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

NCT ID: NCT04528121

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2020-12-30

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?

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CoDuSe balance training and step square exercises

Intervention Type: 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

Intervention Type: OTHER

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

control group

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

Group Type: EXPERIMENTAL

conventional balance training

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

conventional balance training

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lama Saad El-Din Mahmoud

OTHER

Sponsor Role: lead

Responsible Party

Lama Saad El-Din Mahmoud

Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lama S Mahmoud

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Lama S Mahmoud, PHD

Role: PRINCIPAL_INVESTIGATOR

Lecturer,Department of physical therapy for Neuromuscular Disorders & its surgery / Faculty of physical therapy/ October 6 university

Hanan H Mohamed, PHD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of physical therapy for neuromuscular disorders and its surgeries, modern university for technology & information (MTI) Egypt

Sobhy M Aly, PHD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor, Department of Biomechanics, faculty of physical therapy, Cairo university

Locations

October 6 University

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

Countries

Egypt

Other Identifiers

P.T. REC/012/002865

Identifier Type: -

Identifier Source: org_study_id