Clinical trial NCT04528121: Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis
Official title: Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: CoDuSe
balance
step square exercises
risk of fall
Multiple Sclerosis
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Biodex balance system
timeFrame: 4 weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: 4 weeks
measure: Morse Fall Scale
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 University
state: El-Sheikh Zayed City Giza 1133 Egypt
Study officials:
affiliation: Cairo University
name: Lama S Mahmoud
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer,Department of physical therapy for Neuromuscular Disorders & its surgery / Faculty of physical therapy/ October 6 university
name: Lama S Mahmoud, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of physical therapy for neuromuscular disorders and its surgeries, modern university for technology & information (MTI) Egypt
name: Hanan H Mohamed, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant professor, Department of Biomechanics, faculty of physical therapy, Cairo university
name: Sobhy M Aly, PHD
role: PRINCIPAL_INVESTIGATOR
References: