Kinesio-Taping in Stroke Patients With Visuospatial Neglect (k-neglect)

The Effects of Kinesis-Taping Application on Cognitive Deficit and Motor Ability in Stroke Patients With Visuospatial Neglect: a Randomized Controlled Study

Stroke is the second leading cause of death worldwide and the third most common cause of disability. The effects of stroke are variable and may include impairments in motor and sensory systems, emotion and neuropsychological deficits such as a disorder of spatial awareness known as unilateral spatial neglect (USN). Approaches to ameliorate USN could be categorized in interventions as involving either bottom-up or top-down processing. The specific mechanisms underlying these effects on a number of manifestations of the USN syndrome may include the restoration of defective representations of the side of space contralateral to the lesion (contralesional), and of the ability to orient spatial attention contralesionally, through complex patterns of activation of both the damaged right hemisphere, and the contralateral left hemisphere, with differences related to the specific stimulation delivered to the patient. In recent years, increasing cutaneous stimuli through neuromuscular kinesiotaping has been proposed to enhance somatosensory inputs (24) and such as method could have positive effects on USN. The aim of the present study was to assess the effect of KTM applied on the sternocleidomastoid muscle controlateral side of the lesions in improving USN deficits in individuals with stroke patient in sub-acute phase. The hypothesis is that the KTM application could improved cognitive tests for assessing USN, motor deficits and kinesthetic neck sensibility.

Study Overview

• Status: Unknown
• Conditions: Stroke; Motor Disorder
• Intervention / Treatment: Other: Kinesio taping group; Other: Sham Taping

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valentina Varalta, PS; Phone Number: 00390458124950; Email: valentina.varalta@univr.it
• Study Contact Backup: Name: Daniele Munari, PT; Phone Number: 00390458124950; Email: daniele.munari@univr.it

Study Locations

• Italy
  • Verona, Italy, 37134
    • Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
  • Italy, Verona
    • Verona, Italy, Verona, Italy, 37134
      • Azienta Ospedaliera, SSO Rehabilitation Unit, Verona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients affected by stroke from cerebral ischemia or hemorrhage that occurred ⩽ 30 days before;
• presence of visuospatial neglect (Star Cancellation Test' score < 50)
• able to actively rotate the head toward left side in closed eyes condition.

Exclusion Criteria:

• the presence of dementia (Mini-Mental State Examination correct score lower than 23,80)
• severe deficit of comprehension
• psychiatric disorders
• hemianopsia patients (diagnosed with perimetry) patients or their family members did not consent to this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kinesio Taping group; The tape in the KT group was applied with paper-off tension, which means applying the tape directly to the skin as it comes off the paper backing (approximately with 15% to 25% of available tension).	Other: Kinesio taping group; The tape in the KT group will be applied with paper-off tension, which means applying the tape directly to the skin as it comes off the paper backing (approximately with 15% to 25% of available tension). KinesioTape will be applied over the SCM dystonic muscle by means of 2 "I-strips": the first strip will be placed on the medial (sternal) head and the second will be applied on the lateral (clavicular) head of the SCM muscle. KinesioTape was applied from the mastoid bone to the clavicle (rostrocaudal direction) with the SCM placed in a position of maximum stretching.
Sham Comparator: Sham Taping group; Patients in the ST group, smaller "I-strips" of KinesioTape were used and they were applied, with no tension and without stretching the muscles, perpendicularly to the muscle belly (starting from the middle and progressing to each side) over the same dystonic muscles as in the Kinesio Taping group	Other: Sham Taping; Patients in the ST group, smaller "I-strips" of KinesioTape will be used and they will be applied, with no tension and without stretching the muscles, perpendicularly to the muscle belly (starting from the middle and progressing to each side) over the same dystonic muscles as in the experimental group. Although the specific therapeutic elements of KinesioTaping (ie, longitudinal stretch, start and ending point tape application) will be removed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Stars Cancellation Test change in number of stars deleted	Baseline time 0 and up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of letter delete during the Letter Cancellation Test	Baseline time 0 and up to 4 weeks
Number of Error assessed during the Cervical Joint Position Error Test	Baseline time 0 and up to 4 weeks
Degree of Active Range of Motion (AROM) during left rotation	Baseline time 0 and up to 4 weeks

Collaborators and Investigators

• Sponsor: Universita di Verona
• Investigators: Principal Investigator: Nicola Smania, MD, Neuromotor and Cognitive Rehabilitation Center Department for Neurosciences, Biomedicine and Movement Sciences University of Verona, Verona, Italy P.zza L.A. Scuro, 10 37134 Verona, Italia; Study Director: Alessandro Picelli, MD, Neuromotor and Cognitive Rehabilitation Center Department for Neurosciences, Biomedicine and Movement Sciences University of Verona, Verona, Italy P.zza L.A. Scuro, 10 37134 Verona, Italia

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): November 30, 2017
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 25, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: stroke,; rehabilitation,; range of motion; neglect,
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Motor Disorders
• Other Study ID Numbers: KN2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No