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

NCT ID: NCT05156164

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-03-01

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.

Conditions

Stroke, Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Kinesio-taping Group

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:

1. supraspinatus with a tension of 70%.

2. 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.

Group Type: EXPERIMENTAL

Kinesio Tape Group

Intervention Type: DEVICE

The application of the KT consists of 6 strips of I-shaped tape adhered to the skin areas of the shoulder

Control Group

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).

Group Type: SHAM_COMPARATOR

Control Group

Intervention Type: DEVICE

KT application on the deltoid but without support function

Interventions

Kinesio Tape Group

The application of the KT consists of 6 strips of I-shaped tape adhered to the skin areas of the shoulder

Intervention Type: DEVICE

Control Group

KT application on the deltoid but without support function

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.R.C.C.S. Fondazione Santa Lucia

OTHER

Sponsor Role: lead

Responsible Party

Stefano Brunelli

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Brunelli, MD

Role: STUDY_DIRECTOR

I.R.C.C.S. Fondazione Santa Lucia, Roma, Italy

Locations

I.R.C.C.S. Fondazione Santa Lucia

Roma, RM, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 27575012 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3232046 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30956057 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16719027 (View on PubMed)

Other Identifiers

Prot. CE/PROG.937 FSL

Identifier Type: -

Identifier Source: org_study_id