Efficacy of CTPT Method in the Treatment of Post Stroke Shoulder Subluxation

Subluxation of Inferior Shoulder Clinical Trial

— CTPT  

Official title:

Efficacy of California Tri-pull Taping Method in the Treatment of Post Stroke Shoulder Subluxation- A Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192476
• Other study ID #: CTPT
• Status: Completed
• Phase: Phase 1
• First received: July 15, 2014
• Last updated: July 18, 2014
• Start date: June 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Maharishi Markendeswar University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

california tri-pull taping (CTPT) method might be effective in reducing shoulder subluxation, pain, and improving active flexion range (AFLXN) range of motion, and functional recovery after stroke.

Description:

All the experimental group participants will receive conventional neuro rehabilitation for 45 minutes along with California tri-pull taping on the subluxed extremity. Lead researcher applied the CTPT method. The tape was applied as following manner.

Before the first intervention day, participants with hair on their shoulder or upper arm were asked to shave the area. Two types of tape was used, a self-adhesive 1.5ʺ cotton undercover tape and a 1ʺ rigid strapping tape. Participants placed their affected arm on a supporting surface to better approximate the humeral head back into the glenoid fossa. The three pieces of rigid tape were applied to the patient's shoulder on top of the already applied self-adhesive cotton tape. The first piece (medial) was applied from 1.5ʺ below the deltoid tuberosity running straight up the middle of the arm to 2ʺ above the top of the glenoid fossa between the clavicle and the spine of the scapula. The second piece (posterior) was located from 1.5ʺ below the deltoid tuberosity to 1.5ʺ above the middle of the spine of the scapula. The medial border of this second piece ran along the acromial process. Last, the third piece (anterior) was located from 1.5ʺ below the deltoid tuberosity to run around the front of the humeral head and over the coracoid process, up to 1.5ʺ above the clavicle. The tape will removed and new tape applied every Monday, Wednesday, and Friday and remained on the patient for 6 consecutive weeks.

Following the 6 weeks, each patients of both group was individually re-assessed and evaluated the effect of intervention and parameters were recorded. The recording and measurement obtained before and after intervention was subjected to statistical analysis and the result of that interpreted to obtain the significance of study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• 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. Mini mental status examination (MMSE) score >23.

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

5. Brunnstroms stage 1 and 2. -

Exclusion Criteria:

1. Mini mental status examination (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. Brunnstorm's stage 3 and 4.

7. Individual affected from neurological disorder other than stroke.

8. Un-cooperative patients.

9. Individuals with psychosomatic disorder

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dislocations
• Subluxation of Inferior Shoulder

Intervention

Other:
• conventional neuro rehabilitation programme
All the conventional group subjects 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 latissimus dorsa, activation of the retractors, weight bearing exercise of upper extremity, activation of supraspinatus, reaching activities, grasping, holding and release, and activity of daily living (ADL) activities. Every participant was received conventional neuro rehabilitation for 45 minutes and 5 days a week.
• California tri-pull taping (CTPT)
Two types of tape was used, a self-adhesive 1.5" cotton undercover tape and a 1" rigid strapping tape. Participants placed their affected arm on a supporting surface to better approximate the humeral head back into the glenoid fossa. The three pieces of rigid tape were applied to the patient's shoulder on top of the already applied self-adhesive cotton tape.

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	Digital Vernier caliper.	Digital Vernier caliper (Aerospace super) is used to measure the accromion- humeral distance in shoulder subluxation patients.	6 month	Yes
Secondary	Universal Goniometer	Universal Goniometer is used to measure the active shoulder flexion range of motion (AFLXN). The measurement is taken in lying position.	6 month	Yes
Secondary	Fugl-Meyer scale (FUG)	FUG scale was used to measure the upper extremity motor recovery.	6 month	Yes
Secondary	Visual analogue scale (VAS)	VAS was used to measure the post stroke shoulder subluxation pain.	6 month	Yes