Effect of California Tri-pull Taping Method on Shoulder Subluxation, Pain, Active Range of Motion and Upper Limb Functional Recovery After Stroke - A Pre Test Post Test Design

Post Stroke Shoulder Subluxation Clinical Trial

— CTPT  

Official title:

Effect of California Tri-pull Taping Method on Shoulder Subluxation, Pain, Active Range of Motion and Upper Limb Functional Recovery After Stroke - A Pre Test Post Test Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399904
• Other study ID #: shoulder taping
• Status: Completed
• Phase: Phase 1
• First received: March 22, 2015
• Last updated: March 25, 2015
• Start date: November 2012
• Est. completion date: October 2013

Study information

• Verified date: March 2015
• Source: Maharishi Markendeswar University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study was conducted to check the effect of California tri-pull taping method on post stroke shoulder subluxation, prior to conduct a large randomized clinical trial this study was conducted, and the result of the study was promising for the treatment of shoulder subluxation.

Description:

Intervention was given by the lead researcher who was trained for the taping techniques.

Prior to give taping method participants who have hair around the shoulder was instructed to remove hair. Two types of tape was used, a self-adhesive 1.5ʺ cotton undercover tape (VPK, Chennai) and a 1ʺ rigid strapping tape (VPK, Chennai). To approximate the humeral head into the glenoid cavity participants were instructed to place their affected arm on a wooden table. Three piece of tape was used, firstly the investigators applied cotton undercover pre tape and then the investigators applied the rigid post tape on it. First piece (middle) of tape was applied from 1.5 inches below the deltoid tuberosity up to 2 inches above the glenoid cavity. Second piece (posterior) was applied from 1.5 inches below the deltoid tuberosity upto the 1.5 inches above the mid spine of scapula. Third piece (anterior) was applied from the 1.5 inches below the deltoid tuberosity upto the 1.5 inches above the clavicle. (Figure-1). The tape was removed and new tape applied every Monday, Wednesday, and Friday and remained on the patient for 6 consecutive weeks.

All the participants were received standardized conventional neuro rehabilitation programme. The conventional neuro rehabilitation treatment includes, active, and passive range of motion exercise, bilateral activation of pectoralis major, activation of lattisimus dorsi, activation of the retractors, weight bearing exercise of upper extremity, activation of supraspinatus, reaching activities, grasping, holding and release, and ADL activities. Every participant was received conventional neuro rehabilitation for 45 minutes and 5 days a week.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Acute stroke

2. A minimum of 5 mm (0.2 in.) shoulder subluxation in the involved upper extremity.

3. MMSE score ? 23.

4. Age (35-70 yrs.) and of either sex.

Exclusion Criteria:

1. MMSE score ?23.

2. Other musculoskeletal disorder of the affected upper extremity.

3. History of trauma to the affected upper extremity.

4. Hyper or hypo sensitivity disorders.

5. Any skin allergy.

6. Individual affected from neurological disorder other than stroke.

7. Un-cooperative patients.

8. Individuals with psychosomatic disorder.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dislocations
• Post Stroke Shoulder Subluxation
• Stroke

Intervention

Other:
• california tri-pull taping
To approximate the humeral head into the glenoid cavity participants were instructed to place their affected arm on a wooden table. Three piece of tape was used, firstly we applied cotton undercover pre tape and then we applied the rigid post tape on it. First piece (middle) of tape was applied from 1.5 inches below the deltoid tuberosity up to 2 inches above the glenoid cavity. Second piece (posterior) was applied from 1.5 inches below the deltoid tuberosity upto the 1.5 inches above the mid spine of scapula. Third piece (anterior) was applied from the 1.5 inches below the deltoid tuberosity upto the 1.5 inches above the clavicle.

Locations

Country	Name	City	State
India	MMIPR	Ambala	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Maharishi Markendeswar University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accromio humeral distance (AHD) as measured by Digital Vernier caliper	Participants were evaluated for accromio humeral distance (AHD), by using digital Vernier calliper. The measurement was taken in centimetre from the inferior aspect of the acromion to the superior aspect of the humeral head. The patient was in sitting position such a way that tested upper extremity was hanged freely. Paci et al 21 showed in a systemic review that caliper method was reliable for shoulder subluxation measurement. The r value of caliper method was 0.93 and ICC was 0.68. This method also achieved a good validity score, which was 0.747.	1 month	Yes
Primary	Pain at rest as measured by Visual analogue scale (VAS)	pain at rest was measured by using a 10 cm visual analogue scale (VAS). In VAS 1 indicating no pain where 10 indicating extreme pain. Crossley et al 22 conducted a study to assess the reliability of VAS in patella femoral pain. 71 participants were recruited, out of which 20 participants completed the reliability study. He took 3 types of pain readings such as usual pain, worst pain and activity pain. ICC score for usual pain was 0.56, for worst pain it was 0.76 and for activity pain it was 0.83. He also concluded that VAS scale was reliable and valid measure for assessing patella femoral pain.	1 month	Yes
Secondary	Active flexion (AFLXN) range of motion as assessed by Goniometric measurement	Active flexion (AFLXN) range of motion was assessed using goniometric measurement for shoulder flexion. Active shoulder flexion range was assessed in supine position to avoid trick movement that may happen in sitting position. Hayes et al 23 conducted a study to determine the inter-rater and intra-rater reliability of five methods for assessing shoulder range of motion. For inter-rater reliability 4 raters took measurement on 8 subjects and for intra-rater reliability one rater took 3 readings within 48 hours. The results of the study showed that the ICC value for goniometric flexion ROM measurement was 0.69 for inter-rater reliability. ICC value for intra-rater reliability was 0.53 for flexion ROM. He also concluded that goniometer has fair-good reliability to measure shoulder flexion range of motion.	1 month	Yes
Secondary	Motor recovery of the upper extremity as assessed by Fugl-Meyer assessment for upper extremity (FMA)	The motor recovery of the upper extremity was assessed by using Fugl-Meyer assessment for upper extremity. The maximum score for upper extremity motor assessment is 66. Sanford 24 checked the reliability of the Fugl-Meyer assessment for testing Motor Performance in Patients Following Stroke on 12 patients. The overall reliability was high, ICC = 0.96.	1 month	Yes