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

NCT04543448 | Completed

• 1 other identifier: 2019/0107
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Muscle Spasticity; Pressure Area; Cervical Region Disorder Nos

Keywords

cervical region; multiple sclerosis; muscle spasticity; manual therapy; cervical spine; Plantar pressure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change Modified ashworth scale

  Change from Modified ashworth scale at one month

Study Arms (2)

Traditional Rehabilitation

OTHER

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

Cervical Mobilization

EXPERIMENTAL

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

Interventions

Traditional Rehabilitation for multiple sclerosis OTHER

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.

Also known as: traditional rehabilitation

Traditional Rehabilitation

Cervical mobilization for multiple sclerosis OTHER

Cervical mobilization program include myofascial relaxation techniques and mobilization to cervical spine in addition to traditional program.

Also known as: traditional rehabilitation+ cervical mobilization

Cervical Mobilization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• KEZBAN BAYRAMLAR, Prof. Dr.

  Hasan Kalyoncu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, clinical research

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 10, 2020
• Study Start: October 2, 2019
• Primary Completion: May 31, 2020
• Study Completion: August 20, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

TU (1)