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STRIPS: Shoulder Taping Reduces Injury and Pain in Stroke

This study has been completed.
Sponsor:
Collaborators:
Uppal Neuro Hospital
Heart and Brain Center, Guntur, Andhra Pradesh, India
Information provided by (Responsible Party):
Christian Medical College and Hospital, Ludhiana, India
ClinicalTrials.gov Identifier:
NCT01062308
First received: February 3, 2010
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Stroke
Shoulder Injury
Procedure: Taping and Sham Taping
Procedure: Sham Taping
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Christian Medical College and Hospital, Ludhiana, India:

Primary Outcome Measures:
  • Pain: Visual Analog Scale [ Time Frame: 14 days and 30 days ] [ Designated as safety issue: Yes ]
    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:
  • Passive Range of Motion (ROM) [ Time Frame: 14 days and 30 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 162
Study Start Date: August 2009
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  1. Positioning technique
  2. Handling technique
  3. Range of motion exercises
  4. 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.
Other Name: Sham Taping

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062308

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

No publications provided by Christian Medical College and Hospital, Ludhiana, India

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Study First Received: February 3, 2010
Results First Received: June 18, 2012
Last Updated: March 7, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Christian Medical College and Hospital, Ludhiana, India:
Stroke
Taping
Pain
Shoulder Injury

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 19, 2014