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Effect of Cervical Mobilization on Balance and Plantar Pressure Distribution in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Muscle Spasticity, Pressure Area

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Traditional Rehabilitation for multiple sclerosis
Cervical mobilization for multiple sclerosis
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring cervical region, multiple sclerosis, muscle spasticity, manual therapy, cervical spine, Plantar pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Other

Experimental

Arm Label

Traditional Rehabilitation

Cervical Mobilization

Arm Description

Traditional Rehabilitation program was included strengthening exercises for the muscles needed, balance and coordination exercises according to the individual's level, stretching for the lower limbs in all individuals. Indıvıduals participated in 2 training sessions per week for 4 weeks. Each training session consisted of a 5-minute non-balance coordination exercise, a 30-minute balance and coordination exercise, a 10-minute stretching and strengthing.

Cervical Mobilization program, cervical mobilization techniques were applied to the patients for 30 minutes in addition to the traditional program. Cervical mobilization includes suboccipital relaxing techniques, myofascial muscle relaxing techniques for Levator scapula, trapezius, scalenes muscles. These techniques were applied bilaterally.

Outcomes

Primary Outcome Measures

Change Plantar Pressure Distribution
Pedobarography system was used for plantar pressure analyses. Pedobarography system contains screen, color printer, pressure sensor platform, remote control device, power unit, printer-to-platform and screen-to-platform connections. The maximum and mean pressure in the foot, the percentages of pressure values in the fore and rear of the foot, percentages of the total pressure falling to the foot were evaluated. As higher values mean higher load.
Change Balance
Romberg test (RT) was performed on the patients with eyes closed and feet together. When the participant held it in one place, the test was terminated, oscillations began, or was likely to fall. Romberg test's maximum duration was 120 sec. RT is clinically used for vestibular problems. Sharpened Romberg (SR) was performed on a straight line with one leg behind the other leg, eyes open, leaving the arms sagging and without impairing the balance. Duration stop criteria were defined as the time that took a participant to dislocate the foot, reach the maximal duration of 30 sec, and contact the observer to avoid falling. Individuals' dynamic balance was evaluated with the Functional Reach Test (FRT). Individuals had requested their hands at 90 degrees by keeping the dominant arms' elbow straight on the wall. The test was performed as reaching forward without taking a step and losing the balance on the wall. The metacarpal bone level was marked in the start position and final position

Secondary 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

Full Information

First Posted
September 2, 2020
Last Updated
January 18, 2021
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT04543448
Brief Title
Effect of Cervical Mobilization on Balance and Plantar Pressure Distribution in Multiple Sclerosis
Official Title
Investigation the Effect of Cervical Mobilization on Balance and Plantar Pressure Distribution in Multiple Sclerosis Patients: A Randomized Crossover Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
August 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
MS patients were randomly divided into traditional therapy and traditional therapy + cervical mobilization groups. While muscle strengthening, stretching, balance and coordination exercises were given to the traditional group, cervical mobilization was applied in addition to these in cervical group. Patients received treatments twice a week for 4 weeks. The effect of the applied treatment on the tonus and plantar pressure distribution was analyzed. Treatments were interrupted for 4 weeks and the groups continued with the treatment they did not receive (crossover design). The group that received traditional treatment in the first period completed traditional + cervical mobilization, and the other group with traditional + cervical mobilization traditionally completed the 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. The cervical region is parasympathetic area have common relaxed effect. Thus this part can be benefit to improvement of balance. As improve balance, the plantar pressure distribution of patients may change.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Muscle Spasticity, Pressure Area, Cervical Region Disorder Nos
Keywords
cervical region, multiple sclerosis, muscle spasticity, manual therapy, cervical spine, Plantar pressure

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
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Rehabilitation
Arm Type
Other
Arm Description
Traditional Rehabilitation program was included strengthening exercises for the muscles needed, balance and coordination exercises according to the individual's level, stretching for the lower limbs in all individuals. Indıvıduals participated in 2 training sessions per week for 4 weeks. Each training session consisted of a 5-minute non-balance coordination exercise, a 30-minute balance and coordination exercise, a 10-minute stretching and strengthing.
Arm Title
Cervical Mobilization
Arm Type
Experimental
Arm Description
Cervical Mobilization program, cervical mobilization techniques were applied to the patients for 30 minutes in addition to the traditional program. Cervical mobilization includes suboccipital relaxing techniques, myofascial muscle relaxing techniques for Levator scapula, trapezius, scalenes muscles. These techniques were applied bilaterally.
Intervention Type
Other
Intervention Name(s)
Traditional Rehabilitation for multiple sclerosis
Other Intervention Name(s)
traditional rehabilitation
Intervention Description
Traditional rehabilitation program include strengthening exercises for the muscles needed, balance and coordination exercises according to the individual's level, stretching for the lower limbs.
Intervention Type
Other
Intervention Name(s)
Cervical mobilization for multiple sclerosis
Other Intervention Name(s)
traditional rehabilitation+ cervical mobilization
Intervention Description
Cervical mobilization program include myofascial relaxation techniques and mobilization to cervical spine in addition to traditional program.
Primary Outcome Measure Information:
Title
Change Plantar Pressure Distribution
Description
Pedobarography system was used for plantar pressure analyses. Pedobarography system contains screen, color printer, pressure sensor platform, remote control device, power unit, printer-to-platform and screen-to-platform connections. The maximum and mean pressure in the foot, the percentages of pressure values in the fore and rear of the foot, percentages of the total pressure falling to the foot were evaluated. As higher values mean higher load.
Time Frame
Change from plantar pressure distribution at one month
Title
Change Balance
Description
Romberg test (RT) was performed on the patients with eyes closed and feet together. When the participant held it in one place, the test was terminated, oscillations began, or was likely to fall. Romberg test's maximum duration was 120 sec. RT is clinically used for vestibular problems. Sharpened Romberg (SR) was performed on a straight line with one leg behind the other leg, eyes open, leaving the arms sagging and without impairing the balance. Duration stop criteria were defined as the time that took a participant to dislocate the foot, reach the maximal duration of 30 sec, and contact the observer to avoid falling. Individuals' dynamic balance was evaluated with the Functional Reach Test (FRT). Individuals had requested their hands at 90 degrees by keeping the dominant arms' elbow straight on the wall. The test was performed as reaching forward without taking a step and losing the balance on the wall. The metacarpal bone level was marked in the start position and final position
Time Frame
Change from plantar pressure distribution at one month
Secondary 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

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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KEZBAN BAYRAMLAR, Prof. Dr.
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Study Director
Facility Information:
Facility Name
Hasan Kalyoncu University
City
Gaziantep
Country
Turkey

12. IPD Sharing Statement

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Effect of Cervical Mobilization on Balance and Plantar Pressure Distribution in Multiple Sclerosis

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