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

NCT04528121 | Completed DMC

• 1 other identifier: P.T. REC/012/002865
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

CoDuSe; balance; step square exercises; risk of fall; Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

study group

EXPERIMENTAL

(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; Other: conventional balance training

control group

EXPERIMENTAL

the conventional selected exercise program inform of static and dynamic balance training exercises

Other: conventional balance training

Interventions

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.

study group

conventional balance training OTHER

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

control group; study group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lama Saad El-Din Mahmoud: lead

Study Sites (1)

October 6 University

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

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity

Model Details: control group which received conventional selected exercise program in form of static and dynamic balance training exercises and 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.

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: August 27, 2020
• Study Start: September 15, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)