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Completed

NCT Number: NCT04543448

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cervical Region Disorder Nos Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Pressure Area Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: traditional rehabilitation+ cervical mobilization

Primary outcomes

  1. Change Plantar Pressure Distribution

    Time frame: Change from plantar pressure distribution at one month

    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.

  2. Change Balance

    Time frame: Change from plantar pressure distribution at one month

    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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2020
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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