Effect of l S Exercises on Balance and Spatiotemporal Gait Parameters in P M Women

August 21, 2022 updated by: Hend Hamdy

Effect of Lumbar Stabilization Exercises on Balance and Spatiotemporal Gait Parameters in Postmenopausal Women

Menopause is a natural process in women's life with hormonal fluctuations that cause physical and emotional symptoms such as(Hot flashes, insomnia, physical in activity, unstable mood, difficulties in memory and concentration, anxiety, stress, irritability, unstable body mass, sexual dysfunction, feelings of sadness, infertility, and depression).

Balance disturbances are common in the community as a whole and increase in frequency with age. The risk of falling increases from age 45 in women and peaks in the 55-59-year age group. Around the time of the menopause, estrogen production decreases dramatically and bone loss accelerates, which predisposes for fractures if a fall occurs.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Anticipated)

30

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

Study Contact Backup

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

45 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Post-menopausal women: Their age will be ranged between 45-59 years old, with low back pain.

Exclusion Criteria:

  • Infection disease or fever.
  • Foot ulcers.
  • Foot infection or undergoing foot surgery.
  • Recent fracture in foot and toes with unhealed wounds.
  • Thrombotic disease of lower extremities.
  • Deep proprioception loss.
  • Peripheral neuropathy.
  • Gout or advanced arthritis affecting the foot and toes.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group (A)
Group (A): will receive lumbar stabilization exercises
selected exercises will taught to participant and practiced 3 times per week for 6 weeks
No Intervention: Group (B)
Group (B): will be control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Step length
Time Frame: about 6 weeks.
the distance between the point of initial contact of one foot and the point of initial contact of the opposite foot measured by cm
about 6 weeks.
step symmetry
Time Frame: about 6 weeks.
right to left time distribution measured by second
about 6 weeks.
walking speed
Time Frame: about 6 weeks.
the ratio of distance to the time in which the distance was covered by the subject measured by m/s
about 6 weeks.

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 (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

July 23, 2021

First Submitted That Met QC Criteria

August 14, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 21, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • p.T.RCE/012/003190

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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