HyperkyphosisNCT07068360
Development and Validation of MPF to Prevent and Mitigate Postural Hyperkyphosis in Postmenopausal Women
A study testing Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises in people with Hyperkyphosis, run by Superior University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Hyperkyphosis
- What is being tested?
- Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Apr 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Faisalabad Medical University (Allied Hospital Faisalabad)
Faisalābad, Punjab Province
About this study
Official title: 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.
Read the 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
- Conditions
- Hyperkyphosis
- Being tested
- Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises, Standard Intervention (Control Group)
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength Training +Postural Correction Exercises + Balance Training +Flexibility ExercisesCombination 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
| Study group | Role | What they receive |
|---|---|---|
| Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises | Experimental | Not described Receives: Combination Product: Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises |
| Standard Intervention (Control Group) | Active comparator | Not described Receives: Diagnostic Test: Standard Intervention (Control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start17 Apr 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkyphosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068360
- Sponsor's protocol ID
- PhDRSW/Batch-Fall23/2224
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Multimodal Physiotherapy Framework to Prevent and Mitigate Postural Hyperkyphosis in Postmenopausal Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07068360
- Acronym / sponsor ID
- PhDRSW/Batch-Fall23/2224
- Conditions
- Hyperkyphosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises | Experimental | Combination Product: Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises |
| Standard Intervention (Control Group) | Active comparator | Diagnostic Test: Standard Intervention (Control Group) |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength Training +Postural Correction Exercises + Balance Training +Flexibility ExercisesInterventions details (Group A) Strength Training Postural Correction Exercises Balance Training Exercises Flexibility Exercises: | Combination product | Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises |
| 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 | Diagnostic test | Standard Intervention (Control Group) |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises in people with Hyperkyphosis, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb's Angle (time frame: 18 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.