- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07333989
Effect of Biofeedback Activation on Balance in Osteoporotic Elderly
March 18, 2026 updated by: Mohamed Said Alsafy Alhamrawy
Effect of Biofeedback Activation on Balance in Osteoporotic Elderly Patients
This study aimed to investigate the effect of gluteus medius activation using electromyography (EMG) biofeedback combined with balance training on balance, physical performance, gluteus medius muscle activity, and quality of life in osteoporotic elderly patients.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed Alhamrawy
- Phone Number: +201013132649
- Email: Mohamedalhamrawy333@gmail.com
Study Locations
-
-
-
Abū Ḩummuş, Egypt, 045
- Recruiting
- General Hospital Abouhms
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
All patients included in this study met the following criteria:
- Sixty patients of both sexes were diagnosed with osteoporosis confirmed by bone density test through Dual-energy X-ray absorptiometry (DEXA) scan (A T-score equal to or less than - 2.5) (Sheu and Diamond, 2016).
- Their age ranged between 65 - 75 years.
- Their BMI ranged between 25 - 29.9 kg/m2.
- They had good mentality and cognitive function.
Exclusion Criteria:
The potential patients were excluded if they have one of the following criteria:
- Patients with endocrine disorders likely to be related to metabolic bone disease, such as premature ovarian failure, hypogonadism, untreated hyperthyroidism, hyperparathyroidism, adrenal insufficiency or Cushing's syndrome.
- Patients with active contagious skin conditions.
- Patients with implant devices such as pacemaker or electrical prosthesis.
- Any cardiopulmonary disorders.
- Any neuromuscular disorders.
- Any acute viral infection.
- Patients with ascites or end stage liver or kidney failure.
- Leg discrepancy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gluteus medius isometric strengthening using EMG with traditional balance training
received 30 minutes of traditional balance training (functional strength, static and dynamic balance, and gait training) followed by 30 minutes of gluteus medius isometric strengthening using EMG biofeedback, three times per week, for four consecutive weeks.
|
a physical therapy intervention that uses auditory and visual feedback to control the contraction or relaxation of muscles.
Repeated biofeedback training can induce motor learning of muscles.
Biofeedback enhances the function of pelvic floor muscles by enhancing the force generation, correct timing, and coordination of the pelvic floor muscles.
Electromyography Biofeedback is considered as a behavioural therapy training modality
|
|
Active Comparator: Traditional balance training only
received balance training alone with the same frequency and duration.
|
functional strength, static and dynamic balance, and gait training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: Base line before treatment, then one month after treatment
|
balance of osteoporotic elderly patients (antero-posterior, medio-lateral, and overall stability indices; Berg Balance Scale)
|
Base line before treatment, then one month after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
gluteus medius activity
Time Frame: Base line before treatment and reassessment after one month of treatment
|
Assessment of gluteus medius strength by hand-held dynamometer
|
Base line before treatment and reassessment after one month of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2026
Primary Completion (Estimated)
April 5, 2026
Study Completion (Estimated)
May 1, 2026
Study Registration Dates
First Submitted
December 30, 2025
First Submitted That Met QC Criteria
December 30, 2025
First Posted (Actual)
January 12, 2026
Study Record Updates
Last Update Posted (Actual)
March 20, 2026
Last Update Submitted That Met QC Criteria
March 18, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Bone Diseases
- Musculoskeletal Diseases
- Metabolic Diseases
- Bone Diseases, Metabolic
- Nutritional and Metabolic Diseases
- Osteoporosis
- Therapeutics
- Diagnostic Techniques and Procedures
- Diagnosis
- Mind-Body Therapies
- Complementary Therapies
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Feedback, Psychological
- Electrodiagnosis
- Myography
- Electromyography
- Biofeedback, Psychology
Other Study ID Numbers
- P.T.REC/012/005451
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
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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