Protocol summary

Study aim
The purpose of this study was to compare the effect of rhythmic initiation and slow reversal pelvic PNF technique to improve static and dynamic balance in stroke hemiplegic patients.
Design
Randomised controlled trials
Settings and conduct
Allied Hospital Faisalabad District Head Quarter Hospital Faisalabad
Participants/Inclusion and exclusion criteria
inclusion criteria: 30 participants with hemiplegic stroke, both male and female with 45-60 years of age,With first unilateral stroke within 6 months, were able to walk with walking aids or assistance for 10 meters,No PNF treatment was given to the pelvic area since 6 weeks, Patients on BBS scoring less than or equal to 30 with minimum score 20. Exclusion Criteria: Those participants who had pelvic dysfunction other than stroke, pelvic fracture within last 6 months, having spinal deformity, with cognitive dysfunction, lower limb MSK disorders, Having severe disabling arthritis and patients having cardiopulmonary deficits, having severe degenerative changes and having Benign Paroxysmal Positional Vertigo
Intervention groups
Intervention group (Group A) Rhythmic Initiation Intervention group (Group B) Slow Reversals
Main outcome variables
Static Balance Dynamic Balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210823052272N1
Registration date: 2021-09-16, 1400/06/25
Registration timing: retrospective

Last update: 2021-09-16, 1400/06/25
Update count: 0
Registration date
2021-09-16, 1400/06/25
Registrant information
Name
Aamna Masood
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8860190
Email address
dpt-fa14-089@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-31, 1400/03/10
Expected recruitment end date
2021-08-10, 1400/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Rhythmic Initiation and Slow Reversal PNF Technique on Pelvis to improve Static and Dynamic Balance in Stroke Hemiplegic Patients
Public title
Comparison of Pelvic PNF techniques to improve balance in stroke patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Both Male and Female participants of age 45-60 years. With first unilateral stroke within 6 months. The participants who will able to walk with walking aids or assistance for 10meters. No PNF treatment given to the pelvic area since 6 weeks Patients on Berg Balance Scale scoring less than or equal to 30 with minimumscore 20
Exclusion criteria:
Those participants having pelvic dysfunction other than stroke. Having pelvic fracture within last 6 months Patients having spinal deformity. Patients with cognitive dysfunction. Patients having lower limb MSK disorders. Having severe disabling arthritis and patients having cardiopulmonary deficits Patients having severe degenerative changes. Patients having Benign Paroxysmal Positional Vertigo (BPPV).
Age
From 45 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Thirty (n=30) participants were selected for the study. These were randomized through purposive sampling technique which is a type of non-probability sampling technique, into two groups: group A (Rhythmic initiation, n=15) and group B (Slow reversal, n=15). The participants were then randomly allocated to both groups by lottery method.
Blinding (investigator's opinion)
Single blinded
Blinding description
participants were not told which group they have been allocated, neither they know the treatment of other group participants.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The etihical committee of The University of Faisalabad
Street address
Sargodha road, Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2021-05-25, 1400/03/04
Ethics committee reference number
TUF/DR/MSPP/307

Health conditions studied

1

Description of health condition studied
inability to maintain stability in stroke patients with one sided body weakness.
ICD-10 code
I63
ICD-10 code description
Cerebral infarction

Primary outcomes

1

Description
Static and Dynamic Balance
Timepoint
before intervention and after the last treatment session
Method of measurement
Berg Balance Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Rhythmic Initiation PNF technique
Category
Rehabilitation

2

Description
Intervention group: Slow Reversals PNF technique
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Allied Hospital Faisalabad
Full name of responsible person
Sobia Nawaz
Street address
Dr Tusi Road, Faisalabad, Punjab
City
Faisalabad
Postal code
041
Phone
+92 41 9210082
Email
info@pmc.edu.pk

2

Recruitment center
Name of recruitment center
District Head Quarter Hopsital
Full name of responsible person
Shaista Bano
Street address
Mall Road, Faisalabad, Punjab
City
Faisalabad
Postal code
041
Phone
+92 41 9200140
Email
vcfmuf@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Sidra Majeed
Street address
Sargodha Rd, University Town, Faisalabad, Punjab 38000
City
Faisalabad
Postal code
041
Phone
+92 41 8868326
Email
studentaffairshsw@tuf.edu.pk
Web page address
https://tuf.edu.pk/contact
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Aamna Masood
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
666- K Gulistan Colony no 1
City
Faisalabad
Province
Punjab
Postal code
041
Phone
+92 41 8860190
Email
aamnamasood27@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Aamna Masood
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
666- K Gulistan Colony no 1 FSD
City
Faisalabad
Province
Punjab
Postal code
041
Phone
+92 41 8860190
Email
aamnamasood27@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Aamna Masood
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
666- Gulistan Colony no 1 FSD
City
Faisalabad
Province
Punjab
Postal code
041
Phone
+92 41 8860190
Email
aamnamasood27@gmail.com

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
a consent form was signed from patients, that their data will be safe including identity and contact information and not shared to anyone.
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
the data regarding outcome measures will be shared, but the identity of patient will be kept hidden because a consent was signed from them
When the data will become available and for how long
2022
To whom data/document is available
everyone related to this field.
Under which criteria data/document could be used
whoever will request for data
From where data/document is obtainable
document is obtainable through email address
What processes are involved for a request to access data/document
to access data one should approach through the email provided.
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