Stroke, Rehabilitation
Conditions
Keywords
Kinesio tape, Pain, Preventative Care, Spasticity, Muscle, Stroke, Rehabilitation, Functional Performance
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.
Interventions
DEVICEKinesio Tape Group
The application of the KT consists of 6 strips of I-shaped tape adhered to the skin areas of the shoulder
DEVICEControl Group
KT application on the deltoid but without support function
Sponsors
I.R.C.C.S. Fondazione Santa Lucia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the change of Ritchie Articular Index | Initial assessment: after enrollment. Intermediate evaluation after 3 weeks, before the fifth treatment. Final evaluation after 5 weeks since enrollment | 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
| Measure | Time frame | Description |
|---|---|---|
| To assess the change of FUGL-MEYER ASSESSMENT UPPER EXTREMITY | Initial assessment: after enrollment. Intermediate evaluation after 3 weeks, before the fifth treatment. Final evaluation after 5 weeks since enrollment | 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 | Initial assessment: after enrollment. Intermediate evaluation after 3 weeks, before the fifth treatment. Final evaluation after 5 weeks since enrollment | 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) |
Countries
Italy
Outcome results
None listed