- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02192476
Efficacy of CTPT Method in the Treatment of Post Stroke Shoulder Subluxation (CTPT)
Efficacy of California Tri-pull Taping Method in the Treatment of Post Stroke Shoulder Subluxation- A Randomized Clinical Trial.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Haryana
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Ambala, Haryana, India, 133207
- MMIPR
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Acute stroke.
- A minimum of 5 mm (0.2 in) shoulder subluxation in the involved upper extremity.
- Mini mental status examination (MMSE) score >23.
- Age (35-70 yrs.) and of either sex.
- Brunnstroms stage 1 and 2. -
Exclusion Criteria:
- Mini mental status examination (MMSE) score <23.
- Other musculoskeletal disorder of the affected upper extremity.
- History of trauma to the affected upper extremity.
- Hyper or hypo sensitivity disorders.
- Any skin allergy.
- Brunnstorm's stage 3 and 4.
- Individual affected from neurological disorder other than stroke.
- Un-cooperative patients.
- Individuals with psychosomatic disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: conventional
15 participants are allotted in this arm and each participants received conventional neuro rehabilitation programme 5 days a week for 6 weeks.
|
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.
|
Experimental: intervention
15 participants allotted in this arm and each participants received California tri-pull taping method along with conventional neuro rehabilitation was given 5 days a week for 6 weeks
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Digital Vernier caliper.
Time Frame: 6 month
|
Digital Vernier caliper (Aerospace super) is used to measure the accromion- humeral distance in shoulder subluxation patients.
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Universal Goniometer
Time Frame: 6 month
|
Universal Goniometer is used to measure the active shoulder flexion range of motion (AFLXN).
The measurement is taken in lying position.
|
6 month
|
Fugl-Meyer scale (FUG)
Time Frame: 6 month
|
FUG scale was used to measure the upper extremity motor recovery.
|
6 month
|
Visual analogue scale (VAS)
Time Frame: 6 month
|
VAS was used to measure the post stroke shoulder subluxation pain.
|
6 month
|
Collaborators and Investigators
Investigators
- Study Director: Senthil P Kumar, PhD, MMIPR
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTPT
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