Clinical trial NCT03263455: Kinesio-Taping in Stroke Patients With Visuospatial Neglect
Official title: The Effects of Kinesis-Taping Application on Cognitive Deficit and Motor Ability in Stroke Patients With Visuospatial Neglect: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Motor Disorder
Keywords: neglect,
stroke,
rehabilitation,
range of motion
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2017-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The Stars Cancellation Test change in number of stars deleted
timeFrame: Baseline time 0 and up to 4 weeks
Secondary outcomes:
measure: Number of letter delete during the Letter Cancellation Test
timeFrame: Baseline time 0 and up to 4 weeks
measure: Number of Error assessed during the Cervical Joint Position Error Test
timeFrame: Baseline time 0 and up to 4 weeks
measure: Degree of Active Range of Motion (AROM) during left rotation
timeFrame: Baseline time 0 and up to 4 weeks
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
state: Italy, Verona
city: Verona
country: Italy
facility: Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
Study officials:
affiliation: 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
name: Nicola Smania, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 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
name: Alessandro Picelli, MD
role: STUDY_DIRECTOR
References: