Skip to main content
Clinical Trials/NCT04543448
NCT04543448
Completed
Not Applicable

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

Hasan Kalyoncu University1 site in 1 country12 target enrollmentOctober 2, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Hasan Kalyoncu University
Enrollment
12
Locations
1
Primary Endpoint
Change Balance
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2, 2019
End Date
August 20, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Hasan Kalyoncu University
Responsible Party
Principal Investigator
Principal Investigator

Tuba Maden

Principal Investigator, clinical research

Hasan Kalyoncu University

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

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

  • Change Modified ashworth scale(Change from Modified ashworth scale at one month)

Study Sites (1)

Loading locations...

Similar Trials