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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05377476
Other study ID # 2022-5
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date June 1, 2024

Study information

Verified date January 2023
Source Hacettepe University
Contact Melike Sumeyye Ozen, M.Sc.
Phone 506 153 06 06
Email mcengiz@bandirma.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It was planned to examine the effects of motor imagery and action observation training applied in addition to standard rehabilitation in individuals with Multiple Sclerosis on walking, fatigue, trunk control and muscle oxygenation.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Being between the ages of 18-65 - Having a definite diagnosis of MS - Expanded Disability Status Scale (EDSS) score of 4.0 and below (it is determined routinely by the physician during the examination) - Not having an attack in the last 3 months Exclusion Criteria: - Having another musculoskeletal, cardiovascular, pulmonary, metabolic, or neurological disease severe enough to preclude participation in the study. - Having severe vision and hearing problems - Presence of severe cognitive impairment detected by the physician at a level that prevents the tests from being performed.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Motor Imagery training
Individuals included in this group will receive 20 minutes of motor imagery training in addition to 40 minutes of standard rehabilitation.
Action Observation training
Individuals included in this group will receive 20 minutes of action observation training in addition to 40 minutes of standard rehabilitation.
standard rehabilitation
40 minutes of standard rehabilitation.

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (2)

Lead Sponsor Collaborator
Hacettepe University Bandirma Onyedi Eylül University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 6 Min Walking Test It will be used to measure walking capacity. Before the test is applied, necessary information will be given to the individuals and they will be asked to walk as fast as possible for 6 minutes on the 30-meter track. 6 week
Primary Timed Up and Go Test It will be used to assess the functional mobility of individuals. Individuals will be asked to stand up without support from the chair they are sitting in, and to return from the designated area after walking a distance of 3 meters and sit back on the chair without support. 6 week
Primary Dynamic Gait Index It is a scale that evaluates gait balance in MS patients. It examines the balance in completely different walking situations, including daily life activities such as turning the head while walking, taking a step over an obstacle, climbing and descending stairs. 6 week
Primary Multiple Sclerosis Walking Scale-12 It is a scale used to measure walking capacity. 6 week
Primary RehaGait® (Hasomed, Magdeburg, Germany) Gait Analysis The device gives about the time-distance characteristics and kinematic data of the gait. 6 week
Primary Fatigue Severity Scale It is a scale that evaluates the extent to which fatigue affects the daily functions of MS patients. 6 week
Primary Trunk Impairment Scale It is used to evaluate trunk control. 6 week
Primary Assessment of the Endurance of Core Muscles The McGill protocol will be applied to assess the endurance of the core muscles. This protocol consists of a combination of 4 tests; modified Biering-Sorenson test, trunk flexor endurance test, right and left lateral bridge (lateral plank) tests. 6 week
Primary Assessment of the Strength of Core Muscles It will be evaluated with "Sit-ups" and Modified "Push-ups" tests. 6 week
Secondary Kinesthetic and Visual Imagery Questionnaire It is a tool used to assess individuals' imagery levels. 6 week
Secondary Movement Imagery Questionnaire-3 It is a tool used to assess individuals' imagery levels. 6 week
Secondary Mental Stopwatch Mental stopwatch is a method that enables the objective measurement of motor imagery by examining the time difference between the physical execution of the movement (Movement Execution Time, MET) and the mental visualization of the same movement (Movement Imagery Time, MIT). 6 week
Secondary Measurement of Muscle Oxygenation It will be measured over the Quadriceps muscle with the MOXY Monitor Device (saturation, Hb values). The Moxy muscle oxygen monitor is a lightweight (42 g) and small (dimensions: 61 × 44 × 21 mm) device that measures regional blood flow and oxygenation by placing it on the skin non-invasively with near infrared spectroscopy (NIRS). 6 week
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