Multiple Sclerosis Clinical Trial
Official title:
The Effects of Extremity and "Core" Muscles Strength on Walking and Sit-to-Stand Performance in Patients With Multiple Sclerosis
NCT number | NCT03597451 |
Other study ID # | 435 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 13, 2018 |
Est. completion date | March 6, 2020 |
Verified date | April 2020 |
Source | Gazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Muscle weakness, which is one of the most common symptoms in patients with MS, limits the
activities of daily life activities of patients by causing balance and gait disturbance.
Lower extremity muscle strengths of MS patients are reported to be weaker than healthy
individuals. Broekmans et al. showed that the weakness of the knee flexor and extensor
muscles in patients with MS caused a decrease in walking distance and they are important
determinants of walking capacity.
The effects of the endurance and strength of core muscles, as well as the extremity muscles,
are important on physical performance. The weakness of the extremities and core muscles in MS
patients also affects the sit-to-stand performance negatively as well as a decrease in
walking speed and capacity.
In this study, it was aimed to investigate the effects of extremity and core muscle strength
on walking and sitting-up performance of MS patients.
Status | Completed |
Enrollment | 87 |
Est. completion date | March 6, 2020 |
Est. primary completion date | February 28, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Participants who 18-65 years of age - MS patients who are ambulatory (Expanded Disability Status Scale score = 5,5 ) in a stable phase of the disease, without relapses in the last 3 month. Exclusion Criteria: - Participants who have orthopedic, vision, hearing, or perception problems |
Country | Name | City | State |
---|---|---|---|
Turkey | Gazi University | Ankara |
Lead Sponsor | Collaborator |
---|---|
Gazi University |
Turkey,
Bliss LS, Teeple P. Core stability: the centerpiece of any training program. Curr Sports Med Rep. 2005 Jun;4(3):179-83. Review. — View Citation
Broekmans T, Gijbels D, Eijnde BO, Alders G, Lamers I, Roelants M, Feys P. The relationship between upper leg muscle strength and walking capacity in persons with multiple sclerosis. Mult Scler. 2013 Jan;19(1):112-9. doi: 10.1177/1352458512444497. Epub 2012 May 4. — View Citation
Fry DK, Huang M, Rodda BJ. Core muscle strength and endurance measures in ambulatory persons with multiple sclerosis: validity and reliability. Int J Rehabil Res. 2015 Sep;38(3):206-12. doi: 10.1097/MRR.0000000000000109. — View Citation
Ketelhut NB, Kindred JH, Manago MM, Hebert JR, Rudroff T. Core muscle characteristics during walking of patients with multiple sclerosis. J Rehabil Res Dev. 2015;52(6):713-24. doi: 10.1682/JRRD.2015.01.0006. — View Citation
Yahia A, Ghroubi S, Mhiri C, Elleuch MH. Relationship between muscular strength, gait and postural parameters in multiple sclerosis. Ann Phys Rehabil Med. 2011 May;54(3):144-55. doi: 10.1016/j.rehab.2011.02.004. Epub 2011 Mar 9. English, French. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | strength of extremity muscles | The isometric strength of lower extremity muscles will be assessed respectively using a hand-held dynamometer (Baseline®, White Plains, New York, USA). | baseline | |
Secondary | 6 minutes walking test | The Six-Minute Walking Test (6MWT) was performed to determine walking capacity. | baseline | |
Secondary | timed up and go test | Timed up and go test measures the time taken in seconds to arise from a standard chair, walk 3 m, turn through 180 degrees, walk back, and sit down again. | baseline | |
Secondary | sit-to-stand test | In this test, the participants will stand up from and sit down on 43 cm high armless chair as quickly as possible 5 times. | baseline | |
Secondary | Side Bridge Test (core muscles endurance) | The subjects were asked to lay on their left or right sides and to extend their legs fully. Then The subjects are asked to create a straight line with their body by lifting their hip from the floor.The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions. | baseline | |
Secondary | Modified Biering-Sorensen test (core muscles endurance) | In this test, the subjects are asked to lie down on a workout bench, aligning their anterior superior iliac spine with the edge of the bench, which allowed the upper body to be planked out over the edge. The subjects are asked to fold their arms on their chest and to put their hands on their shoulders. The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions. | baseline | |
Secondary | Trunk Flexion Test (core muscles endurance) | This test is initiated when the subjects are in a sit-up position with their back resting against a wedge that was angled 55° from the floor. The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions. | baseline | |
Secondary | Prone bridge test (core muscles endurance) | In this test, the subjects put their elbows on the ground as the starting position and open their feet about the width of their hips while keeping their body straight as they are required not to arch or bow. The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions. | baseline |
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