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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04967924
Other study ID # REC/Lhr/21/0414 Maliah
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 9, 2021
Est. completion date August 10, 2021

Study information

Verified date August 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized Clinical Trial in rugby sports club in Lahore. A Sample size of 26 is calculated using epitol.Group A: Sports specific training Treatments will be provided in 30 mins per week for 3 consecutive weeks. Weight programs include closed chain exercises (squats, pushups) and open chain exercises (leg press, chest fly using dumbbell) Stretch shortening cycle (enhances performance through storage of elastic energy during eccentric phase and activation of stretch reflex). Group B: neuromuscular training Treatments will be provided in 30 mins per week for 3 consecutive weeks Proprioceptive Neuromuscular Facilitation (PNF)


Description:

Rugby require constant pace changes that generates high musculoskeletal demand in rugby one of the commonly affected area is low back pain that can affect player performance and can be accelerated by injury, health and lifestyle factors and possibly by joint pain or musculoskeletal disorders. Data will be collected from players in registered rugby clubs of district Lahore. Informed consents will be taken from all participants with the knowledge of aims and procedure. The results of this study will help to improve treatment protocols options for players how it affects the rehab process and how it affects the movement and pain how it affects the rehab process and how the pain restricts movements among rugby players. This study will be based on a randomized clinical trial used to study the different level of effectiveness of sports specific training versus neuromuscular training on dynamic balance mobility, flexibility in field rugby players. Subjects with low back pain meeting the predetermined inclusion & exclusion criteria will be divided into two groups by randomization to avoid any plagiarism. Dynamic Balance, measured with Star Excursion Balance Test; Active Range of Motion (ROM), using a manual goniometer and Lumbar Flexibility, assessed with Fingertip-to-floor test will be used for data collection. Subjects in one group will be treated with Bilateral stretches, contract-relax PNF stretching training and other will be treated with weight training, aerobic exercises. Each subject will receive a total four weeks treatment session, thirty minutes sessions will be performed once a week for three weeks. Three evaluations will be performed once before treatment One week after treatment and four week post treatment follow-ups. Sample size 26 each group contains 13 participants. All statistical analysis will be performed with spss16.0.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date August 10, 2021
Est. primary completion date August 9, 2021
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 30 Years
Eligibility Inclusion Criteria: - Female rugby players - Who had suffered minor musculoskeletal injuries that did not preclude their sports participation. - Age ranges from 16-30 - Being able to cooperate Exclusion Criteria: - Players presenting injuries which implied radicular compromise (sciatic pain, etc.) - Players who had suffered moderate or severe musculoskeletal injuries in the past 6 months which precluded their normal sports participation. - Traumatic pain, fractures or ruptured ligaments. - Inflammatory and Infectious conditions - Any recent surgical intervention - Tumors/malignancy of bone

Study Design


Related Conditions & MeSH terms


Intervention

Other:
neuromuscular training
Treatments will be provided in 30 mins per week for 3 consecutive weeks Proprioceptive Neuromuscular Facilitation (PNF)
Sports specific training
Treatments will be provided in 30 mins per week for 3 consecutive weeks. Weight programs include closed chain exercises (squats, pushups) and open chain exercises (leg press, chest fly using dumbbell) Stretch shortening cycle (enhances performance through storage of elastic energy during eccentric phase and activation of stretch reflex).

Locations

Country Name City State
Pakistan Pakistan Sports Board Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Amado-Bonilla E, Pintado-Vidal MI, Mangas-Borrego MI, Marchena-Ortiz E, Barrantes-Chacon J, Moran JM. Comment on "Reference Values of Total Lean Mass, Appendicular Lean Mass, and Fat Mass Measured with Dual-Energy X-ray Absorptiometry in a Healthy Mexican Population".https://www.ncbi.nlm.nih.gov/pubmed/27815567/. Calcif Tissue Int. 2017 Jun;100(6):653. doi: 10.1007/s00223-016-0204-9. Epub 2016 Nov 4. — View Citation

Espí-López GV, López-Martínez S, Inglés M, Serra-Añó P, Aguilar-Rodríguez M. Effect of manual therapy versus proprioceptive neuromuscular facilitation in dynamic balance, mobility and flexibility in field hockey players. A randomized controlled trial. Phys Ther Sport. 2018 Jul;32:173-179. doi: 10.1016/j.ptsp.2018.04.017. Epub 2018 Apr 22. — View Citation

Filipa AR, Smith TR, Paterno MV, Ford KR, Hewett TE. Performance on the Star Excursion Balance Test predicts functional turnout angle in pre-pubescent female dancers. J Dance Med Sci. 2013 Dec;17(4):165-9. — View Citation

Wang L, Xiao Y, Tian T, Jin L, Lei Y, Finnell RH, Ren A. Corrigendum to "Digenic variants of planar cell polarity genes in human neural tube defect patients." Mol Genet Metab. 2018 May;124(1):94-100. doi:10.1016/j.ymgme.2018.03.005. Epub 2018 Mar 18. https://pubmed.ncbi.nlm.nih.gov/29573971/. Mol Genet Metab. 2021 Mar;132(3):211. doi: 10.1016/j.ymgme.2021.01.010. Epub 2021 Feb 10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Goniometer To measure ROM at hip and knee joints 6 weeks
Primary Star exclusion test The test originally incorporated reaching in eight directions while standing on each foot. the 8 different directions are following: anterior, anteromedial, medial, posteromedial, posterior, posterolateral, lateral and anterolateral.
SEBT performance scores using the following simple equations:
Average distance in each direction (cm) = Reach 1 + Reach 2 + Reach 3 / 3
Relative (normalised) distance in each direction (%) = Average distance in each direction / leg length * 100
6 weeks
Primary Finger tip to floor test The patient is asked to bend forward and attempt to reach for the floor with their fingertips. The physical therapist then measures the distance between the patient's right long finger and the floor using a standard measuring tape.
Mean fingertip- to-floor test was 21.5 21.7cm (range, 0-48cm) for men and 19.6 22cm (range, 0-50cm) for women
6 weeks
Secondary visual analogue scale for pain Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." 6 weeks
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