Clinical trial NCT04543448: Effect of Cervical Mobilization on Balance and Plantar Pressure Distribution in Multiple Sclerosis
Official title: Investigation the Effect of Cervical Mobilization on Balance and Plantar Pressure Distribution in Multiple Sclerosis Patients: A Randomized Crossover Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Muscle Spasticity
Pressure Area
Cervical Region Disorder Nos
Keywords: cervical region
multiple sclerosis
muscle spasticity
manual therapy
cervical spine
Plantar pressure
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change Plantar Pressure Distribution
timeFrame: Change from plantar pressure distribution at one month
measure: Change Balance
timeFrame: Change from plantar pressure distribution at one month
Secondary outcomes:
measure: Change Modified ashworth scale
timeFrame: Change from Modified ashworth scale at one month
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
affiliation: Hasan Kalyoncu University
name: KEZBAN BAYRAMLAR, Prof. Dr.
role: STUDY_DIRECTOR
References: