Protocol summary

Study aim
To determine the comparative effect of post isometric relaxation and static stretching on stride length in students with hamstrings tightness.
Design
A single blinded quantitative study following the randomized clinical trial with blinded post-treatment outcome and assessment and randomization will be done by lottery method.
Settings and conduct
The population for this study will be undergraduate students of Government college University Faisalabad, Pakistan. Participants will be blinded they will not be aware which treatment technique will they have. Data will be collected pre and post treatment.
Participants/Inclusion and exclusion criteria
Inclusion Criteria •University students •Age from 18-27 years •Sitting duration more than 6 hours •Subjects with at least 15° loss of knee extension on Active knee extension test •SLR less than 60° •Bilateral Hamstrings tightness Exclusion Criteria • Any recent trauma history (within last 3 months) •Neuromuscular disorders of the lower extremity • Acute spasm of hamstring muscles •Spinal deformity or injury •Leg length discrepancy • Recent hamstring strain •Foot deformity/ disorder
Intervention groups
For static stretching group (Group A) treatment protocol will be passive static stretch with 30 se hold and repeat for 3 in each session. 3 sessions in a week will give to subjects on alternate days and for 3 weeks. For PIR group (Group B) therapist will ask subject to perform isometric contraction with 20% force and hold it for 10 sec after that subject will relax and therapist will apply passive stretch and hold for 30 sec. the same process will be repeated 3 times in each session. 3 sessions in a week will be given to subjects on alternate days and for 3 weeks
Main outcome variables
Stride length and hamstrings flexibility

General information

Reason for update
Acronym
PIR (Post Isometric relaxation), SS (Static Stretching)
IRCT registration information
IRCT registration number: IRCT20230628058605N1
Registration date: 2024-05-20, 1403/02/31
Registration timing: retrospective

Last update: 2024-05-20, 1403/02/31
Update count: 0
Registration date
2024-05-20, 1403/02/31
Registrant information
Name
Alina Mann
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 324 7106668
Email address
anniemann64@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-17, 1402/05/26
Expected recruitment end date
2023-09-18, 1402/06/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effect Of Post Isometric Relaxation and Static Stretching on Stride Length And Flexibility In Patients With Hamstrings Tightness; A Randomized Clinical Trial
Public title
Effect of Post Isometric Relaxation and Static Stretching on Stride Length and Flexibility in Patients with Hamstrings Tightness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The University students who have age from 18 to 27 years. Sitting duration more than 6 hours Subjects with at least 15° loss of knee extension on Active knee extension test and SLR less than 60° Subjects having Bilateral Hamstrings tightness
Exclusion criteria:
Any recent trauma history (within last 3 months) Neuromuscular disorders of the lower extremity Acute spasm of hamstring muscles Spinal deformity or injury Leg length discrepancy Recent hamstring strain Foot deformity/ disorder
Age
From 18 years old to 27 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Sample is allocated in two groups by simple randomization. Randomization is done by lottery method. Randomly a number is picked and allocated to group A and Group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants of both group will be unaware of the treatment. Participants of both groups will receive the same baseline treatment that is 10 minutes walking. After that Physiotherapist will apply two techniques PIR and SS to both groups and subjects will unaware of that which one will they have.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of The University of Faisalabad
Street address
4-Km, Sargodha road, university town, Faisalabad Pakistan
City
Faisalabad
Postal code
38000
Approval date
2023-08-16, 1402/05/25
Ethics committee reference number
TUF/DR/MSPP/322

Health conditions studied

1

Description of health condition studied
Hamstring tightness which represents itself as limited motion at the hip and knee due to the diminished capacity of the muscle to stretch and permit adequate joint movement needed to perform the important activities is common issue. Hamstring tightness is considered to be the result of decrease ability of muscle to elongate which can be due to myofascial adhesions and neural or mechanical problems. This restricted the ability of muscle to glide freely and limit the full joint motion.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Stride Length
Timepoint
Before treatment, after 3 weeks of treatment and after 1 month follow up
Method of measurement
Peadometer

Secondary outcomes

1

Description
Hamstrings Flexibility
Timepoint
Before intervention after 3 weeks of intervention and after 1 month follow up
Method of measurement
By active knee extension test and straight leg raise test

Intervention groups

1

Description
Intervention group1: Static stretching (Group A): For static stretching group treatment protocol will be passive static stretch with 30 se hold and repeat for 3 in each session. 3 sessions in a week will give to subjects on alternate days and for 3 weeks.
Category
Rehabilitation

2

Description
Intervention group 2: Post isometric relaxation (Group B): For PIR group passively flex the hip until restriction will be found at this point therapist will ask subject to perform isometric contraction with 20% force and hold it for 10 sec after that subject will relax and therapist will apply passive stretch and hold for 30 sec. the same process will be repeated 3 times in each session. 3 sessions in a week will be given to subjects on alternate days and for 3 weeks
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Government college university of Faisalabad , Pakistan
Full name of responsible person
Prcipal of University
Street address
Kotwali Rd, Gurunanakpura, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 9200886
Email
info@gcuf.edu.pk
Web page address
https://gcuf.edu.pk/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr Sidra Majeed
Street address
4-Km Sargodha road university town, Faisalabad, Pakistan
City
Faislabad
Postal code
38000
Phone
+92 41 87509715
Fax
+92 41 8750970
Email
info@tuf.edu.pk
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Dr. Sidra Majeed; PT
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
4-Km Sargodha road, University town Faisalabad, Pakistan
City
Faisalabd
Province
Punjab
Postal code
38000
Phone
+92 41 8868326
Email
info@tuf.edu.pk
Web page address
https://www.tuf.edu.pk/

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Alina Tariq Mann
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no. P-87, Stree no 2 Gurunanak Pura, Faisalabad, Pakistan
City
Faisalabd
Province
Punjab
Postal code
38000
Phone
+92 41 2611919
Email
anniemann64@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Alina Tariq Mann
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house no P-87, Street no 2, Grunanak pura, Faisalabad, Pakistan
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
0099241-2611919
Email
anniemann64@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
Undecided - It is not yet known if there will be 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
All collected deidentified participant data set for the outcome measure.
When the data will become available and for how long
4 months after publication
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
IPD and any additional supporting documents will be provided
From where data/document is obtainable
Contact person: Alina Mann Contact: 923247106668 Email: anniemann64@gmail.com
What processes are involved for a request to access data/document
Data files will be provided
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