Clinical trial NCT04548297: Clinical Factors Associated With Position Sense in Patients With Multiple Sclerosis
Official title: Clinical Factors Associated With Position Sense in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
sensation
fatigue
physical activity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ambulatory sample

Brief summary: Sensory impairment is an important problem for patients with Multiple Sclerosis (MS). Although there is no complete loss of sensation in patients, 80% of patients have a significant sensory impairment. The sensory system plays an important role in providing the feedback required to perform motor tasks. Cutaneous sensation, especially in the sole of the foot, is very important in maintaining balance and gait. There are studies showing decreased foot sole sensation in MS patients. Another sensation that is important during motor tasks is the proprioceptive sensation.

The aim of this study is to examine the relationship between the sensation of foot sole and joint position, clinical features, attention, fatigue, body awareness and physical activity level in patients with MS.

Detailed description: Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The sensation of foot sole, joint position sensation, attention, fatigue, body awareness, and physical activity level will be evaluated.

The investigators will use t-tests to compare for quantitative variables and chi-square for the categorical variables between groups. In addition, the investigators will examine the correlations between the sensation of the foot sole, joint position sensation, attention, fatigue, body awareness, and physical activity level using Pearson bivariate correlations.

Eligibility criteria: Inclusion Criteria:

* 18-65 years of age
* Having a diagnosis of "Multiple Sclerosis"
* Relapse free in the last 3 mounts
* Ambulatory status (Expanded Disability Status Scale score ≤ 6 )
* No diagnosis of depression

Exclusion Criteria:

* Any cardiovascular, orthopedic, visual, and hearing problems that may affect the results of the research

Primary outcomes:
measure: Light touch-pressure sensation
timeFrame: 10 minutes
measure: Vibration sensation
timeFrame: 10 minutes]
measure: position sensation of knee joint
timeFrame: 5 minutes
measure: Knee proprioception
timeFrame: 10 minutes
Secondary outcomes:
measure: Fatigue Severity
timeFrame: 5 minutes
measure: attention
timeFrame: 5 minutes
measure: Physical Activity
timeFrame: 10 minutes
measure: Body Awareness
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Cagla Ozkul
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanders EA, Arts RJ. Paraesthesiae in multiple sclerosis. J Neurol Sci. 1986 Jul;74(2-3):297-305. doi: 10.1016/0022-510x(86)90115-2.
citation: Merchut MP, Gruener G. Quantitative sensory threshold testing in patients with multiple sclerosis. Electromyogr Clin Neurophysiol. 1993 Mar;33(2):119-24.
citation: Kars HJ, Hijmans JM, Geertzen JH, Zijlstra W. The effect of reduced somatosensation on standing balance: a systematic review. J Diabetes Sci Technol. 2009 Jul 1;3(4):931-43. doi: 10.1177/193229680900300441.
citation: Eils E, Behrens S, Mers O, Thorwesten L, Volker K, Rosenbaum D. Reduced plantar sensation causes a cautious walking pattern. Gait Posture. 2004 Aug;20(1):54-60. doi: 10.1016/S0966-6362(03)00095-X.