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Comparative Effects of Clamshells and Frog Pump Exercises

Primary Purpose

Iliotibial Band Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Clamshell Exercise
Frog pump exercise
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Iliotibial Band Syndrome focused on measuring gluteus medius, pain, iliotibial band syndrome, strength

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: • Age (18-30yrs) Gender (Males) Positive Ober's test Positive Noble's compression test Suffering pain from past 3 months Running approximately 5km/week Exclusion Criteria: • Osteoporosis Previous knee trauma/surgery Patellofemoral joint pain Popliteus tendinitis Lateral meniscal injure

Sites / Locations

  • Pakistan Sports BoardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A: Clamshell Exercise

Group B: Frog Pump Exercise

Arm Description

Group B will be given frog pumps exercises in their regular training program. These exercises are given as: In (0-2) week ,2 sets 10 repetitions In (2-4)week, 3 sets of 10 repetitions In (4-6)week, 3 sets of 15 repetitions

Group B will be given frog pumps exercises in their regular training program. These exercises are given as: In (0-2) week ,2 sets 10 repetitions In (2-4)week, 3 sets of 10 repetitions In (4-6)week, 3 sets of 15 repetitions

Outcomes

Primary Outcome Measures

Manual Muscle Testing (MMT)
For measuring the strength of Hip muscles, Manual Muscle Testing (MMT) is used. Manual Muscle Testing (MMT) is a standardised set of assessments that measure muscle strength and function against specific criteria and is commonly used in clinical practice by physiotherapists. Grading Scale Range: 0 to 5 0 None No visible or palpable contraction Trace Visible or palpable contraction with no motion Poor Full ROM gravity eliminated Fair Full ROM against gravity Good Full ROM against gravity, moderate resistance Normal Full ROM against gravity, maximum resistance
Hip Outcome Score (HOS)
The hip outcome score (HOS) is a questionnaire used to measure the function of the Hip. The HOS is a patient-completed measure that consists of an "Activities of Daily Living" subscale (17 scored items) and a "Sports" subscale (9 scored items) in which the response options are presented as 5-point Likert scales (Scores 0-4).
Lower Extremity Functional Scale (LEFS)
The lower extremity functional scale (LEFS) measures the function and disability of the lower extremity. LEFS is a well-known and validated instrument for the measurement of lower extremity function. The LEFS was developed in a group of patients with various musculoskeletal disorders. The LEFS rating scale categories are: (1) "extreme difficulty or unable to perform," (2) "quite a bit of difficulty," (3) "moderate difficulty," (4) "a little bit of difficulty," and (5) "no difficulty." LEFS score = SUM (points for all 20 activities) Interpretation: Minimum score: 0 Maximum score: 80 The lower the score the greater the disability.

Secondary Outcome Measures

Full Information

First Posted
June 27, 2023
Last Updated
July 25, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05973708
Brief Title
Comparative Effects of Clamshells and Frog Pump Exercises
Official Title
Comparative Effects of Clamshells and Frog Pump Exercises on Gluteus Medius Strengthening and Lower Extremity Function in Runners With Iliotibial Band Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Iliotibial band syndrome is where a tendon called iliotibial band gets irritated or swollen from rubbing against hip or knee when it gets too tensed. Iliotibial band (ITB) syndrome (ITBS) is the most common cause of lateral knee pain among athletes who are involved in sports that require continuous running or repetitive knee flexion and extension. The incidence ranges from 1.6% to 12% in runners. The aim of the study is to compare the effects of clamshells and frog pump exercises on gluteus medius strengthening and lower extremity function in runners with iliotibial band syndrome.
Detailed Description
This study will be a randomized clinical trial and will be conducted in Pakistan Sports Board Lahore. Non-probability convenient sampling will be used to collect the data. Sample size of 32 subjects with age group between 18-30 years (males) will be taken. Data will be collected from the runners with tight ITB, by using tools LEFS, HOS-SS, and Hand held dynamometer. An informed consent will be taken. A total of 26 subjects will be selected by following inclusion and exclusion criteria and will equally divided in to two groups by random number generator table. Both the Groups will continue the conventional training with Group A will receive clamshell Exercise, and Group B will receive frog pump exercise in their respective training programs. Outcome measures will be measured at baseline and after 2 weeks. Data analysis will be done by SPSS version 25.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iliotibial Band Syndrome
Keywords
gluteus medius, pain, iliotibial band syndrome, strength

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Clamshell Exercise
Arm Type
Active Comparator
Arm Description
Group B will be given frog pumps exercises in their regular training program. These exercises are given as: In (0-2) week ,2 sets 10 repetitions In (2-4)week, 3 sets of 10 repetitions In (4-6)week, 3 sets of 15 repetitions
Arm Title
Group B: Frog Pump Exercise
Arm Type
Active Comparator
Arm Description
Group B will be given frog pumps exercises in their regular training program. These exercises are given as: In (0-2) week ,2 sets 10 repetitions In (2-4)week, 3 sets of 10 repetitions In (4-6)week, 3 sets of 15 repetitions
Intervention Type
Other
Intervention Name(s)
Clamshell Exercise
Intervention Description
Clamshell Exercise: The clamshell exercise keeps the hips moving, it strengthens both the gluteus medius AND gluteus maximus. The gluteus medius is the main abductor (movement away from the midline of the body) and external rotator of the hip.
Intervention Type
Other
Intervention Name(s)
Frog pump exercise
Intervention Description
Frog pump exercise: The frog hip thrust mainly targets the gluteal muscles responsible for thigh extension and abduction. The exercise also works the hamstrings on the back of the thighs which helps in hip extension.
Primary Outcome Measure Information:
Title
Manual Muscle Testing (MMT)
Description
For measuring the strength of Hip muscles, Manual Muscle Testing (MMT) is used. Manual Muscle Testing (MMT) is a standardised set of assessments that measure muscle strength and function against specific criteria and is commonly used in clinical practice by physiotherapists. Grading Scale Range: 0 to 5 0 None No visible or palpable contraction Trace Visible or palpable contraction with no motion Poor Full ROM gravity eliminated Fair Full ROM against gravity Good Full ROM against gravity, moderate resistance Normal Full ROM against gravity, maximum resistance
Time Frame
upto 6th weeks
Title
Hip Outcome Score (HOS)
Description
The hip outcome score (HOS) is a questionnaire used to measure the function of the Hip. The HOS is a patient-completed measure that consists of an "Activities of Daily Living" subscale (17 scored items) and a "Sports" subscale (9 scored items) in which the response options are presented as 5-point Likert scales (Scores 0-4).
Time Frame
upto 6th weeks
Title
Lower Extremity Functional Scale (LEFS)
Description
The lower extremity functional scale (LEFS) measures the function and disability of the lower extremity. LEFS is a well-known and validated instrument for the measurement of lower extremity function. The LEFS was developed in a group of patients with various musculoskeletal disorders. The LEFS rating scale categories are: (1) "extreme difficulty or unable to perform," (2) "quite a bit of difficulty," (3) "moderate difficulty," (4) "a little bit of difficulty," and (5) "no difficulty." LEFS score = SUM (points for all 20 activities) Interpretation: Minimum score: 0 Maximum score: 80 The lower the score the greater the disability.
Time Frame
upto 6th weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Age (18-30yrs) Gender (Males) Positive Ober's test Positive Noble's compression test Suffering pain from past 3 months Running approximately 5km/week Exclusion Criteria: • Osteoporosis Previous knee trauma/surgery Patellofemoral joint pain Popliteus tendinitis Lateral meniscal injure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samrood Akram, MPhil
Phone
923324806143
Email
samrood.akram@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Samrood Akram, Mphil
Phone
923324806143
Email
samrood.akram@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samrood Akram, Mphil
Organizational Affiliation
Riphah International University,Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Sports Board
City
Lahore
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samrood Akram, Mphil
Phone
923324806143
Email
samrood.akram@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35007886
Citation
Friede MC, Innerhofer G, Fink C, Alegre LM, Csapo R. Conservative treatment of iliotibial band syndrome in runners: Are we targeting the right goals? Phys Ther Sport. 2022 Mar;54:44-52. doi: 10.1016/j.ptsp.2021.12.006. Epub 2021 Dec 27.
Results Reference
background
PubMed Identifier
21665168
Citation
Baker RL, Souza RB, Fredericson M. Iliotibial band syndrome: soft tissue and biomechanical factors in evaluation and treatment. PM R. 2011 Jun;3(6):550-61. doi: 10.1016/j.pmrj.2011.01.002.
Results Reference
background
PubMed Identifier
15864895
Citation
Khaund R, Flynn SH. Iliotibial band syndrome: a common source of knee pain. Am Fam Physician. 2005 Apr 15;71(8):1545-50.
Results Reference
background
PubMed Identifier
20086621
Citation
Fredericson M, Guillet M, Debenedictis L. Innovative solutions for iliotibial band syndrome. Phys Sportsmed. 2000 Feb;28(2):53-68. doi: 10.3810/psm.2000.02.693.
Results Reference
background
PubMed Identifier
32448384
Citation
McKay J, Maffulli N, Aicale R, Taunton J. Iliotibial band syndrome rehabilitation in female runners: a pilot randomized study. J Orthop Surg Res. 2020 May 24;15(1):188. doi: 10.1186/s13018-020-01713-7.
Results Reference
background
PubMed Identifier
15896092
Citation
Fredericson M, Wolf C. Iliotibial band syndrome in runners: innovations in treatment. Sports Med. 2005;35(5):451-9. doi: 10.2165/00007256-200535050-00006.
Results Reference
background

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Comparative Effects of Clamshells and Frog Pump Exercises

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