Development and Validation of MPF to Prevent and Mitigate Postural Hyperkyphosis in Postmenopausal Women

Development and Validation of a Multimodal Physiotherapy Framework to Prevent and Mitigate Postural Hyperkyphosis in Postmenopausal Women: A Randomized Controlled Trial

Postural hyperkyphosis is common in postmenopausal women and leads to spinal dysfunction, pain, impaired balance, and increased fall risk. This study aims to develop and validate a multimodal physiotherapy framework to prevent and manage hyperkyphosis in this population. A randomized controlled trial will be conducted at Allied Hospital with 72 postmenopausal women aged 40-75 years, divided into intervention (multimodal physiotherapy with conventional care) and control (conventional care only) groups.

Study Overview

• Status: Active, not recruiting
• Conditions: Hyperkyphosis
• Intervention / Treatment: Combination product: Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises; Diagnostic test: Standard Intervention (Control Group)

Detailed Description

The intervention includes strength, flexibility, postural correction, and balance training. The primary outcome is the change in Cobb's angle measured via radiographs; secondary outcomes include functional mobility and balance assessments using the Timed Up and Go Test, Berg Balance Scale, and Functional Reach Test. Data will be analyzed using SPSS v26. The study is expected to show significant improvements in spinal alignment, strength, balance, and reduced fall risk. The framework may offer a cost-effective, evidence-based approach for clinical and community rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Faisalābad, Punjab, Pakistan
      • Faisalabad Medical University (Allied Hospital Faisalabad)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Postmenopausal women aged 50-70 years.
• Kyphotic angle ≥40°, as measured by a flexicurve ruler or radiographic assessment.
• Postmenopausal for at least one year.
• Able to engage in rehabilitation exercises and follow instructions for physical activity..
• Living independently and capable of attending regular physiotherapy sessions.

Exclusion Criteria:

• Uncontrolled comorbidities such as cardiovascular disease, neurological disorders stroke or Parkinson's), or severe musculoskeletal conditions (e.g., advanced arthritis )
• History of spinal surgery within the last 6 months or spinal surgical implants. Severe osteoporosis (T-score < -2.5) and a history of multiple fractures.
• Pregnant or breastfeeding women. Cognitive impairments or mental health disorders that hinder adherence to the intervention.
• Inability to perform the exercises due to pain or disability.
• Participation in other rehabilitation or physiotherapy interventions for postural hyperkhyposis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises	Combination product: Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises; Interventions details (Group A) Strength Training Postural Correction Exercises Balance Training Exercises Flexibility Exercises:
Active Comparator: Standard Intervention (Control Group)	Diagnostic test: Standard Intervention (Control Group); The control group will receive standard physiotherapy for postural hyperkyphosis. The standard intervention will consist of: Postural education: Educating participants on proper posture, body mechanics, and ergonomics in daily activities. Basic stretching exercises targeting the thoracic spine and back muscles. Recommendations for low-impact aerobics activities (e.g., walking or cycling) to promote overall healthThe standard intervention will be delivered over the same 12-week period, with two sessions per week. This group will not receive the integrated multimodal framework with strength training, postural correction, balance training, and flexibility exercises that the experimental group receives. Duration and Frequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cobb's Angle	Cobb's Angle is a radiographic measurement used to assess spinal curvature in conditions like hyperkyphosis and scoliosis. It is calculated by identifying the most tilted vertebrae at the top and bottom of the curve on an X-ray. Straight lines are drawn along their endplates, and perpendiculars from these lines intersect to form the Cobb's Angle. A normal thoracic kyphosis ranges from 20° to 40°, while angles exceeding 40° in adults or 50° in postmenopausal women indicate hyperkyphosis. Severe cases (>60°) may require medical intervention. Regular follow-ups help monitor treatment effectiveness in reducing spinal curvature.	18 Months
Timed Up and Go (TUG) Test	The TUG test assesses mobility, balance, and fall risk in older adults. The patient starts seated in a chair, stands up, walks 3 meters (10 feet), turns around, walks back, and sits down. The time taken to complete the task is recorded in seconds. A score of <10 seconds indicates normal mobility, 10-20 seconds suggests mild mobility impairment, and >30 seconds signifies a high fall risk and functional dependence. It is a simple, reliable tool commonly used in rehabilitation settings.	18 Months
Berg Balance Scale (BBS)	The BBS is a 14-item test used to assess balance and fall risk in older adults and neurological patients. Each task, such as standing on one foot or reaching forward, is scored from 0 to 4, with a total score of 56. A score of 41-56 indicates low fall risk, 21-40 suggests moderate risk, and ≤20 signifies a high risk of falls. The test is widely used due to its strong reliability and validity in clinical practice.	18 Months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 7, 2025
• First Submitted That Met QC Criteria: July 7, 2025
• First Posted (Actual): July 16, 2025

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Kyphosis
• Other Study ID Numbers: PhDRSW/Batch-Fall23/2224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No