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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04528121
Other study ID # P.T. REC/012/002865
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date December 30, 2020

Study information

Verified date February 2021
Source October 6 University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt October 6 University Giza El-Sheikh Zayed City Giza 1133 Egypt

Sponsors (1)

Lead Sponsor Collaborator
Lama Saad El-Din Mahmoud

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biodex balance system fast, accurate Fall Risk Screening and Conditioning Programme 4 weeks
Primary 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
Primary 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
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