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

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: Completed
• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: Other: CoDuSe balance training and step square exercises; Other: conventional balance training

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: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Biodex balance system	fast, accurate Fall Risk Screening and Conditioning Programme	4 weeks
Short Physical Performance Battery (SPPB)	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	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

• Sponsor: Lama Saad El-Din Mahmoud
• Investigators: 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

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: August 22, 2020
• First Submitted That Met QC Criteria: August 22, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; balance; CoDuSe; step square exercises; risk of fall
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID 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