Kinesio-Taping in Stroke Patients With Visuospatial Neglect

NCT03263455 | Unknown DMC

• 1 other identifier: KN2017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Keywords

neglect,; stroke,; rehabilitation,; range of motion

Outcome Measures

Primary Outcomes (1)

• The Stars Cancellation Test change in number of stars deleted

  Baseline time 0 and up to 4 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

Kinesio Taping group

EXPERIMENTAL

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

Sham Taping group

SHAM COMPARATOR

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

Interventions

Kinesio taping group 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.

Kinesio Taping group

Sham Taping 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

Sham Taping group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (2)

Azienta Ospedaliera, SSO Rehabilitation Unit, Verona

Verona, Italy, Verona, 37134, Italy

Location

Azienta Ospedaliera, SSO Rehabilitation Unit, Verona

Verona, 37134, Italy

Location

MeSH Terms

Conditions

Stroke; Motor Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Valentina Varalta, PS

CONTACT

00390458124950; valentina.varalta@univr.it

Daniele Munari, PT

CONTACT

00390458124950; daniele.munari@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 28, 2017
• Study Start: September 1, 2017
• Primary Completion: November 30, 2017
• Study Completion: August 1, 2018
• Last Updated: August 28, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)