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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05505851
Other study ID # REC/RCR & AHS/22/1104
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 10, 2024
Est. completion date December 1, 2024

Study information

Verified date March 2024
Source Riphah International University
Contact Muhammad Salman Bashir, PhD
Phone +923334497959
Email salman.bashir@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the study will be to determine the effects of Sequential Core Stability Corrective Exercise Approach for Alignment and Muscle Function in Lower Crossed Syndrome.


Description:

Lower Crossed Syndrome is one of common postural disorder which occurs due to the muscular imbalance. It refers to specific altered muscle activation and movement patterns along with some postural deviations. Alterations in muscle activation include overactivity of hip flexors and lower back muscles paired underactivity of abdominals and gluteus muscle. This pattern of imbalance creates dysfunction. Postural correction exercise with inner and outer core muscles are necessary. There are different traditional structural approach, functional approach and biomechanics and are presumed to lead to adjustments in the length and strength of local muscles while ignoring other related malalignments and core stability. The objective of the study will be to determine the effects of Sequential Core Stability Corrective Exercise Approach for Alignment and Muscle Function in Lower Crossed Syndrome. It will be a randomized controlled trial. Sample size will be collected after running the pilot study. The participants will be recruited through convenient sampling technique and then allocated randomly to Groups. Outcome measures will be alignment and muscle function. Pre and post reading and after one month follow-up will be recorded. Data will be analyzed using statistical package for social sciences software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or nonparametric test will be use within a group or between two groups. Keywords: Alignment, Core Stability, Diaphragm, Muscular Imbalance, Muscle thickness Pelvic floor.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 28 Years
Eligibility Inclusion Criteria: - • Age group between 18 to 28 years - No current incidence of low back pain or past history of low back dysfunction - Kendall double leg lowering test: Abdominal muscle weakness to the extent of not being able to maintain posterior pelvic tilt during a double leg lowering test in supine position. - Diagnosed with lower cross syndrome through assessment criteria of Janda muscle testing and assessment Exclusion Criteria: - • Having any history of low back pain, spinal trauma, - Joint dysfunction in past 3 months - Congenital deformities at hip or lumbar region, - Recent fracture to related joints in past 6 months - Any family history of cardiopulmonary disease - Any disease or urogenital tract - Participants having BMI above 30. - Recent history of hepatitis or Fatty liver or - Any athlete having high physical activity. - History of abdominal, hip or lumbar surgeries in past 3 months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Control
Hip Flexor Stretch 30 seconds hold 3 repetitions on each side Thoracolumbar extensors stretch 30 second holds 3 repetitions Abdominal Curl ups with hands at side 10 repetitions 2 sets Progression: • Abdominal curl up with arms crossed • Abdominal curl ups with hands behind head Pelvic bridging 10 seconds hold 10 repetitions 2 sets
Sequential Core Stability Corrective Exercise Approach
Corrective Exercises Diaphragm Training Program As per standardized pulmonary rehabilitation guidelines,. Participant will be advised to breathe in gently with an improved tidal volume for ten repetitions, then after a short interval of break 15 repetitions will be done again. 30 Repetitions in set of 15, 15 with the interval rest. 2 sets. Pelvic floor Muscle training Participants will be asked to do pelvic floor training with high intensity (close to maximum) contractions with holding each muscle contraction for 6-8 seconds with relaxation of 6 seconds. Total 8 to 12 contractions. Core Stability exercises Beginning Progressing Advanced

Locations

Country Name City State
Pakistan Al-khumeini Trust Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Photometry for Pelvic Tilt Angle of Pelvic tilt will be measured Through a Reliable and validated camera. 6th Week
Primary Photometry for Chest Expansion Angle of Chest expansion will be measured at Nipple line, Xiphoid level and at waist level, Through a Reliable and validated camera. 6th Week
Primary Photometry for Cervicothoracic level Angle of C7-T1 will be measured Through a Reliable and validated camera. 6th Week
Primary Photometry for Lumber flexion Angle of Lumber curve will be measured Through a Reliable and validated camera. 6th Week
Primary Diaphragmatic excursion To assess the diaphragmatic motion by M-mode US a 2.5-5 megahertz (MHz) phase array will be used. 6th Week
Primary Levator ani Excursion To assess the pelvic floor motion by M-mode US a 2.5-5 megahertz (MHz) array will be used. 6th Week
Primary Diaphragmatic thickness and thickening diaphragmatic thicknesses and thickening will be assessed by B-mode ultrasonography during various respiratory maneuvers 6th Week
Primary Levator ani thickness and thickening Levator ani thicknesses and thickening will be assessed by B-mode ultrasonography during various respiratory maneuvers 6th Week
Primary Core stability It will be measured by Pressure biofeedback unit for the transverse abdomens. 6th Week
Secondary Forced Vital Capacity (FVC) Pulmonary function test through spirometer, It will be measured by digital spirometer. 6th Week
Secondary Forced Expiratory Volume per second FEV1 Pulmonary function test through spirometer, It will be measured by digital spirometer. 6th Week
Secondary Ratio of FEV1/ FVC Pulmonary function test through spirometer, It will be measured by digital spirometer. 6th Week
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