Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis (core stability)

February 22, 2021 updated by: Lama Saad El-Din Mahmoud

To investigate the effect of CoDuSe balance training and step square exercises on the risk of falls in multiple sclerosis. BACKGROUND: risk of fall & balance disabilities are considered serious problems in multiple sclerosis which results in loss of balance & physical inactivity.

………HYPOTHESES:

This study hypothesized that:

CoDuSe balance training and step square exercises will have a significant effect on the risk of falling in multiple sclerosis

RESEARCH QUESTION:

Is there an effect of CoDuSe balance training and step square exercises on risk of fall in multiple sclerosis?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Fifty-two patients with multiple sclerosis will participate in this study.

The patients will randomly be divided into two equal groups; the control group which received the conventional selected exercise program and the study group received the same exercise training program in addition to CoDuSe balance training and step square exercises, three times per week for four weeks.

The Evaluation will done pre and post interventions included:

Biodex balance system (Risk falling), Short Physical Performance Battery (SPPB) & Morse Fall Scale.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Egypt
    • El-Sheikh Zayed City Giza 1133 Egypt
      • Giza, El-Sheikh Zayed City Giza 1133 Egypt, Egypt
        • October 6 University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fifty-two Remitting-relapsing multiple sclerosis RRMS patients,
  • Age will range as (20:40) years old
  • Illness duration not more than 10 years,
  • with no relapses over the past three months,
  • body mass index (25:35)

Exclusion Criteria:

  • difficulty to communicate or to understand program instructions
  • any other neurological deficits or orthopedic abnormalities,
  • secondary musculoskeletal complication
  • peripheral vestibulopathy, hepatic, renal, hemopoeitic, thyroid and cardiovascular diseases, cognitive dysfunction,
  • hearing deficits, epilepsy or EEG abnormalities

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: study group
(CoDuSe) exercise inform of core stability, dual tasking, and sensory strategies the conventional selected exercise program inform of static and dynamic balance training exercises
Other: CoDuSe balance training and step square exercises

The standardized intervention targeted visual, somatosensory, and vestibular aspects of balance and will be included with balance exercises

Examples of core stability exercises as follows: in supine position with knees bent, slowly slide one heel forward to straighten leg; and, in four-point kneeling position, slide one foot in a straight line away from the body and lift the leg off the floor.

Examples of dual-task exercises as walking while turning one's head and juggling a balloon.

Examples of sensory strategies as standing and walking on uneven surfaces and standing with eyes closed.

Other: conventional balance training
static and dynamic balance training exercises from sitting, standing and ambulation activities
Experimental: control group
the conventional selected exercise program inform of static and dynamic balance training exercises
Other: conventional balance training
static and dynamic balance training exercises from sitting, standing and ambulation activities

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biodex balance system
Time Frame: 4 weeks
fast, accurate Fall Risk Screening and Conditioning Programme
4 weeks
Short Physical Performance Battery (SPPB)
Time Frame: 4 weeks

The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests . It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people.

The Short Physical Performance Battery (SPPB)test is designed to measure functional status and physical performance.
4 weeks
Morse Fall Scale
Time Frame: 4 weeks
The Morse Fall Scale (MFS) is a rapid and simple method of assessing a patient's likelihood of falling A patient who scores under 25 points is considered to be at low risk of falling, a patient who scores between 25-45 points is considered to be at moderate risk of falling, and a patient who scores higher than 45 points is considered to be at high risk of falling.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lama Saad El-Din Mahmoud

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lama S Mahmoud, Cairo university
  • Principal Investigator: Lama S Mahmoud, PHD, Lecturer,Department of physical therapy for Neuromuscular Disorders & its surgery / Faculty of physical therapy/ October 6 university
  • Principal Investigator: Hanan H Mohamed, PHD, Lecturer of physical therapy for neuromuscular disorders and its surgeries, modern university for technology & information (MTI) Egypt
  • Principal Investigator: Sobhy M Aly, PHD, Assistant professor, Department of Biomechanics, faculty of physical therapy, Cairo university

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T. REC/012/002865

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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