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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06131658
Other study ID # REC/RCR&AHS/23/0429
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 20, 2023
Est. completion date August 20, 2024

Study information

Verified date June 2024
Source Riphah International University
Contact Amna Shahid, MS-DPT
Phone +92 334 4512823
Email amna.shahid@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A & B through sealed envelope method by non-probability convenient random sampling technique. Subjects in group A will receive functional motor control exercises. Group B will receive conventional exercises.


Description:

The objective of this study is to determine the effects of functional motor control exercises on pain, flexibility and lower limb functional. It will be randomized controlled trial (RCT) research design at Pakistan sports board through non probability convenience sampling technique on 72 runners' athletes which will be allocated using random sampling through computerized generated number into Group A and Group B, 36 athletes will be in each group. Group A (interventional) will be given conventional training with functional motor exercise and Group B (control) will be given conventional training. There will be 3 sessions in a week for 6 weeks. The baseline scoring will be on 1st day, follow up will be taken at 6th week. Assessment will be made by Numeric pain rating scale, Lower extremity functional scale (LEFS), Single leg mini squat, Y balance. Data will be analyzed during SPSS software version 26. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two group


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date August 20, 2024
Est. primary completion date June 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 40 Years
Eligibility Inclusion Criteria: - male and female athlete within 19-40 years, - running a minimum average of 15 running kilometers, - Runners with one sided iliotibial band syndrome for at least 3 months were included, - Pain along IT band at either Gerdy's tubercle or the lateral femoral epicondyle during running, - positive stiffness with Ober's test, and - reporting pain during Noble's compression test. Exclusion Criteria: - Individuals with a history of previous knee trauma of past 6 months, - Individuals with a history of previous knee surgery of past 6 months, - Other knee abnormalities including patellofemoral joint pain, - popliteus tendinitis, - lateral meniscal injury, - Degenerative joint disease, and - lateral collateral ligament sprain to the affected side.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Functional motor control excercise
This include functional motor control thrice a week for six weeks
convectional excercise
This include convectional exercise thrice a week for six weeks

Locations

Country Name City State
Pakistan Jawad Club Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

Baker RL, Fredericson M. Iliotibial Band Syndrome in Runners: Biomechanical Implications and Exercise Interventions. Phys Med Rehabil Clin N Am. 2016 Feb;27(1):53-77. doi: 10.1016/j.pmr.2015.08.001. — View Citation

Fredericson M, Cookingham CL, Chaudhari AM, Dowdell BC, Oestreicher N, Sahrmann SA. Hip abductor weakness in distance runners with iliotibial band syndrome. Clin J Sport Med. 2000 Jul;10(3):169-75. doi: 10.1097/00042752-200007000-00004. — View Citation

McKean KA, Manson NA, Stanish WD. Musculoskeletal injury in the masters runners. Clin J Sport Med. 2006 Mar;16(2):149-54. doi: 10.1097/00042752-200603000-00011. — View Citation

Noehren B, Davis I, Hamill J. ASB clinical biomechanics award winner 2006 prospective study of the biomechanical factors associated with iliotibial band syndrome. Clin Biomech (Bristol, Avon). 2007 Nov;22(9):951-6. doi: 10.1016/j.clinbiomech.2007.07.001. Epub 2007 Aug 28. — View Citation

Taunton JE, Ryan MB, Clement DB, McKenzie DC, Lloyd-Smith DR, Zumbo BD. A retrospective case-control analysis of 2002 running injuries. Br J Sports Med. 2002 Apr;36(2):95-101. doi: 10.1136/bjsm.36.2.95. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric pain rating scale pain will be assess by Numeric pain rating scale with minimum score 0 to maximum score 10 pre and 6 weeks post interventional
Primary flexibility flexibility will be assess by Y balance pre and 6 weeks post interventional
Primary lower extremity function lower extremity function will be assess by lower limb extremity scale with score 0 to 80 pre and 6 weeks post interventional
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