STRIPS: Shoulder Taping Reduces Injury and Pain in Stroke (STRIPS)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Stroke; Shoulder Injury	Procedure: Taping and Sham Taping; Procedure: Sham Taping	Phase 3

  Show Detailed Description

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	162 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	The Effectiveness of Taping Technique Versus Conventional Techniques in Prevention of Shoulder Injuries in Patients With Acute Stroke-A Prospective, Randomized, Interventional, Outcome Blinded (PROBE Design), Parallel Design Trial
Study Start Date :	August 2009
Actual Primary Completion Date :	March 2012
Actual Study Completion Date :	April 2012

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Taping; The tri-pull method of taping was used.Taping was initiated by first applying three, two-inch wide and approximately ten-inch long, pieces of elastic adhesive tape strips. The first strip was applied from the mid-humerus deltoid tuberosity across the scapula. The second strip was applied from the deltoid tuberosity across the clavicle to the mid-clavicle, but before the supra-sternal notch. The third strip was placed from the deltoid tuberosity over the acromion process to the neck.	Procedure: Taping and Sham Taping; Taping shoulder with Hospiplast tape. Taping the shoulder after acute stroke to prevent shoulder injury and pain. Taping the shoulder after acute stroke and compare with sham taping group. Treatments: Positioning technique; Handling technique; Range of motion exercises; Taping technique; Other Name: Shoulder Taping in Stroke
Active Comparator: Sham Taping; This was done using the same tapes. Three strips of tapes were applied in same position without repositioning the joint. All other Physiotherapy measures like positioning, handling technique and range of motion exercises were equally done for both the groups.	Procedure: Sham Taping; Shoulder Taping for 14 days which will be changed after every 3 days.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Pain: Visual Analog Scale [ Time Frame: 14 days and 30 days ]
   Visual analog scale (VAS) is an 11-point scale displayed on a 100 mm horizontal line, ranging from 0 ("No Pain") to 100 ("Worst Pain Imaginable") Shoulder pain and disability index (SPADI) is a 13-item questionnaire that consists of 2 subscales for pain (5 items) and disability (8 items), which is scored by taking an average of the 2 subscales. Scores range from 0 to 100, with higher scores indicating greater pain and disability

Secondary Outcome Measures :

1. Passive Range of Motion (ROM) [ Time Frame: 14 days and 30 days ]
   Passive range of motion (ROM) of shoulder was measured with full circle goniometer. The normal range of movement of flexion and abduction is 180 degree.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Stroke patients both ischemic and hemorrhagic with upper limb weakness within 48 hours after the ictus
2. Age over 18 years
3. Brunnstrom's stage of recovery 1 and 2
4. Patients willing to participate in the study

Exclusion Criteria:

1. Patients with Glasgow coma scale of <7
2. Patients on ventilator
3. Uncooperative patients
4. Patients having previous history of shoulder injury
5. Patients with Wernicke's aphasia
6. Patients having previous history of shoulder pain
7. Any previous history of skin allergy to tape

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

India
Christian Medical College
Ludhiana, Punjab, India, 141008
Jeyaraj D Pandian
Ludhiana, Punjab, India, 141008

Sponsors and Collaborators

Christian Medical College and Hospital, Ludhiana, India

Uppal Neuro Hospital

Heart and Brain Center, Guntur, Andhra Pradesh, India

Investigators

Principal Investigator:	Jeyaraj D Pandian, MD DM FRACP	Christian Medical College, Ludhiana

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pandian JD, Kaur P, Arora R, Vishwambaran DK, Toor G, Mathangi S, Vijaya P, Uppal A, Kaur T, Arima H. Shoulder taping reduces injury and pain in stroke patients: randomized controlled trial. Neurology. 2013 Feb 5;80(6):528-32. doi: 10.1212/WNL.0b013e318281550e. Epub 2013 Jan 23.

Responsible Party:	Christian Medical College and Hospital, Ludhiana, India
ClinicalTrials.gov Identifier:	NCT01062308 History of Changes
Other Study ID Numbers:	Jeyaraj Pandian; CMC/NEU/COP/JDP/2009/001 ( Other Identifier: CMC Ludhiana )
First Posted:	February 4, 2010
Results First Posted:	March 7, 2013
Last Update Posted:	March 12, 2013
Last Verified:	March 2013

Keywords provided by Christian Medical College and Hospital, Ludhiana, India:

Stroke; Taping; Pain; Shoulder Injury

Additional relevant MeSH terms:

Wounds and Injuries; Stroke; Shoulder Injuries; Cerebrovascular Disorders; Brain Diseases	Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases