Clinical trial NCT02192476: Efficacy of CTPT Method in the Treatment of Post Stroke Shoulder Subluxation
Official title: Efficacy of California Tri-pull Taping Method in the Treatment of Post Stroke Shoulder Subluxation- A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Subluxation of Inferior Shoulder
Keywords: Stroke, subluxation
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 1.5" 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. The first piece (medial) was applied from 1.5" below the deltoid tuberosity running straight up the middle of the arm to 2" above the top of the glenoid fossa between the clavicle and the spine of the scapula. The second piece (posterior) was located from 1.5" below the deltoid tuberosity to 1.5" 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 1.5" below the deltoid tuberosity to run around the front of the humeral head and over the coracoid process, up to 1.5" 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.

Eligibility criteria: 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

Primary outcomes:
measure: Digital Vernier caliper.
timeFrame: 6 month
Secondary outcomes:
measure: Universal Goniometer
timeFrame: 6 month
measure: Fugl-Meyer scale (FUG)
timeFrame: 6 month
measure: Visual analogue scale (VAS)
timeFrame: 6 month
Other outcomes:
Locations:
city: Ambala
country: India
facility: MMIPR
state: Haryana
Study officials:
affiliation: MMIPR
name: Senthil P Kumar, PhD
role: STUDY_DIRECTOR
References: