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Completed

NCT Number: NCT04528121

Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis

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?

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

October 6 University

Giza, El-Sheikh Zayed City Giza 1133 Egypt, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CoDuSe balance training and step square exercises

Other

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.

Conventional balance training

Other

static and dynamic balance training exercises from sitting, standing and ambulation activities

Primary outcomes

  1. Biodex balance system

    Time frame: 4 weeks

    fast, accurate Fall Risk Screening and Conditioning Programme

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Lama Saad El-Din Mahmoud

Other

Registry information

Acronym: core stability

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 27, 2020
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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