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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03263455
Other study ID # KN2017
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 14, 2017
Last updated August 25, 2017
Start date September 1, 2017
Est. completion date August 1, 2018

Study information

Verified date August 2017
Source Universita di Verona
Contact Valentina Varalta, PS
Phone 00390458124950
Email valentina.varalta@univr.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date August 1, 2018
Est. primary completion date November 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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 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

Locations

Country Name City State
Italy Azienta Ospedaliera, SSO Rehabilitation Unit, Verona Verona Italy, Verona
Italy Azienta Ospedaliera, SSO Rehabilitation Unit, Verona Verona

Sponsors (1)

Lead Sponsor Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Stars Cancellation Test change in number of stars deleted Baseline time 0 and up to 4 weeks
Secondary Number of letter delete during the Letter Cancellation Test Baseline time 0 and up to 4 weeks
Secondary Number of Error assessed during the Cervical Joint Position Error Test Baseline time 0 and up to 4 weeks
Secondary Degree of Active Range of Motion (AROM) during left rotation Baseline time 0 and up to 4 weeks
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