The Kinesio-taping for the Prevention of Painful Shoulder and for the Functional Recovery of Upper Limb After Stroke
Condition: Stroke, Rehabilitation
MeSH terms: Stroke
Study type: Interventional

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.
    

Intervention name(s): Kinesio Tape Group; Control Group
Intervention type(s): Device; Device
Intervention description(s): The application of the KT consists of 6 strips of I-shaped tape adhered to the skin areas of the shoulder; KT application on the deltoid but without support function
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Kinesio tape; Pain; Preventative Care; Spasticity; Muscle; Stroke; Rehabilitation; Functional Performance