Multiple Sclerosis, Relapsing-Remittingcore stabilityNCT04528121
Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis
A study testing CoDuSe balance training and step square exercises and conventional balance training in people with Multiple Sclerosis, Relapsing-Remitting, run by Lama Saad El-Din Mahmoud at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- CoDuSe balance training and step square exercises and conventional balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read the 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
- Being tested
- CoDuSe balance training and step square exercises, conventional balance training
- Keywords
- CoDuSe, balance, step square exercises, risk of fall, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoDuSe balance training and step square exercisesOther
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 trainingOther
static and dynamic balance training exercises from sitting, standing and ambulation activities
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: conventional balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex balance system
fast, accurate Fall Risk Screening and Conditioning Programme
Measured: 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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start15 Sep 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lama Saad El-Din Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lama Saad El-Din Mahmoud, October 6 University
- Investigators
- Lama S Mahmoud, Principal investigator, Cairo UniversityLama S Mahmoud, PHD, Principal investigator, Lecturer,Department of physical therapy for Neuromuscular Disorders & its surgery / Faculty of physical therapy/ October 6 universityHanan H Mohamed, PHD, Principal investigator, Lecturer of physical therapy for neuromuscular disorders and its surgeries, modern university for technology & information (MTI) EgyptSobhy M Aly, PHD, Principal investigator, Assistant professor, Department of Biomechanics, faculty of physical therapy, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528121
- Sponsor's protocol ID
- P.T. REC/012/002865
- Acronym
- core stability
- Status last verified
- Feb 2021
- First submitted
- 22 Aug 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04528121
- Acronym / sponsor ID
- core stability / P.T. REC/012/002865
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- CoDuSe, balance, step square exercises, risk of fall, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Lama Saad El-Din MahmoudUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: CoDuSe balance training and step square exercises, Other: conventional balance training(CoDuSe) exercise inform of core stability, dual tasking, and sensory strategies the conventional selected exercise program inform of static and dynamic balance training exercises |
| control group | Experimental | Other: conventional balance trainingthe conventional selected exercise program inform of static and dynamic balance training exercises |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoDuSe balance training and step square exercisesThe 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. | Other | study group |
| conventional balance trainingstatic and dynamic balance training exercises from sitting, standing and ambulation activities | Other | control group, study group |
Primary outcome
Biodex balance system
Time frame: 4 weeks
fast, accurate Fall Risk Screening and Conditioning Programme
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lama S Mahmoud principal investigator
Cairo University
Lama S Mahmoud, PHD principal investigator
Lecturer,Department of physical therapy for Neuromuscular Disorders & its surgery / Faculty of physical therapy/ October 6 university
Hanan H Mohamed, PHD principal investigator
Lecturer of physical therapy for neuromuscular disorders and its surgeries, modern university for technology & information (MTI) Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoDuSe balance training and step square exercises and conventional balance training in people with Multiple Sclerosis, Relapsing-Remitting, run by Lama Saad El-Din Mahmoud at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex balance system (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.