k-neglect: Kinesio-Taping in Stroke Patients With Visuospatial Neglect

Sponsor

Universita di Verona (Other)

Overall Status

Unknown status

CT.gov ID

NCT03263455

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Motor Disorder	Other: Kinesio taping group Other: Sham Taping	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2017

Anticipated Primary Completion Date :

Nov 30, 2017

Anticipated Study Completion Date :

Aug 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The Stars Cancellation Test change in number of stars deleted [Baseline time 0 and up to 4 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienta Ospedaliera, SSO Rehabilitation Unit, Verona	Verona	Italy, Verona	Italy	37134
2	Azienta Ospedaliera, SSO Rehabilitation Unit, Verona	Verona		Italy	37134

Sponsors and Collaborators

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