- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05777538
Effects of Foot Exercises and Hydrotherapy on Pedal Edema & Lower Extremity Function
March 4, 2024 updated by: Riphah International University
Effects of Foot Exercises With and Without Hydrotherapy on Pedal Edema & Lower Extremity Function in Antenatal Women
To determine the Effects of foot exercises with and without hydrotherapy on pedal Edema & lower extremity function in antenatal women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
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 Locations
-
-
Punjab
-
Gujrat, Punjab, Pakistan, 05499
- Sajida Khalil Hospital Gujrat
-
-
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
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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 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: Foot exercise with 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
|
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.
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.
|
|
Active Comparator: Foot exercise
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Figure of 8 Method
Time Frame: 8th week
|
The figure of 8 method uses landmarks on the foot and ankle to measure the circumference of ankle in centimeters.
|
8th week
|
|
Lower Extremity Functional Scale
Time Frame: 8th week
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: hina gul, MSOMPT, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- .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
- Talbot L, Maclennan K. Physiology of pregnancy. Anaesthesia & Intensive Care Medicine. 2016;17(7):341-5
- 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
- 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
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)
October 1, 2022
Primary Completion (Actual)
July 1, 2023
Study Completion (Actual)
August 1, 2023
Study Registration Dates
First Submitted
March 8, 2023
First Submitted That Met QC Criteria
March 8, 2023
First Posted (Actual)
March 21, 2023
Study Record Updates
Last Update Posted (Estimated)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0511
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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