Phase 3
N=162
STRIPS: Shoulder Taping Reduces Injury and Pain in Stroke
Stroke · Shoulder Injury
Bottom Line
View on ClinicalTrials.gov: NCT01062308 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Pain: Visual Analog Scale — -2.3; 1.4; -9.2; 2.6 mm — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Taping and Sham Taping (Procedure); Sham Taping (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Christian Medical College and Hospital, Ludhiana, India
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain: Visual Analog Scale |
-2.3; 1.4; -9.2; 2.6 | 0.03 sig |
| SECONDARY Passive Range of Motion (ROM) |
2.9; -4.1; 4.9; -1.7 | 0.16 |
Summary
Background and Rationale: The most commonly seen disabilities in stroke patients are shoulder injuries such as shoulder pain, glenohumeral subluxation, spasticity of shoulder muscles, soft-tissue trauma, rotator cuff tears, and shoulder-hand syndrome.
Taping is widely used in the field of rehabilitation as both means of treatment and prevention of sports related injuries. Scarce information is available regarding the use of shoulder taping in preventing shoulder injuries in stroke patients. Aims:
To find out the effectiveness of taping technique with conventional treatment versus sham taping and conventional treatment in prevention of shoulder injuries in patients with acute stroke.
Hypothesis:
Taping technique with conventional treatment will be superior to conventional treatment alone in preventing shoulder injuries in patients with acute stroke.
Methods Research setting: Stroke unit, department of Neurology, Christian Medical College (CMC) Ludhiana, Punjab, India and College of Physiotherapy, CMC Ludhiana.
Study design: prospective, randomized, outcome blinded trial (PROBE design). Study period: Prospective for 18 months from May 2009 All stroke patients with upper limb weakness within 48 hours after the ictus and with Brunnstrom's stage of recovery 1 and 2 will be included in the study. Patients will be randomized into two groups using lottery method. The treatment arm group(Group I) include shoulder taping with conventional techniques that is(positioning, handling technique and passive range of motion exercises) and the control arm (Group II) include sham taping with conventional techniques with sham taping. A total of 80 patients in each group will be included. The plastic micropore and elastic adhesive tape will be used for taping the affected shoulder. The sham taping will be done using the same tapes but without stretching the concerned muscles and joints. The tapes will be changed every 3 days and will remain for 14 days. The outcome measures are as follows; Primary: Pain: Visual Analog Scale and Activities of daily living: Shoulder Pain and Disability Index (SPADI); Secondary: Range of motion: using a Goniometer. The outcome will be assessed by an independent physiotherapist who will be blinded to the clinical details. Patients will be followed-up at 14 days and 30 days. Statistical analyses will be done using SPSS software version 16.
Eligibility Criteria
Inclusion Criteria
- Stroke patients both ischemic and hemorrhagic with upper limb weakness within 48 hours after the ictus
- Age over 18 years
- Brunnstrom's stage of recovery 1 and 2
- Patients willing to participate in the study
Exclusion Criteria
- Patients with Glasgow coma scale of <7
- Patients on ventilator
- Uncooperative patients
- Patients having previous history of shoulder injury
- Patients with Wernicke's aphasia
- Patients having previous history of shoulder pain
- Any previous history of skin allergy to tape
Data sourced from ClinicalTrials.gov (NCT01062308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.