Balance Scale
Intervention groups
1
Description
Intervention group:
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Allied Hospital
Full name of responsible person
Kainat Idrees
Street address
Jail Road adjacent to Faisalabad Medical University, Near Sargodha Road, Faisalabad
City
Faisalabad
Postal code
38800
Phone
+92 41 9210082
Email
vcfmuf@gmail.com
Web page address
https://pmc.edu.pk/S-Result.aspx
2
Recruitment center
Name of recruitment center
District Head Quarter Hospital
Full name of responsible person
Kainat Idrees
Street address
Mall Road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9200140
Email
vcfmuf@gmail.com
Web page address
https://pmc.edu.pk/AboutUs.aspx
3
Recruitment center
Name of recruitment center
Aziz Fatimah Hospital
Full name of responsible person
Kainat Idrees
Street address
Gulistan Colony No: 1 Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 8780910
Email
marketing@afh.com.pk
Web page address
http://www.afh.com.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Kainat Idrees
Street address
house#116 B, Royal Villas, Lower Canal Road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 308 3670766
Email
kainatidrees066@gmail.com
Grant name
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
Kainat Idrees
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
116-B Royal Villas, Lower canal road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38001
Phone
+92 41 8750971
Fax
Email
2021-ms-pt-068@tuf.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Kainat Idrees
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
116-B Royal Villas, Lower canal road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38001
Phone
+92 41 8750971
Fax
Email
2021-ms-pt-068@tuf.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Kainat Idrees
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
116-B Royal Villas, Lower canal road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38001
Phone
+92 41 8750971
Fax
Email
2021-ms-pt-068@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
No further information
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Study protocol
Statistical analysis plan
Informed Consent form
Clinical study report
When the data will become available and for how long
After six months of publication
To whom data/document is available
To all the researchers and institutes
Under which criteria data/document could be used
Data will be shared for further clinical research.
From where data/document is obtainable
Data will be shared through email adresses.
What processes are involved for a request to access data/document