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

NCT03804047 | Unknown

• 1 other identifier: HS18-0012
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Multiple Sclerosis

Keywords

Kinesio Tape; Physical functioning; Disability

Outcome Measures

Primary Outcomes (6)

• Static Balance Performance

  Center of Pressure (CoP) related measures collected from force plate

  10minutes

• Timed and Up and Go

  a measure of functional mobility

  6minutes

• Timed 25-foot Walk

  a measure of walking speed

  6minutes

• Six-minute Walking Test

  a measure of walking endurance

  10minutes

• Six-spot Step Test

  a measure of lower-body coordination

  6minutes

• The Short Physical Performance Battery

  represent a recently validity measure of physical function in persons with MS

  6minutes

Study Arms (2)

Kinesio Tape (KTG)

EXPERIMENTAL

Participants allocated into the 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 (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 a complete structure for the procedure.

Other: kinesio tape

Sham Tape (STG)

SHAM COMPARATOR

Participants allocated into the STG will receive a single time application of an inflexible tape (i.e., sham tape) in the same body segments as the intervention condition. Tape application will be conducted in a private room with a complete structure for the procedure.

Other: kinesio tape

Interventions

kinesio tape OTHER

kinesio tape is a therapeutic method used in the treatment of various musculoskeletal and neuromuscular deficits to provide support for muscles and increase or inhibit muscle recruitment, to correct joint malalignment, decrease swelling, and pain relieve

Kinesio Tape (KTG); Sham Tape (STG)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• clinically definitive diagnosis of MS
• aged 18 - 50 years
• relapse-free for the past 30 days and
• ability to walk with or without an assistive device (i.e., cane, but not walker/rollator).
• must be willing to complete in-person assessments at a university research setting

You may not qualify if:

• use wheelchair, crutches and walker
• have moderate cognitive impairment based on the modified Telephone Interview for Cognitive Status (i.e., moderate cognitive impairment, ≤ 12 points).

Sponsors & Collaborators

• Northern Illinois University: lead

Study Sites (1)

Department of Kinesiology and Physical Education. Northern Illinois University

DeKalb, Illinois, 60115, United States

RECRUITING

Related Publications (23)

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  BACKGROUND

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MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment

Study Officials

• Emerson Sebastiao, PhD

  Department of Kinesiology and Physical Education - Northern Illinois University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuqi Zhang, PhD

CONTACT

2254567821; szhang3@niu.edu

Emerson Sebastiao, PhD

CONTACT

(815) 753-3656; esebastiao@niu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization will done using concealed allocation with the use of opaque envelopes. Envelopes will be spread out over a table and participants will choose one to give it to the Physical Therapist (PT). The PT will open the envelope to check the type of tape (without showing or saying it to the participant) to be applied (kinesio or Sham tape). Participants are unaware about tape categorization "treatment" or "placebo" as the tapes are unlabeled.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two arm randomized controlled trial (Pre; Post)

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 15, 2019
• Study Start: January 1, 2019
• Primary Completion: December 25, 2021
• Study Completion: December 31, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)