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

Investigation the Effect of Cervical Mobilization on Balance and Plantar Pressure Distribution in Multiple Sclerosis Patients: A Randomized Crossover Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Muscle Spasticity; Cervical Region Disorder Nos; Pressure Area
• Intervention / Treatment: Other: Traditional Rehabilitation for multiple sclerosis; Other: Cervical mobilization for multiple sclerosis

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Gaziantep, Turkey
    • Hasan Kalyoncu University

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Traditional Rehabilitation; 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.	Other: Traditional Rehabilitation for multiple sclerosis; 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.; Other Names: traditional rehabilitation
EXPERIMENTAL: Cervical Mobilization; 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.	Other: Cervical mobilization for multiple sclerosis; Cervical mobilization program include myofascial relaxation techniques and mobilization to cervical spine in addition to traditional program.; Other Names: traditional rehabilitation+ cervical mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 from plantar pressure distribution at one month
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	Change from plantar pressure distribution at one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hasan Kalyoncu University
• Investigators: Study Director: KEZBAN BAYRAMLAR, Prof. Dr., Hasan Kalyoncu University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2019
• Primary Completion (ACTUAL): May 31, 2020
• Study Completion (ACTUAL): August 20, 2020

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (ACTUAL): September 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: multiple sclerosis; manual therapy; muscle spasticity; cervical spine; Plantar pressure; cervical region
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Multiple Sclerosis; Sclerosis; Muscle Spasticity
• Other Study ID Numbers: 2019/0107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No