Back to resultsEffect of Manuel Therapy on Tonus, Proprioseption and Balance in Multiple Sclerosis
Primary Purpose
Postural Balance, Multiple Sclerosis, Cervical Region Disorder Nos
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
classic rehabilitation
classic rehabilitation+mobilization
Sponsored by
About this trial
This is an interventional treatment trial for Postural Balance
Eligibility Criteria
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
Sites / Locations
- Hasan Kalyoncu University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
conventional group
mobilization group
Arm Description
Conventional group is received conventional rehabilitation program.
Mobilization group is received cervical mobilization in addition to conventional rehabilitation program.
Outcomes
Primary Outcome Measures
Change Modified ashworth scale
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.
Change Berg Balance Test
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.
Change Dynamic Gait Index
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.
MyotonPRO
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.
Change The timed 25-foot walk
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.
Change Functional Reach Test
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.
Change Sharpened Romberg
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.
Change Single Leg Stance Test- Right
Duration of standing was measured in participants standing with dangling arms. Maximal duration of test is 30 sec. Higher scores mean a better outcome.
Change Single Leg Stance Test- Left
Duration of standing was measured in participants standing with dangling arms. Maximal duration of test is 30 sec. Higher scores mean a better outcome.
Change Joint of position sense
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04201691
Brief Title
Effect of Manuel Therapy on Tonus, Proprioseption and Balance in Multiple Sclerosis
Official Title
The Effect of Cervical Mobilization on Tonus, Position Sense and Balance in Multiple Sclerosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
November 2, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tuba Maden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Balance, Multiple Sclerosis, Cervical Region Disorder Nos, Muscle Tonus, Proprioception
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants are grouped randomly. First group and second group are applied different rehabilitation programs. Both of group is rest four weeks. Than second group is applied first group's rehabilitation program and first group is applied second group's rehabilitation program.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional group
Arm Type
Experimental
Arm Description
Conventional group is received conventional rehabilitation program.
Arm Title
mobilization group
Arm Type
Experimental
Arm Description
Mobilization group is received cervical mobilization in addition to conventional rehabilitation program.
Intervention Type
Other
Intervention Name(s)
classic rehabilitation
Other Intervention Name(s)
conventional rehabilitation
Intervention Description
The intervention is conventional rehabilitation that included streching, balance and coordination training. The intervention is applied to participants, manually.
Intervention Type
Other
Intervention Name(s)
classic rehabilitation+mobilization
Other Intervention Name(s)
experimental rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change Modified ashworth scale
Description
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.
Time Frame
Change from Modified ashworth scale at one month
Title
Change Berg Balance Test
Description
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.
Time Frame
Change from Berg Balance Test at one month
Title
Change Dynamic Gait Index
Description
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.
Time Frame
Change from Dynamic Gait Index at one month
Title
MyotonPRO
Description
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.
Time Frame
30 days
Title
Change The timed 25-foot walk
Description
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.
Time Frame
Change from The timed 25-foot walk at one month
Title
Change Functional Reach Test
Description
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.
Time Frame
Change from Functional Reach Test at one month
Title
Change Sharpened Romberg
Description
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.
Time Frame
Change from Sharpened Romberg at one month
Title
Change Single Leg Stance Test- Right
Description
Duration of standing was measured in participants standing with dangling arms. Maximal duration of test is 30 sec. Higher scores mean a better outcome.
Time Frame
Change from Single Leg Stance Test- Right at one month
Title
Change Single Leg Stance Test- Left
Description
Duration of standing was measured in participants standing with dangling arms. Maximal duration of test is 30 sec. Higher scores mean a better outcome.
Time Frame
Change from Single Leg Stance Test- Left at one month
Title
Change Joint of position sense
Description
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.
Time Frame
Change from Joint of position sense at one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hasan Kalyoncu University
City
Gaziantep
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Effect of Manuel Therapy on Tonus, Proprioseption and Balance in Multiple Sclerosis
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