KITAMS: Kinesio Tape and Physical Function in Persons With Multiples Sclerosis — KITAMS  

Multiple Sclerosis Clinical Trial

Official title: KITAMS: Kinesio Tape and Physical Function in Persons With Multiples Sclerosis

Status Recruiting

Clinical Trial Summary

Multiple sclerosis (MS) is a disease that causes damage within the central nervous system and results in deficits of body functions. The investigators propose a pilot randomized controlled trial examining the acute effect of kinesio tape application in various body segments on balance, mobility, physical functioning, and pain in persons with MS (pwMS) aged 18 to 55 years old. The investigators will objectively assess balance using a force platform and mobility and physical functioning will be assessed using standardized tests (i.e., Timed Up and Go, Timed 25-foot Walk, 6-minute Step Test, Six Spot Step Test). The trial will recruit 24 pwMS aged 18 to 55 years with mild-to-moderate MS-related disability who will be randomized into intervention (Kinesio Tape) or control conditions (Sham/Inflexible Tape). Participants will complete assessments before and after tape application. This pilot trial will inform future research interventions aiming to use the approach in different situations with pwMS (e.g., exercise).

Clinical Trial Description

Research Plan Participants The investigators will recruit and enroll 24 pwMS (12 per group) aged 18-55 years. This sample size is appropriate for pilot trials, and was not based on power analysis. The number of 12 per group is justified based on feasibility, gains in the precision about the mean and variance, and regulatory consideration. Related to gains in the precision, the gains are less pronounced after 12 participants. Recruitment will occur though advertisements in local newspapers (100-mile radius around Illinois campus) and posts on the Greater Illinois chapter of the National Multiple Sclerosis Society (NMSS) website. The investigators will further recruit using our participant's database that includes pwMS 40 years of age and older. The 24 persons will be randomly assigned in equal ratios through concealed allocation into either the intervention (i.e., Kinesio Tape - KTG; n=12) or control (i.e., Sham Tape - STG; n=12) conditions. The inclusion criteria are: clinically definitive diagnosis of MS; age between 18 and 55 years; relapse-free for the past 30 days and; ability to walk with or without assistive device (i.e., cane, but not walker/rollator). Participants further must be willing to complete in-person assessments in a university research setting. The investigators will exclude those who use wheelchair, crutches and walker or who have moderate cognitive impairment based on the modified Telephone Interview for Cognitive Status (i.e., moderate cognitive impairment, ≤ 12 points). Main Outcomes Balance. Balance will be objectively measured using a force platform (AccuSway, AMTI, Newton, MA, USA) which will be used to calculate the coordinates of the center of pressure (COP) during the standing test using three orthogonal forces and moments. Signals from the force plate will be sampled at 100HZ. Data analysis will then be performed using specific programs developed in MATLAB (Mathworks, Natick, MA, USA). Four classical time domain posturographic parameters will be calculated from the COP co-ordinates: mean deviation along the anterior-posterior (X) and medio-lateral (Y) axes, mean COP velocity along the anterior-posterior (VCOPX) and medio-lateral (VCOPY) axes. Participants will perform a total of four trials (i.e., two with eyes open and two with eyes closed) where they will be asked to stand on the force plate and maintain balance. The force plate will be set up 1.5 meters away from the wall. In the eyes open condition participants will be asked to focus at a dark disc (5cm in diameter) on the wall at the subject's eye level. Each trial will last one minute and participants will be given two minutes rest between trials. The order of the trial condition (eyes open or closed) will be randomized to prevent any order effect. The Timed and up and Go test (TUG) will be used as a measure of functional mobility. The primary outcome of the TUG test is the total time (in seconds) taken to complete the test. The test will be set up on the basis of standardized descriptions that have been previously reported. Participants will be instructed to complete the course as safely and quickly as possible by standing up (without the help of hands), walking toward and around a cone/mark on the floor (approx. 10 feet), walking back to the chair, and then sitting down. If needed, participants will be allowed to use assistive devices while performing the task. Participants will be given 2 trials to complete the TUG test, and the average time across the 2 trials will be computed as the final score. The Timed 25-foot Walk test (T25FW) will be used as a measure of walking speed. The primary outcome of the T25FW test is the total time (in seconds) taken to complete the test. Participants will be directed to one end of a clearly marked 25-foot course and will be instructed to walk 25 feet as quickly as possible, but within the limits of their safety. The time is calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. If needed, participants may use assistive devices when performing the task. Participants will be given 2 trials to complete the T25FW test and the final score will be the average of the 2 completed trials. The Six-minute Walking test (6MW) will be used as a measure of walking endurance. The primary outcome is the distance traveled at the end of 6 minutes with the use of a measuring wheel. The course is set up in a straight and clean hallway with at least 100-feet. Participants will be instructed to walk as quickly and safely as possible for 6 minutes making laps within 2 cones places 30 meters apart from each other. Participants will be allowed to use an assistive device if necessary and to rest when necessary. During the test participants will be followed by a second researcher who will walk to one side close enough for safety purposes. Only one trial is deemed to be appropriate and also helps avoiding fatigue. The Six-spot Step test (SSST) will be used as a measure of lower-body coordination. The primary outcome of the SSST is the mean of the 4 trials in seconds. Participants complete the course as quickly as possible, while kicking the cones off of their labeled position with one foot, alternating between medial and lateral sides of the foot. Each participant completed the SSST four times: twice using their dominant foot, and twice using their non-dominant foot to kick the cones off of their demarcated position. Experiment Intervention Condition Participants allocated into the Kinesio Tape Group (KTG) will receive a single time application of the kinesio tape flexible tape (Kinesio® Tex, Albuquerque, NM, USA) in the upper-body (i.e., back part of the trunk) and in the lower-body (i.e., legs and ankle) according to standardized procedures regarding tape application and participant skin preparation (https://kinesiotaping.com/how-to/). The tape is latex-free and wearable for weeks without causing skin irritation (i.e., hypoallergenic); and safe for populations ranging from pediatric to geriatric. The tape will be applied by a physical therapist with experience in tape application. Tape application will be conducted in a private room with complete structure for the procedure. Control Condition Participants allocated into the Sham Tape Group (STG) will receive a single time application of an inflexible tape (i.e., sham tape) in the same body segments as the intervention condition and applied by an experienced physical therapist. Tape application will be conducted in a private room with complete structure for the procedure. Procedure Recruitment ads/flyers will be created and posted. The study will be described as a non-invasive therapy approach to help improve balance, mobility and physical function. Interested persons will be asked to contact the Principal and co-Investigator (PI and Co-I) through telephone or email. Participant screening, contact, and enrollment will be undertaken over the telephone by a student involved in the project with the supervision of the Investigators. Those who are interested after the description will be screened for inclusion criteria. Participants meeting eligibility criteria who are interested in participating will be scheduled for a single test session for the provision of informed consent, demographic and anthropometric characteristics, and assessments of balance, mobility and physical function outcomes in the Department of Kinesiology and Physical Education. Participants will then be randomly assigned into either the KTG or STG group using concealed allocation. Participants will undertake the respective group-type tape application and will undergo the same assessment protocol as done for baseline. Data-analysis Dr. Zhang and Dr. Sebastião will be responsible for data analysis using SPSS software 24 version (SPSS Inc. Armonk, NY: IBM Corp.). The effect of the intervention will be examined using Condition × Time mixed-factor ANOVA with significance set a IP<.05. The partial eta-squared estimate for the interaction term from the ANOVA will inform power analyses for future Phase II trials, and the intra-correlation coefficient for test-retest reliability for the control group will inform the reliability estimate for the power analyses. ;

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

• NCT number: NCT03804047
• Study type: Interventional
• Source: Northern Illinois University
• Contact: Shuqi Zhang, PhD
• Phone: 2254567821
• Email: szhang3@niu.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Completion date: December 31, 2021