NCT06976164

Brief Summary

The purpose of this study will be to detect the effects of Reflexo therapy of sole on GDM.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started May 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
May 2025Jun 2026

Study Start

First participant enrolled

May 1, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

May 8, 2025

Last Update Submit

May 8, 2025

Conditions

Physical Therapy

Keywords

Gestational diabetes mellitusFoot reflexologyFasting plasma glucose2-h post-prandial glucoseHbA1c

Outcome Measures

Primary Outcomes (2)

  • Change in The Oral Glucose Tolerance Test.

    Change from Baseline Oral Glucose Tolerance Test at one month

  • Change in The Hemoglobin A1C Test.

    Change from Baseline Hemoglobin A1C Test at one month

Study Arms (2)

Experimental Group A

EXPERIMENTAL
Procedure: The standard antenatal care.Procedure: Foot reflexology.

Experimental Group B

EXPERIMENTAL
Procedure: The standard antenatal care.

Interventions

The standard antenatal care.PROCEDURE

Antenatal Protocol.

Experimental Group AExperimental Group B
Foot reflexology.PROCEDURE

A manual therapy technique.

Experimental Group A

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • They had high-risk pregnancies.
  • Bad obstetric situations.
  • Diseases that could interfere with participation.
  • Smoking.
  • Oral sedative administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh University.

Cairo, Egypt

RECRUITING

The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh University.

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Yomna E Ghanem, M.Sc.

CONTACT

+201011501343youmna.ezz_a012@pt.kfs.edu.eg

Fayiz F Elshamy, PhD

CONTACT

+201091050154fayez_elshamy2014@pt.kfs.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator

Study Record Dates

First Submitted

May 8, 2025

First Posted

May 16, 2025

Study Start

May 1, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)