Effect of Manuel Therapy on Tonus, Proprioseption and Balance in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

The Effect of Cervical Mobilization on Tonus, Position Sense and Balance in Multiple Sclerosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04201691
• Other study ID #: 2019/106
• Status: Completed
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2021
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 30, 2020
• Est. primary completion date: November 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Region Disorder Nos
• Multiple Sclerosis
• Muscle Tonus
• Postural Balance
• Proprioception
• Sclerosis

Intervention

Other:
• classic rehabilitation
The intervention is conventional rehabilitation that included streching, balance and coordination training. The intervention is applied to participants, manually.
• classic rehabilitation+mobilization
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.

Locations

Country	Name	City	State
Turkey	Hasan Kalyoncu University	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Tuba Maden

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 from Modified ashworth scale at one month
Primary	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 from Berg Balance Test at one month
Primary	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.	Change from Dynamic Gait Index at one month
Primary	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.	30 days
Primary	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 from The timed 25-foot walk at one month
Primary	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 from Functional Reach Test at one month
Primary	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 from Sharpened Romberg at one month
Primary	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 from Single Leg Stance Test- Right at one month
Primary	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 from Single Leg Stance Test- Left at one month
Primary	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.	Change from Joint of position sense at one month