NCT06198036

Brief Summary

The most important aspect of physical fitness is flexibility, which can be greatly impacted by bad posture. Long periods of sitting in school going children can cause the hamstring muscles to shorten because they bend the knee. There are numerous methods for improving hamstring flexibility, but very few of them produce immediate results. The purpose of this study will be to compare between the immediate effects of hold-relax proprioceptive neuromuscular facilitation and muscle energy technique (MET) for hamstring flexibility in school going children. This will be the randomized clinical trial in which total time of six month will be utilized after the approval from BASR. Data will be collected from Unique Science School Al-Rehman Campus, Lahore. 106 participants will be taken with 05-12 years of age through purposive sampling technique. Participants will be divided into two equal groups. Participants in group A will be given hold-relax PNF and the group B will underwent METs (reciprocal inhibition). Hamstring ROM will be assessed through AKET. Measurements will be taken by goniometer. Wong-Baker faces pain scale (WBFPS) and Timed 'Up and Go' (TUG) test will be used to evaluate pain and functional mobility respectively. Data will be analyzed on SPSS version 25. Results after statistical analysis will show which technique is more effective and will have best outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

December 26, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

METsHamstring flexibilitySchool going children

Outcome Measures

Primary Outcomes (2)

  • Goniometer

    The universal full circle goniometer is arguably the preferred instrument for measuring ROM for the majority of applications to the extremities. This version, which has a body, moving arm, and stationary arm, is the most prevalent. When comparing radiographic measurements with goniometric measurements in sedated and unsedated cats, joint measurements did not change significantly by measurement type. Cronbach alpha values for goniometric joint measurements were more than 0.99.

    eight weeks

  • Active Knee Extension Test (AKET)

    The Active Knee Extension Test measures the range of active knee extension when the hip is flexed as well as the length of the hamstring muscles. If the body positions are sufficiently stable, this test has a high degree of reliability. This test, a self-monitored variation of the active knee extension test, has also proven to be successful when performed by the person being tested. Among healthy individuals, the inter-rater and intra rater dependability has been proven.

    eight weeks

Secondary Outcomes (2)

  • Wong Baker Faces Pain Scale (WBFPS)

    Eight weeks

  • Timed 'Up and Go' Test (TUG)

    Eight Weeks

Study Arms (2)

Group A: Application of Hold-Relax PNF Technique

ACTIVE COMPARATOR

A hold-relax technique that entails stretching the muscle to its maximum length. Participant will be in supine position. The hamstring muscle will be stretched for 7 to 10 seconds while the individual reported only a slight stretch in the muscle. The participant then attempts to lower his leg towards the table while being resisted by the researcher, isometrically contracting his hamstring muscle for 3 seconds. The patient then instructed to relax for five seconds. The researcher then passively stretched the muscle until a slight sensation of stretch was experienced. The stretch will maintain for seven seconds. There were five repetitions of this sequence, each one 20 seconds apart from the previous one

Other: Hold-Relax Technique

Group B: Application of Muscle Energy Technique

ACTIVE COMPARATOR

Group B will receive a Muscle Energy Technique (MET) applying the reciprocal inhibition principle. Participant will be in supine lying and the affected muscle held in a mid-range position. The Reciprocal Inhibition-MET group stretched for 10 to 60 seconds after performing an isometric contraction of the muscle opposite the one that needed to be stretched for 7 to 10 seconds (30%-50% of the time) followed by 5 second rest interval. With a pause of 20 seconds in between each repetition, this sequence was performed five times(52). The readings for Active knee Extension (AKE), TUG test and WBFPS before and after treatment session determined the improvement regarding the treatment outcomes.

Other: Muscle Energy Technique

Interventions

Participants in this group will be treated with hold-relax PNF Technique

Group A: Application of Hold-Relax PNF Technique

Participants in this group will be treated with Muscle Energy Technique via Reciprocal Inhibition Mechanism

Group B: Application of Muscle Energy Technique

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 5-12 years children
  • Gender (both male and female)
  • Normal children
  • Hamstring tightness (minimum degree \<160 degrees

You may not qualify if:

  • Regular athletes
  • Past pathology
  • Post fracture of limb
  • Leg length discrepancy
  • History of spinal cord injury
  • Presence of physical deformities
  • Subject not willing to participate
  • Subject using lower limb prosthesis or orthotic device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, Pakistan

Location

Related Publications (1)

  • Funk D, Swank AM, Adams KJ, Treolo D. Efficacy of moist heat pack application over static stretching on hamstring flexibility. J Strength Cond Res. 2001 Feb;15(1):123-6.

    PMID: 11708695BACKGROUND

Study Officials

  • Sunnia Mudabber, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants will get separate treatment protocols and possible efforts will be put to mask the both groups about their treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will be Randomized Clinical Trial to compare between the immediate effects of hold-relax Proprioceptive Neuromuscular Facilitation and Muscle Energy Technique (RI) for hamstring flexibility in school. Participants meeting the pre-determind inclusion and exclusion criteria will be divided into two groups going children
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 10, 2024

Study Start

December 1, 2023

Primary Completion

February 5, 2024

Study Completion

February 5, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations