Multiple Sclerosis Clinical Trial
Official title:
The Effect of Cervical Mobilization on Balance and Spasticity in Multiple Sclerosis Individuals
NCT number | NCT03706131 |
Other study ID # | KA-17087 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2021 |
Est. completion date | April 30, 2021 |
Verified date | May 2021 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | April 30, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: Between the ages of 18-65 - 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. - Exclusion Criteria: - 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 - |
Country | Name | City | State |
---|---|---|---|
Turkey | Hacettepe University | Ankara |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
Karlberg M, Magnusson M, Malmström 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Computerized Dynamic Posturography | balance assessment | 30 minutes | |
Secondary | Berg Balance Scale | The BBS is a 14-item scale that was designed to measure balance in the elderly population in a clinical setting. It has also been used to assess postural balance in people with a history of stroke and traumatic brain injury. The BBS consists of 14 different tests examining individuals' ability to sit, stand, reach, maintain single-leg stance, and turn. It rates performance on a scale from 0 (cannot perform task) to 4 (normal performance on task). In the elderly population, it has been found to be a good predictor of falling, with good validity and reliability.The total possible score ranges from 0 to 56; a score of 45 or below indicates an increased risk of falling. | 7 minutes | |
Secondary | Range of Motion | Goniometric measurements are used by physical therapists to quantify baseline limitations of motion, decide on appro- priate therapeutic interventions, and document the effectiveness of these interventions. This assessment is used for spasticity evaluation. | 10 minutes | |
Secondary | Modified Ashworth Scale | The Modified Ashworth Scale (MAS) measures resistance during passive soft-tissue stretching. It is a quick and easy measure that can help assess the efficacy of treatment.
Scoring 0 = Normal tone, no increase in tone 1 = Slight increase in muscle tone, manifested by a catch and release or minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension 1+ = Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2= More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3= Considerable increase in muscle tone, passive movement difficult 4=Affected part(s) rigid in flexion or extension. |
10 minutes |
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