NCT03706131

Brief Summary

Taking into consideration the effects of mobilization on muscle tone and balance, it is predicted that this method will have effective results in the treatment of individuals with MS. Therefore, it is thought that grade A and grade B mobilization applications can be used to strengthen the balance control mechanisms of MS individuals and to regulate muscle tone by increasing the proprioceptive input. In this study, it was aimed to investigate the short-term effects of cervical mobilization on balance and spasticity in MS individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
2.5 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

29 days

First QC Date

August 9, 2018

Last Update Submit

May 6, 2021

Conditions

Multiple SclerosisBalance; Distorted

Keywords

multiple sclerosiscervical regionbalancespasticitymobilisation

Outcome Measures

Primary Outcomes (1)

  • Computerized Dynamic Posturography

    balance assessment

    30 minutes

Secondary Outcomes (3)

  • Berg Balance Scale

    7 minutes

  • Range of Motion

    10 minutes

  • Modified Ashworth Scale

    10 minutes

Study Arms (2)

experimental group

EXPERIMENTAL

one session 15 minutes cervical mobilisation and home exercise

Other: cervical mobilisation

control grup

NO INTERVENTION

no intervention

Interventions

cervical mobilisationOTHER

manual therapy

experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Expanded Disability Status Scale (EDSS) score between 2-5,
  • The EDSS Cerebellar System Subscale has a Functional System Score of ˃0,
  • At least one of the hip extender, Gastro-soleus and Quadriceps Femoris muscles has a spasticity of ≤2 according to the Modifiye Ashworth scale (MAS)
  • If the medical condition is stable and there is no drug change in the last month,
  • Vertebro-bacillus test is negative,
  • have no other orthopedic problems to prevent further neurological distress and participation in the study,
  • At least 24 points from the Mini Mental Test,
  • They are designated as volunteers to participate in the study. -

You may not qualify if:

  • Under age 18 and older than 65 years
  • The Expanded Disability Status Scale (EDSS) score is less than 2, higher than 5,
  • The EDSS Cerebellar System Subscale has a Functional System Score of 0,
  • The spasticity values of the hip extender, Gastro-soleus and Quadriceps Femoris muscles are ˃2 according to the Modifiye Ashworth scale (MAS)
  • The cognitive problem is that the Mini Mental Test score is below 24,
  • The existence of cardiovascular, orthopedic, psychological and other problems that may prevent the completion of the assessments,
  • Vertebro-bacillus test is positive,
  • plaque presence of cervical and thoracal region demyelination,
  • Having had an attack within the last 3 months,
  • Botulinum toxin administration in the last 6 months,
  • Has been admitted to the physiotherapy program in the last six months -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Karlberg M, Magnusson M, Malmstrom EM, Melander A, Moritz U. Postural and symptomatic improvement after physiotherapy in patients with dizziness of suspected cervical origin. Arch Phys Med Rehabil. 1996 Sep;77(9):874-82. doi: 10.1016/s0003-9993(96)90273-7.

    PMID: 8822677RESULT

Related Links

MeSH Terms

Conditions

Multiple SclerosisMuscle Spasticity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kadriye armutlu, prof.dr.

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Spasticity evaluations will be done by blind investigator.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 9, 2018

First Posted

October 15, 2018

Study Start

April 1, 2021

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

May 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)