Kinesio-Taping in Stroke Patients With Visuospatial Neglect (k-neglect)
Primary Purpose
Stroke, Motor Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Kinesio taping group
Sham Taping
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring neglect,, stroke,, rehabilitation,, range of motion
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.
Sites / Locations
- Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
- Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Kinesio Taping group
Sham Taping group
Arm Description
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).
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
Outcomes
Primary Outcome Measures
The Stars Cancellation Test change in number of stars deleted
Secondary Outcome Measures
Number of letter delete during the Letter Cancellation Test
Number of Error assessed during the Cervical Joint Position Error Test
Degree of Active Range of Motion (AROM) during left rotation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03263455
Brief Title
Kinesio-Taping in Stroke Patients With Visuospatial Neglect
Acronym
k-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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Anticipated)
Primary Completion Date
November 30, 2017 (Anticipated)
Study Completion Date
August 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Motor Disorder
Keywords
neglect,, stroke,, rehabilitation,, range of motion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kinesio Taping group
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham Taping group
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Kinesio taping group
Intervention Description
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
Intervention Name(s)
Sham Taping
Intervention Description
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
Primary Outcome Measure Information:
Title
The Stars Cancellation Test change in number of stars deleted
Time Frame
Baseline time 0 and up to 4 weeks
Secondary Outcome Measure Information:
Title
Number of letter delete during the Letter Cancellation Test
Time Frame
Baseline time 0 and up to 4 weeks
Title
Number of Error assessed during the Cervical Joint Position Error Test
Time Frame
Baseline time 0 and up to 4 weeks
Title
Degree of Active Range of Motion (AROM) during left rotation
Time Frame
Baseline time 0 and up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valentina Varalta, PS
Phone
00390458124950
Email
valentina.varalta@univr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Daniele Munari, PT
Phone
00390458124950
Email
daniele.munari@univr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Smania, MD
Organizational 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
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alessandro Picelli, MD
Organizational 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
Official's Role
Study Director
Facility Information:
Facility Name
Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
City
Verona
State/Province
Italy, Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
City
Verona
ZIP/Postal Code
37134
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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Kinesio-Taping in Stroke Patients With Visuospatial Neglect
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