Back to resultsEffect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis (core stability)
Primary Purpose
Multiple Sclerosis, Relapsing-Remitting
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
CoDuSe balance training and step square exercises
conventional balance training
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring CoDuSe, balance, step square exercises, risk of fall, Multiple Sclerosis
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
Sites / Locations
- October 6 University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
study group
control group
Arm Description
(CoDuSe) exercise inform of core stability, dual tasking, and sensory strategies the conventional selected exercise program inform of static and dynamic balance training exercises
the conventional selected exercise program inform of static and dynamic balance training exercises
Outcomes
Primary Outcome Measures
Biodex balance system
fast, accurate Fall Risk Screening and Conditioning Programme
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04528121
First Posted
August 22, 2020
Last Updated
February 22, 2021
Sponsor
Lama Saad El-Din Mahmoud
1. Study Identification
Unique Protocol Identification Number
NCT04528121
Brief Title
Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis
Acronym
core stability
Official Title
Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lama Saad El-Din Mahmoud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
CoDuSe, balance, step square exercises, risk of fall, Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
(CoDuSe) exercise inform of core stability, dual tasking, and sensory strategies the conventional selected exercise program inform of static and dynamic balance training exercises
Arm Title
control group
Arm Type
Experimental
Arm Description
the conventional selected exercise program inform of static and dynamic balance training exercises
Intervention Type
Other
Intervention Name(s)
CoDuSe balance training and step square exercises
Intervention Description
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
Intervention Name(s)
conventional balance training
Intervention Description
static and dynamic balance training exercises from sitting, standing and ambulation activities
Primary Outcome Measure Information:
Title
Biodex balance system
Description
fast, accurate Fall Risk Screening and Conditioning Programme
Time Frame
4 weeks
Title
Short Physical Performance Battery (SPPB)
Description
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.
Time Frame
4 weeks
Title
Morse Fall Scale
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lama S Mahmoud
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lama S Mahmoud, PHD
Organizational Affiliation
Lecturer,Department of physical therapy for Neuromuscular Disorders & its surgery / Faculty of physical therapy/ October 6 university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanan H Mohamed, PHD
Organizational Affiliation
Lecturer of physical therapy for neuromuscular disorders and its surgeries, modern university for technology & information (MTI) Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sobhy M Aly, PHD
Organizational Affiliation
Assistant professor, Department of Biomechanics, faculty of physical therapy, Cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
October 6 University
City
Giza
State/Province
El-Sheikh Zayed City Giza 1133 Egypt
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis
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