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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04543448
• Other study ID #: 2019/0107
• Status: Completed
• Phase: N/A
• Start date: October 2, 2019
• Est. completion date: August 20, 2020

Study information

• Verified date: January 2021
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 20, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• Cervical mobilization for multiple sclerosis
Cervical mobilization program include myofascial relaxation techniques and mobilization to cervical spine in addition to traditional program.

Locations

Country	Name	City	State
Turkey	Hasan Kalyoncu University	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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