- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07148479
- Original Trial
Telerehabilitation Versus Traditional Balance Training in Women With Osteoporosis.
Comparison of Telerehabilitation and Traditional Balance Training in Post Menopausal Women With Osteoporosis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Osteoporosis often remains undetected until fractures occur, typically involving the hip, wrist, or spine, and may also cause back pain, height loss, and kyphosis. Postmenopausal women face increased fall risk due to reduced bone density, weakened lower limb muscles, and altered posture. Many also develop fear of falling, which restricts activity and accelerates muscle weakness.
Globally, osteoporosis affects about 23.1% of women and 11.7% of men, with fragility fractures being a major cause of disability. In Pakistan, hospital-based findings show a high proportion of postmenopausal women as severely osteoporotic, with a strong link to fall-related injuries.
Exercise interventions, including balance, resistance, and weight-bearing training, are known to improve bone strength, postural control, and confidence by stimulating bone remodelling and enhancing musculoskeletal performance. Telerehabilitation, delivered via video conferencing, provides remote access to such programs and has demonstrated improvements in stability, weight-shifting, and functional balance.
However, most studies assess limited outcomes using tools like TUG or BBS, without addressing static, dynamic, anticipatory, and reactive balance together. Evidence largely comes from high-income countries, while data from resource-limited settings like Pakistan remain scarce. This trial seeks to evaluate telerehabilitation compared to traditional training across comprehensive balance domains in postmenopausal women with osteoporosis.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Prof. Dr. Huma Riaz
- Phone Number: +92 3215242874
- Email: huma.riaz@riphah.edu.pk
Study Locations
-
-
ICT
-
Islamabad, ICT, Pakistan
- Riphah International Hospital
-
Contact:
- Dr. Ammara Malik
- Phone Number: +92 3145326065
- Email: ammara.malik@riphah.edu.pk
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Principal Investigator:
- Mehak Bibi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Women diagnosed with osteopenia and osteoporosis at hip and lumbar spine through DEXA
- Age 50-70 years
- Have mobile phones and can communicate in video call
- Have Balance score (21-44) on berg balance scale
- A caregiver must be available to assist the participant during Tele sessions.
Exclusion Criteria:
• Women with severe mobility impairments.
- Women with cognitive conditions affecting participation.
- Women with lower limb joint injury or surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telerehabilitation group
This group will receive a 6 week structured telerehabilitation exercise protocol of low to moderate intensity (18 sessions , 3 sessions per week,45 to 60 minutes ), warmup, balance training and cool down exercises.
delivered online by a physiotherapist and progressively increasing every three weeks.
|
The telerehabilitation group participated in balance training sessions delivered through secure virtual platforms such as WhatsApp video calls.
Participants completed 3 sessions per week, each lasting 45-60 minutes, over a total of 6 weeks (18 sessions).
The program target static, dynamic, anticipatory, and reactive balance.
participants will use households items.session
began with warm-up exercises such as gentle marching, arm circles, and hamstring stretches, followed by balance training targeting static, dynamic, anticipatory, and reactive components.
Exercises included heel-to-toe standing, single-leg stance, tandem stance, obstacle walking, heel-to-toe walking, side stepping, functional reach, weight shifting, caregiver-assisted perturbations, and foam surface standing.
All exercises were performed in 3 sets with specified holds or repetitions.
Sessions concluded with cool-down activities including tricep stretches, forward bends, and deep breathing.
|
|
Active Comparator: Traditional Balance Training group
In the traditional balance training group the protocol will be delivered by a physiotherapist in a clinical environment face to face.
The standardized balance training protocol will be monitored exactly the same as telerehabilitation group
|
Same as telerehabilitation group but it will concluded in a clinical setting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Berg Balance Scale score
Time Frame: Baseline and 6 weeks
|
The Berg Balance Scale (BBS) is a widely used clinical tool to assess static and dynamic balance in individuals, particularly older adults.
It's a 14-item test that evaluates a person's ability to perform various balance-related tasks, such as sitting, standing, reaching, and turning.
Each item is scored on a 0-4 scale, with 0 indicating the lowest level of function and 4 indicating the highest.
The total score ranges from 0 to 56, with lower scores suggesting a higher risk of falls
|
Baseline and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Time up and Go test score
Time Frame: Baseline and 6 weeks
|
The Timed Up and Go Test (TUG) is a simple yet widely validated tool used to assess mobility and fall risk.
It measures how quickly an individual can rise from a chair, walk three meters, turn, walk back, and sit down
|
Baseline and 6 weeks
|
|
Functional reach test
Time Frame: Baseline and 6 weeks
|
The Functional Reach Test (FRT) assesses how far an individual can reach forward while standing, without stepping or losing balance.
It's particularly effective for identifying balance limitations in frail or elderly populations
|
Baseline and 6 weeks
|
|
Change in Push and release test score
Time Frame: Baseline and 6 weeks
|
Push and Release Test is designed to measure reactive postural control by observing how a person recovers after being released from a supported backward lean.
|
Baseline and 6 weeks
|
|
Change in Single leg stance test score
Time Frame: Baseline and 6 weeks
|
The Single Leg Stance Test (SLS) is a simple but powerful tool to evaluate balance and stability, particularly in older adults or individuals with conditions like osteoporosis.
In this test, the person is asked to stand on one leg usually with eyes open and hands on hips while the clinician times how long they can maintain that position without support.
It's an effective way to spot balance problems that could lead to falls
|
Baseline and 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Prof. Dr. Huma Riaz, Riphah International University
Publications and helpful links
General Publications
- Li S, Li Y, Liang Q, Yang WJ, Zi R, Wu X, Du C, Jiang Y. Effects of tele-exercise rehabilitation intervention on women at high risk of osteoporotic fractures: study protocol for a randomised controlled trial. BMJ Open. 2022 Nov 7;12(11):e064328. doi: 10.1136/bmjopen-2022-064328.
- Rezaei MK, Torkaman G, Bahrami F, Bayat N. The effect of six week virtual reality training on the improvement of functional balance in women with type-I osteoporosis: A preliminary study. Sport Sci Health. 2023;19(1):185-194. doi: 10.1007/s11332-022-01018-8. Epub 2022 Nov 15.
- Wei F, Hu Z, He R, Wang Y. Effects of balance training on balance and fall efficacy in patients with Osteoporosis: A systematic review and meta-analysis with trial sequential analysis. J Rehabil Med. 2023 May 17;55:jrm00390. doi: 10.2340/jrm.v55.4529.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mehak bibi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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