STRIPS: Shoulder Taping Reduces Injury and Pain in Stroke

NCT01062308 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2013-03-12

Study results available
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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.

Conditions

Interventions

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

PROCEDURE

Sham Taping

Shoulder Taping for 14 days which will be changed after every 3 days.

Sponsors & Collaborators

  • Uppal Neuro Hospital

    collaborator OTHER
  • Heart and Brain Center, Guntur, Andhra Pradesh, India

    collaborator UNKNOWN
  • Christian Medical College and Hospital, Ludhiana, India

    lead OTHER

Principal Investigators

  • Jeyaraj D Pandian, MD DM FRACP · Christian Medical College, Ludhiana

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-03-31
Completion
2012-04-30

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01062308 on ClinicalTrials.gov