Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07068360

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hyperkyphosis Bone Diseases Kyphosis Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

35 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faisalabad Medical University (Allied Hospital Faisalabad)

Faisalābad, Punjab Province, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises

Combination Product

Interventions details (Group A) Strength Training Postural Correction Exercises Balance Training Exercises

Flexibility Exercises:

Standard Intervention (Control Group)

Diagnostic Test

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

Primary outcomes

  1. Cobb's Angle

    Time frame: 18 Months

    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.

  2. Timed Up and Go (TUG) Test

    Time frame: 18 Months

    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.

  3. Berg Balance Scale (BBS)

    Time frame: 18 Months

    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.

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.