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The Kinesio-taping for the Prevention of Painful Shoulder and for the Functional Recovery of Upper Limb After Stroke

Primary Purpose

Stroke, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Kinesio Tape Group
Control Group
Sponsored by
I.R.C.C.S. Fondazione Santa Lucia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke, Rehabilitation focused on measuring Kinesio tape, Pain, Preventative Care, Spasticity, Muscle, Stroke, Rehabilitation, Functional Performance

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a first episode of ischemic or hemorrhagic stroke.
  • Hypotonia of the stabilizing muscles of the shoulder.
  • Enrollment within 1 month of stroke.

Exclusion Criteria:

  • • Previous trauma or chronic tendinopathies of the shoulder musculature.

    • Skin problems such as wounds or hypersensitivity.
    • Severe psychiatric or cognitive deficits.
    • Anesthesia of the hemiplegic side.
    • Severe aphasia
    • Severe neglect

Sites / Locations

  • I.R.C.C.S. Fondazione Santa Lucia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Kinesio-taping Group

Control Group

Arm Description

Conventional rehabilitative treatment (consisting in two treatments per day of 40 minutes each) plus a bi-weekly treatment focused on the joint complex of the shoulder plus Kinesio-taping (KT) treatment. The Kinesio-taping treatment consists in 4 applications of KT on the affected shoulder to be held for 5 days a week, followed by 2 days of rest to safeguard skin integrity before a further application. 5 KT strips with graded tensions will be placed on the following muscles: supraspinatus with a tension of 70%. infraspinatus with a tension of 70%. 3,4,5) deltoid (3 strips, 50% of tension) A sixth application with a tension of 90% originates at the level of the anterior face of the humeral head and it ends to the lower corner of the scapula.

Conventional rehabilitative treatment (consisting in two treatments per day of 40 minutes each), plus a bi-weekly treatment focused on the joint complex of the shoulder, plus shame KT treatment. - The CG will undergo a KT application on the deltoid but without support function with the same frequency and duration as the experimental group (shame-application).

Outcomes

Primary Outcome Measures

To assess the change of Ritchie Articular Index
The Ritchie Articular Index (RAI) is an 4 point index for the numerical measurement of joint tenderness. It grades 0: no tenderness, 1: patient complained of pain, 2: patient complained of pain and winced, 3: patient complained of pain and winced and withdrew. 0 is the better outcome, 3 is the worse outcome. The shoulder joint pain will be assessed

Secondary Outcome Measures

To assess the change of FUGL-MEYER ASSESSMENT UPPER EXTREMITY
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) evaluates aspects of movement, reflex, coordination, and speed of the shoulder, elbow, forearm, wrist and hand. Each of 33 FMA-UE items scored on a 3-point ordinal scale (0=cannot perform, 1=performs partially, 2=performs fully), so the total score ranges from a minimum of 0 (worse outcome) to a maximum of 66 points (better outcome)
To assess the change of Modified Ashwort Scale
The Modified Ashworth Scale (MAS) is a 6-points ordinal scale used to assess muscle spasticity, measuring resistance during muscle passive stretching. It grades from 0 to 5: 0 means no increase in muscle tone (better outcome) and 5 means rigid (worse outcome)

Full Information

First Posted
November 14, 2021
Last Updated
June 6, 2023
Sponsor
I.R.C.C.S. Fondazione Santa Lucia
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1. Study Identification

Unique Protocol Identification Number
NCT05156164
Brief Title
The Kinesio-taping for the Prevention of Painful Shoulder and for the Functional Recovery of Upper Limb After Stroke
Official Title
A Randomized Control Trial on the Effectiveness of Kinesio-taping in the Prevention of Painful Shoulder and in the Functional Recovery of the Hemiplegic Upper Limb in People With Stroke in Sub-acute Phase
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.R.C.C.S. Fondazione Santa Lucia

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
This RCT aims to investigate the effectiveness of the early use of Kinesio-taping (KT) together with standard physiotherapy treatment, in the prevention of the shoulder pain of the hemiplegic upper limb following a cerebral stroke compared to conventional physiotherapy without KT treatment. As a secondary outcome, this RCT aims to investigate if KT could improve functional recovery and delay the onset of spasticity. The study consists in two parallel groups of 15 participants each. The treatment and observation period will last 1 month.
Detailed Description
The following RCT single blind study will be performed in the Rehabilitative Operative Unit 4 of the I.R.C.C.S. Fondazione Santa Lucia in Rome, Italy. It aims to investigate the effectiveness of the early use of Kinesio-taping (KT) together with standard physiotherapy treatment, in the prevention of shoulder pain of the hemiplegic upper limb following a cerebral stroke, in the subacute phase. As a secondary outcome, a potential impact on functional recovery and on the onset of spasticity affecting the muscles of the upper limb will be evaluated. The early application of KT aims to prevent subluxation of the hemiplegic shoulder and therefore pain secondary to the prolonged mechanical stress of the capsulo-ligamentous and tendon structures, due to the weight of the limb in the antigravity position. A total of 30 patients will be enrolled by the investigators and randomly assigned to either the experimental group (EG) or the control group (CG). The EG, as part of the standard treatment, will be subject to a total of 4 applications of KT, each of which to be kept for 5 days a week followed by 2 days of rest, to safeguard skin integrity before a further application. The participants will be evaluated for eligibility at the admission after discharge from the Stroke Units of the local district area. The KT application will be carried out at an early stage, immediately after enrollment and possibly before the painful symptoms and subluxation are overt. The CG will undergo a KT application on the deltoid without support function, with the same frequency and duration as the EG (sham-application). The outcomes that will be evaluated are: the intensity of perceived pain (Ritchie Articular Index - RAI), the functionality of the upper limb (Fugl-Meyer Assessment - FMA-UE) and the presence of hypertonus in the muscles of the upper limb (modified Ashwort scale - MAS). The treatment lasted 4 weeks and the timing of data collection was organized as follows: T (0) - the initial assessment immediately after enrollment; T (1) - the intermediate evaluation performed before the fifth rehabilitation treatment; T (2) - the final evaluation performed at the end of the 8 treatments. Follow-up after discharge cannot currently be predicted due to hospital access restrictions due to the COVID pandemic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Rehabilitation
Keywords
Kinesio tape, Pain, Preventative Care, Spasticity, Muscle, Stroke, Rehabilitation, Functional Performance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio-taping Group
Arm Type
Experimental
Arm Description
Conventional rehabilitative treatment (consisting in two treatments per day of 40 minutes each) plus a bi-weekly treatment focused on the joint complex of the shoulder plus Kinesio-taping (KT) treatment. The Kinesio-taping treatment consists in 4 applications of KT on the affected shoulder to be held for 5 days a week, followed by 2 days of rest to safeguard skin integrity before a further application. 5 KT strips with graded tensions will be placed on the following muscles: supraspinatus with a tension of 70%. infraspinatus with a tension of 70%. 3,4,5) deltoid (3 strips, 50% of tension) A sixth application with a tension of 90% originates at the level of the anterior face of the humeral head and it ends to the lower corner of the scapula.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Conventional rehabilitative treatment (consisting in two treatments per day of 40 minutes each), plus a bi-weekly treatment focused on the joint complex of the shoulder, plus shame KT treatment. - The CG will undergo a KT application on the deltoid but without support function with the same frequency and duration as the experimental group (shame-application).
Intervention Type
Device
Intervention Name(s)
Kinesio Tape Group
Intervention Description
The application of the KT consists of 6 strips of I-shaped tape adhered to the skin areas of the shoulder
Intervention Type
Device
Intervention Name(s)
Control Group
Intervention Description
KT application on the deltoid but without support function
Primary Outcome Measure Information:
Title
To assess the change of Ritchie Articular Index
Description
The Ritchie Articular Index (RAI) is an 4 point index for the numerical measurement of joint tenderness. It grades 0: no tenderness, 1: patient complained of pain, 2: patient complained of pain and winced, 3: patient complained of pain and winced and withdrew. 0 is the better outcome, 3 is the worse outcome. The shoulder joint pain will be assessed
Time Frame
Initial assessment: after enrollment. Intermediate evaluation after 3 weeks, before the fifth treatment. Final evaluation after 5 weeks since enrollment
Secondary Outcome Measure Information:
Title
To assess the change of FUGL-MEYER ASSESSMENT UPPER EXTREMITY
Description
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) evaluates aspects of movement, reflex, coordination, and speed of the shoulder, elbow, forearm, wrist and hand. Each of 33 FMA-UE items scored on a 3-point ordinal scale (0=cannot perform, 1=performs partially, 2=performs fully), so the total score ranges from a minimum of 0 (worse outcome) to a maximum of 66 points (better outcome)
Time Frame
Initial assessment: after enrollment. Intermediate evaluation after 3 weeks, before the fifth treatment. Final evaluation after 5 weeks since enrollment
Title
To assess the change of Modified Ashwort Scale
Description
The Modified Ashworth Scale (MAS) is a 6-points ordinal scale used to assess muscle spasticity, measuring resistance during muscle passive stretching. It grades from 0 to 5: 0 means no increase in muscle tone (better outcome) and 5 means rigid (worse outcome)
Time Frame
Initial assessment: after enrollment. Intermediate evaluation after 3 weeks, before the fifth treatment. Final evaluation after 5 weeks since enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a first episode of ischemic or hemorrhagic stroke. Hypotonia of the stabilizing muscles of the shoulder. Enrollment within 1 month of stroke. Exclusion Criteria: • Previous trauma or chronic tendinopathies of the shoulder musculature. Skin problems such as wounds or hypersensitivity. Severe psychiatric or cognitive deficits. Anesthesia of the hemiplegic side. Severe aphasia Severe neglect
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Brunelli, MD
Organizational Affiliation
I.R.C.C.S. Fondazione Santa Lucia, Roma, Italy
Official's Role
Study Director
Facility Information:
Facility Name
I.R.C.C.S. Fondazione Santa Lucia
City
Roma
State/Province
RM
ZIP/Postal Code
00179
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication
IPD Sharing Access Criteria
Proposals should be directed to the personal corrisponding author's mail address.
Citations:
PubMed Identifier
27575012
Citation
Huang YC, Leong CP, Wang L, Wang LY, Yang YC, Chuang CY, Hsin YJ. Effect of kinesiology taping on hemiplegic shoulder pain and functional outcomes in subacute stroke patients: a randomized controlled study. Eur J Phys Rehabil Med. 2016 Dec;52(6):774-781. Epub 2016 Aug 30.
Results Reference
background
PubMed Identifier
3232046
Citation
Van Langenberghe HV, Hogan BM. Degree of pain and grade of subluxation in the painful hemiplegic shoulder. Scand J Rehabil Med. 1988;20(4):161-6.
Results Reference
background
PubMed Identifier
30956057
Citation
Ravichandran H, Janakiraman B, Sundaram S, Fisseha B, Gebreyesus T, Yitayeh Gelaw A. Systematic Review on Effectiveness of shoulder taping in Hemiplegia. J Stroke Cerebrovasc Dis. 2019 Jun;28(6):1463-1473. doi: 10.1016/j.jstrokecerebrovasdis.2019.03.021. Epub 2019 Apr 5.
Results Reference
background
PubMed Identifier
16719027
Citation
Griffin A, Bernhardt J. Strapping the hemiplegic shoulder prevents development of pain during rehabilitation: a randomized controlled trial. Clin Rehabil. 2006 Apr;20(4):287-95. doi: 10.1191/0269215505cr941oa.
Results Reference
background

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The Kinesio-taping for the Prevention of Painful Shoulder and for the Functional Recovery of Upper Limb After Stroke

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