NCT05156164

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: I.R.C.C.S. Fondazione Santa Lucia · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Kinesio Tape Group	The application of the KT consists of 6 strips of I-shaped tape adhered to the skin areas of the shoulder
DEVICE	Control Group	KT application on the deltoid but without support function

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-10-01
• Completion: 2023-03-01
• First posted: 2021-12-14
• Last updated: 2023-06-07

Locations

1 site across 1 country: Italy