- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04201691
Effect of Manuel Therapy on Tonus, Proprioseption and Balance in Multiple Sclerosis
August 9, 2021 updated by: Tuba Maden
The Effect of Cervical Mobilization on Tonus, Position Sense and Balance in Multiple Sclerosis Patients
This study is investigates the effect of cervical mobilization on tonus, position sense and balance in patient with multiple sclerosis.
Half of participants will received classic rehabilitation program, while the other half will received servical mobilization in addition to classic rehabilitation program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cervical region is rich in terms of muscle spindle and reseptors.
When this region is touched by physiotherapists, muscle spindles is activited.
Thus position sense of joint and balance is developed.
Besides, cervical region is parasympathetic area have common relaxed effect.
Thus this part can be benefit to regulation of tonus.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gaziantep, Turkey
- Hasan Kalyoncu University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Expanded Disability Status Scale (EDSS) score was between 2-5,
- According to the modified Ashworth Scale, spasticity is between 1 and 3,
- EDSS Cerebellar System Sub-Scale, Functional System Score ˃1,
- medical condition is stable and no medication changes were made in the last month,
- Vertebro-basillar test negative,
- Not have any other neurological disorder and orthopedic problem to prevent participation in this study
- A score of at least 24 from the Mini Mental Test,
Exclusion Criteria:
- presence of psychiatric or severe cognitive dysfunction,
- pregnancy,
- Having a neurological disease other than MS,
- having had an attack in the last 3 months,
- Botulinum toxin application within the last 6 months,
- participating in physiotherapy program in the last 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: conventional group
Conventional group is received conventional rehabilitation program.
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The intervention is conventional rehabilitation that included streching, balance and coordination training.
The intervention is applied to participants, manually.
Other Names:
Another intervention is manuel therapy that included gliding technics, rotational technics at cervical region.
(in addition to classic rehabilitation).
The intervention is applied to participants, manually.
Other Names:
|
Experimental: mobilization group
Mobilization group is received cervical mobilization in addition to conventional rehabilitation program.
|
The intervention is conventional rehabilitation that included streching, balance and coordination training.
The intervention is applied to participants, manually.
Other Names:
Another intervention is manuel therapy that included gliding technics, rotational technics at cervical region.
(in addition to classic rehabilitation).
The intervention is applied to participants, manually.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change Modified ashworth scale
Time Frame: Change from Modified ashworth scale at one month
|
Modified Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.
The minimum value is 1 and the maximum value is 4. Whether higher scores mean a worse outcome.
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Change from Modified ashworth scale at one month
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Change Berg Balance Test
Time Frame: Change from Berg Balance Test at one month
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The scale rates performance from 0 (cannot perform) to 4 (normal performance) on 14 items.
The items explore the ability to sit, stand, lean, turn and maintain the upright position on one leg.
A cut-off score of 44 was established as a criterion to identify MS subjects with a high risk of fall based on results in the literature.
The minumum value is 0, the maximum value is 56.
Whether higher scores mean a better outcome.
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Change from Berg Balance Test at one month
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Change Dynamic Gait Index
Time Frame: Change from Dynamic Gait Index at one month
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The scale measures the mobility function and the dynamic balance.
The eight tasks of this scale include walking, walking with head turns, pivoting, walking over objects, walking around objects and going up stairs.
The performance is rated on a 4-point scale.
A score of 19 or less has been shown to be related to self-reported falls in people with vestibular disorders.
The minimum value is 8, the maximum value is 24.
Whether higher scores mean a better outcome.
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Change from Dynamic Gait Index at one month
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MyotonPRO
Time Frame: 30 days
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The MyotonPRO is a small, noninvasive hand-held apparatus that provides objective measurements of mechanical muscle properties expressed on a continuous scale.
After the device probe is positioned on the skin surface above the muscle being measured, and thereby slightly compressing subcutaneous superficial tissue, it exerts a light quick released mechanical impulse.
The subsequent dampened oscillation of the muscle is recorded by an accelerometer and numeric values of muscle parameters are calculated, representing the muscle tone, and biomechanical properties.
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30 days
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Change The timed 25-foot walk
Time Frame: Change from The timed 25-foot walk at one month
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The T25-FW is easy to administer, is useful for a range of walking disabilities, and correlates well with other measures of walking ability.
The shortening of the time indicate that the patient recovered.
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Change from The timed 25-foot walk at one month
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Change Functional Reach Test
Time Frame: Change from Functional Reach Test at one month
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A yardstick was mounted at the height of the patient's acromion.
The patient was asked to stretch their arm parallel to the yardstick with fist closed.
Then the patient was asked to lean forward as far a possible without taking a step.
The new position of the end of the metacarpal bone was marked and the difference to the starting position was calculated.
The mean value of three tries was recorded.
The Functional Reach Test is a simple measurement of standing balance.
Streched distance is the more longer the more better.
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Change from Functional Reach Test at one month
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Change Sharpened Romberg
Time Frame: Change from Sharpened Romberg at one month
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Participants were asked to remain standing, on a straight line with one leg behind the other leg, leaving the arms sagging and without impairing the balance.
Duration stop criteria were defined as the time it took a participant to dislocate the foot, reach the maximal duration of 30 sec, and contact the observer to avoid falling.
Higher scores mean a better outcome.
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Change from Sharpened Romberg at one month
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Change Single Leg Stance Test- Right
Time Frame: Change from Single Leg Stance Test- Right at one month
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Duration of standing was measured in participants standing with dangling arms.
Maximal duration of test is 30 sec.
Higher scores mean a better outcome.
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Change from Single Leg Stance Test- Right at one month
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Change Single Leg Stance Test- Left
Time Frame: Change from Single Leg Stance Test- Left at one month
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Duration of standing was measured in participants standing with dangling arms.
Maximal duration of test is 30 sec.
Higher scores mean a better outcome.
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Change from Single Leg Stance Test- Left at one month
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Change Joint of position sense
Time Frame: Change from Joint of position sense at one month
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Position sense was evaluated with Baseline digital goniometer.
Extremity of participant is positioned to target angle and hold it there three seconds before returning to starting position.
After returning to the starting position, participants attempted to repeat the previously attained angle.
The measurements were repeated three times on both extremities (non-dominant and dominant) with a 30-second rest period separating trials.
tests are carried out closed eyes for shoulder, ankle, knee.
The angular difference is the more smaller the more better.
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Change from Joint of position sense at one month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 7, 2020
Primary Completion (Actual)
November 2, 2020
Study Completion (Actual)
December 30, 2020
Study Registration Dates
First Submitted
December 12, 2019
First Submitted That Met QC Criteria
December 14, 2019
First Posted (Actual)
December 17, 2019
Study Record Updates
Last Update Posted (Actual)
August 10, 2021
Last Update Submitted That Met QC Criteria
August 9, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/106
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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