Physical TherapyNCT06976164
Reflexo Therapy for Gestational Diabetes Mellitus
A study testing The standard antenatal care. and Foot reflexology. in people with Physical Therapy, run by Kafrelsheikh University at 2 sites in Egypt.
Trial summary
The purpose of this study will be to detect the effects of Reflexo therapy of sole on GDM. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Physical Therapy
- What is being tested?
- The standard antenatal care. and Foot reflexology.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- They were maternally aged between 20 and 35 years.
- The gestational age ranged from between 24 and 36 weeks.
- Their BMI didn't exceed 30 kg/m2.
- A singleton live fetus and not under stressful event.
Who cannot join
- They had high-risk pregnancies.
- Bad obstetric situations.
- Diseases that could interfere with participation.
- Smoking.
- Oral sedative administration.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh University.
Cairo
Eman A Elhosary, PhD, +201276754277, emanabdelfatah123@yahoo.com
- Recruiting
The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh University.
Cairo
About this study
Official title: The Effects of Reflexo Therapy of Sole on Gestational Diabetes Mellitus
The purpose of this study will be to detect the effects of Reflexo therapy of sole on GDM.
Read the detailed description
Gestational diabetes mellitus is considered a hazard factor for antenatal complications for both mother and fetus. It is characterized by glucose intolerance of variable degrees with the beginning or first recognition of pregnancy. It affects 14% of pregnancies worldwide, and it undergoes continuous changes in the diagnostic criteria, ethnicity and the population studied.
There is an increasing prevalence of diabetes mellitus, and its major metabolic disorder caused by the insulin secretion defect or insulin action defect resulting from a defect in insulin secretion, insulin action, or both. As a result, it will lead to chronic hyperglycemia associated with carbohydrates, protein, and fat disturbance.
In spite of the fact that the reason for gestational diabetes mellitus is still not fully understood, it is proposed that human placental lactogen has growth hormone-like actions, and that it causes lipolysis and thus increases the levels of circulating fatty acids that repress the action of insulin and cause insulin resistance in pregnant females which appear to play a crucial role in the pathogenesis of gestational diabetes mellitus.
- Conditions
- Physical Therapy
- Being tested
- The standard antenatal care., Foot reflexology.
- Keywords
- Gestational diabetes mellitus, Foot reflexology, Fasting plasma glucose, 2-h post-prandial glucose, HbA1c
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The standard antenatal care.Procedure or surgery
Antenatal Protocol.
Foot reflexology.Procedure or surgery
A manual therapy technique.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group A | Experimental | Not described Receives: Procedure: The standard antenatal care.; Procedure: Foot reflexology. |
| Experimental Group B | Experimental | Not described Receives: Procedure: The standard antenatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Oral Glucose Tolerance Test.
Measured: Change from Baseline Oral Glucose Tolerance Test at one month
Change in The Hemoglobin A1C Test.
Measured: Change from Baseline Hemoglobin A1C Test at one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 May 2025
- Primary completion1 Jan 2026 (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 Physical TherapyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna Ghanem, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976164
- Sponsor's protocol ID
- P.T. 2024-2025
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 16 May 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Reflexo Therapy of Sole on Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06976164
- Acronym / sponsor ID
- P.T. 2024-2025
- Conditions
- Physical Therapy
- Keywords
- Gestational diabetes mellitus, Foot reflexology, Fasting plasma glucose, 2-h post-prandial glucose, HbA1c
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 16 May 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.
The purpose of this study will be to detect the effects of Reflexo therapy of sole on GDM.
Detailed description
Gestational diabetes mellitus is considered a hazard factor for antenatal complications for both mother and fetus. It is characterized by glucose intolerance of variable degrees with the beginning or first recognition of pregnancy. It affects 14% of pregnancies worldwide, and it undergoes continuous changes in the diagnostic criteria, ethnicity and the population studied.
There is an increasing prevalence of diabetes mellitus, and its major metabolic disorder caused by the insulin secretion defect or insulin action defect resulting from a defect in insulin secretion, insulin action, or both. As a result, it will lead to chronic hyperglycemia associated with carbohydrates, protein, and fat disturbance.
In spite of the fact that the reason for gestational diabetes mellitus is still not fully understood, it is proposed that human placental lactogen has growth hormone-like actions, and that it causes lipolysis and thus increases the levels of circulating fatty acids that repress the action of insulin and cause insulin resistance in pregnant females which appear to play a crucial role in the pathogenesis of gestational diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group A | Experimental | Procedure: The standard antenatal care., Procedure: Foot reflexology. |
| Experimental Group B | Experimental | Procedure: The standard antenatal care. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- They were maternally aged between 20 and 35 years.
- The gestational age ranged from between 24 and 36 weeks.
- Their BMI didn't exceed 30 kg/m2.
- A singleton live fetus and not under stressful event.
Key exclusion criteria (5 listed)
- They had high-risk pregnancies.
- Bad obstetric situations.
- Diseases that could interfere with participation.
- Smoking.
- Oral sedative administration.
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 |
|---|---|---|
| The standard antenatal care.Antenatal Protocol. | Procedure or surgery | Experimental Group A, Experimental Group B |
| Foot reflexology.A manual therapy technique. | Procedure or surgery | Experimental Group A |
Primary outcome
Change in The Oral Glucose Tolerance Test.
Time frame: Change from Baseline Oral Glucose Tolerance Test at one month
Change in The Hemoglobin A1C Test.
Time frame: Change from Baseline Hemoglobin A1C Test at one month
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 May 2025.
- Individual participant dataSharing planned: No
Related trials for Physical Therapy
Not yet recruitingEarly Phase 1
Multiparametric Metabolic and Hypoxic PET/MRI Imaging Substudy in Gliomas
Glioma
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Not yet recruiting
Kinesitherapy Plus Osteopathy After Surgery for Dupuytren Disease
Dupuytren Disease
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Recruiting
Effects of Scapular Training on Adolescent Boxers
Sports Physical Therapy
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The standard antenatal care. and Foot reflexology. in people with Physical Therapy, run by Kafrelsheikh University at 2 sites in Egypt.
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 4 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: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Contact Yomna E Ghanem, M.Sc. (+201011501343, youmna.ezz_a012@pt.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in The Oral Glucose Tolerance Test. (time frame: Change from Baseline Oral Glucose Tolerance Test at one month). The study lists 2 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 May 2025.