- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06524089
Pilates Versus Eccentric Exercises on Multiple Sclerosis (MS)
Pilates Versus Eccentric Exercises in Chronic Low Back Pain With Multiple Sclerosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Thirty adult patients with multiple sclerosis with chronic NSLBP verified diagnosis of MS by a specialized neurologist will be questioned and screened according to inclusion and exclusion criteria.
Patients were randomly allocated to one of two groups: (Pilates or Eccentric). Every individual in both groups will be examined before and after the 6-week treatment program.
The handheld dynamometer assessed isometric trunk flexion and extension strength Pain intensity by casual analog scale (VAS). The Trunk Impairment Scale (TIS) evaluates static and dynamic sitting balance and trunk coordination in a seated position.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Giza, Egypt, 12625
- Cairo University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age range 18 to 40 years.
- Relapsing-remitting free for at least 90 days before testing.
Exclusion Criteria:
- Having a neurologic disease other than MS.
- A relapse within 3 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilates
Fifteen patients will receive Pilates exercises
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Pilates based training exercises group will perform Pilates divided into two levels (beginner and intermediate).
Each level will last for six sessions.
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Experimental: eccentric
Fifteen patients will receives eccentric training
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eccentric trunk training exercises group:The course of the intervention period is 12 sessions total, exercises performed for two to three sets with 10 to 15 repetitions each set and 2 min rest between each set
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: At baseline and after 6 week
|
VAS for measuring pain severity
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At baseline and after 6 week
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Function
Time Frame: At baseline and after 6 week
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The Trunk impairment scale (TIS) The static subscale investigates: (1) the ability of the subject to maintain a sitting position with feet supported; (2) the ability to maintain a sitting position while the legs are passively crossed, and (3) the ability to maintain a sitting position when the subject crosses the legs actively.
The dynamic subscale contains items on lateral flexion of the trunk and unilateral lifting of the hip.
To assess the coordination of the trunk, the subject is asked to rotate the upper or lower part of his or her trunk 6 times, initiating the movements either from the shoulder girdle or from the pelvic girdle, respectively.
For each item, a 2-, 3- or 4- point ordinal scale is used.
On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points.
Therefore, TIS ranges between 0 for a minimal performance to 23 for a perfect performance.
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At baseline and after 6 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
back muscle strength
Time Frame: At baseline and after 6 week
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Handheld dynamometer measuring isometric trunk muscle strength
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At baseline and after 6 week
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Karima A Hassan, Cairo University
Publications and helpful links
General Publications
- Duff WRD, Andrushko JW, Renshaw DW, Chilibeck PD, Farthing JP, Danielson J, Evans CD. Impact of Pilates Exercise in Multiple Sclerosis: A Randomized Controlled Trial. Int J MS Care. 2018 Mar-Apr;20(2):92-100. doi: 10.7224/1537-2073.2017-066.
- Demaneuf T, Aitken Z, Karahalios A, Leong TI, De Livera AM, Jelinek GA, Weiland TJ, Marck CH. Effectiveness of Exercise Interventions for Pain Reduction in People With Multiple Sclerosis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2019 Jan;100(1):128-139. doi: 10.1016/j.apmr.2018.08.178. Epub 2018 Sep 19.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PILATES 2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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