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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05777538
Other study ID # REC/RCR&AHS/23/0511
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date August 1, 2023

Study information

Verified date March 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the Effects of foot exercises with and without hydrotherapy on pedal Edema & lower extremity function in antenatal women.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date August 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Normal singleton pregnancy - Gestational age 30-40 weeks - Pitting edema in feet Exclusion Criteria: - presence of any under lying disease e.g. - Diabetes, - Hypertension, - High risk pregnancy - Any wound or skin lesion

Study Design


Related Conditions & MeSH terms


Intervention

Other:
hydrotherapy
Hydrotherapy will be performed by immersing the women's foot in a container filled with 3 liters water with a temperature of 30-32°C. The water level must cover the women's feet up to ankle. During the immersion the therapist will ask the women to perform exercise with legs being fully supported, then alternatively stretch and flex the ankle for 30 times. which will be followed by circling each foot at ankle in clock wise and anticlock wise direction, 30 times each. The duration of water immersion session will be (30 min) for 5 consecutive days.
foot exercises
The therapist will ask the women to perform exercise with legs being fully supported, then alternatively stretch and flex the ankle for 30 times. which will be followed by circling each foot at ankle in clock wise and anticlock wise direction, 30 times each.

Locations

Country Name City State
Pakistan Sajida Khalil Hospital Gujrat Gujrat Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

.MACWAN KR, Savaliya PK. Effectiveness of Foot Exercise and Epsom Salt Water on Reduction of Foot Oedema among Antenatal Mothers. Journal of Clinical & Diagnostic Research. 2021;15

Ahmed AH, Ismail NIAA, Hassan NMM. Effect of effleurage massage versus water immersion with exercise on physiological foot edema among primigravidae. Egypt J Health Care. 2021;12(2):56-345

Patola A, Tridiyawati F. The Effectiveness of Soaking the Feet in Salt Water to Reduce the Degree of Edema in Pregnant Women Trimester III. Jurnal Keperawatan Komprehensif (Comprehensive Nursing Journal). 2022;8

Talbot L, Maclennan K. Physiology of pregnancy. Anaesthesia & Intensive Care Medicine. 2016;17(7):341-5

Outcome

Type Measure Description Time frame Safety issue
Primary Figure of 8 Method The figure of 8 method uses landmarks on the foot and ankle to measure the circumference of ankle in centimeters.
the point midway over the anterior ankle between the tibialis anterior tendon and lateral malleolus,
the navicular tuberosity,
the base of the fifth metatarsal, and
the inferior tip of the medial malleolus
8th week
Primary Lower Extremity Functional Scale The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used to evaluate the functional status of lower limb 8th week
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