Kinesio-Taping in Stroke Patients With Visuospatial Neglect

NCT ID: NCT03263455

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-08-01

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.

Conditions

Stroke; Motor Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Kinesio taping group

Intervention Type: OTHER

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 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

Group Type: SHAM_COMPARATOR

Sham Taping

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Nicola Smania, MD, Clinical Professor

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicola Smania, MD

Role: PRINCIPAL_INVESTIGATOR

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

Alessandro Picelli, MD

Role: STUDY_DIRECTOR

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

Locations

Azienta Ospedaliera, SSO Rehabilitation Unit, Verona

Verona, Italy, Verona, Italy

Azienta Ospedaliera, SSO Rehabilitation Unit, Verona

Verona, , Italy

Countries

Italy

Central Contacts

Valentina Varalta, PS

Role: CONTACT

valentina.varalta@univr.it

00390458124950

Daniele Munari, PT

Role: CONTACT

daniele.munari@univr.it

00390458124950

Other Identifiers

KN2017

Identifier Type: -

Identifier Source: org_study_id