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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Gaziantep, Turkey
        • Hasan Kalyoncu University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: conventional group
Conventional group is received conventional rehabilitation program.
Other: classic rehabilitation
The intervention is conventional rehabilitation that included streching, balance and coordination training. The intervention is applied to participants, manually.
Other Names:
  • conventional rehabilitation
Other: 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.
Other Names:
  • experimental rehabilitation
Experimental: mobilization group
Mobilization group is received cervical mobilization in addition to conventional rehabilitation program.
Other: classic rehabilitation
The intervention is conventional rehabilitation that included streching, balance and coordination training. The intervention is applied to participants, manually.
Other Names:
  • conventional rehabilitation
Other: 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.
Other Names:
  • experimental rehabilitation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Change from Modified ashworth scale at one month
Change Berg Balance Test
Time Frame: Change from Berg Balance Test at one month
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
Change Dynamic Gait Index
Time Frame: Change from Dynamic Gait Index at one month
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
MyotonPRO
Time Frame: 30 days
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
Change The timed 25-foot walk
Time Frame: Change from The timed 25-foot walk at one month
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
Change Functional Reach Test
Time Frame: Change from Functional Reach Test at one month
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
Change Sharpened Romberg
Time Frame: Change from Sharpened Romberg at one month
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
Change Single Leg Stance Test- Right
Time Frame: Change from Single Leg Stance Test- Right at one month
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
Change Single Leg Stance Test- Left
Time Frame: Change from Single Leg Stance Test- Left at one month
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
Change Joint of position sense
Time Frame: Change from Joint of position sense at one month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tuba Maden

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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