NCT05505851

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable low-back-pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 10, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

May 23, 2022

Last Update Submit

December 8, 2025

Conditions

Keywords

AlignmentCore StabilityDiaphragmPelvic floorDysfunction

Outcome Measures

Primary Outcomes (9)

  • Photometry for Pelvic Tilt

    Angle of Pelvic tilt will be measured Through a Reliable and validated camera.

    Pre (0th week), Post (6th week), (12th week) Follow-up

  • 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.

    Pre (0th week), Post (6th week), (12th week) Follow-up

  • Photometry for Cervicothoracic level

    Angle of C7-T1 will be measured Through a Reliable and validated camera.

    Pre (0th week), Post (6th week), (12th week) Follow-up

  • Photometry for Lumber flexion

    Angle of Lumber curve will be measured Through a Reliable and validated camera.

    Pre (0th week), Post (6th week), (12th week) Follow-up

  • Diaphragmatic excursion

    To assess the diaphragmatic motion by M-mode US a 2.5-5 megahertz (MHz) phase array will be used.

    Pre (0th week), Post (6th week), (12th week) Follow-up

  • Levator ani Excursion

    To assess the pelvic floor motion by M-mode US a 2.5-5 megahertz (MHz) array will be used.

    Pre (0th week), Post (6th week), (12th week) Follow-up

  • Diaphragmatic thickness and thickening

    diaphragmatic thicknesses and thickening will be assessed by B-mode ultrasonography during various respiratory maneuvers

    Pre (0th week), Post (6th week), (12th week) Follow-up

  • Levator ani thickness and thickening

    Levator ani thicknesses and thickening will be assessed by B-mode ultrasonography during various respiratory maneuvers

    Pre (0th week), Post (6th week), (12th week) Follow-up

  • Core stability

    It will be measured by Pressure biofeedback unit for the transverse abdomens.

    Pre (0th week), Post (6th week), (12th week) Follow-up

Secondary Outcomes (3)

  • Forced Vital Capacity (FVC)

    Pre (0th week), Post (6th week), (12th week) Follow-up

  • Forced Expiratory Volume per second FEV1

    Pre (0th week), Post (6th week), (12th week) Follow-up

  • Ratio of FEV1/ FVC

    Pre (0th week), Post (6th week), (12th week) Follow-up

Study Arms (2)

A: Control

ACTIVE COMPARATOR

Corrective Exercises: Hip Flexor Stretch, Thoracolumbar Extensor Stretch, Abdominal Curl, and Glute Bridge.

Other: Control

B: Sequential Core Stability Corrective Exercise Approach

EXPERIMENTAL

Sequential Core Stability Corrective Exercise Approach 1. Corrective Exercises 2. Diaphragm Training Program 3. Pelvic floor Muscle training 4. Core Stability exercises

Other: Sequential Core Stability Corrective Exercise Approach

Interventions

ControlOTHER

Corrective Exercises: Hip Flexor Stretch, Thoracolumbar Extensor Stretch, Abdominal Curl, and Glute Bridge.

A: Control

Sequential Core Stability Corrective Exercise Approach 1. Corrective Exercises 2. Diaphragm Training Program 3. Pelvic floor Muscle training 4. Core Stability exercises 1. Beginning 2. Progressing 3. Advanced

B: Sequential Core Stability Corrective Exercise Approach

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-khumeini Trust Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Kashif, PhD

    Riphah International University

    STUDY CHAIR
  • Wajeeha Zia, PhD*

    Riphah International University , QIE, Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

August 18, 2022

Study Start

February 10, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations