search
Back to results

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 (CTPT)

Primary Purpose

Post Stroke Shoulder Subluxation

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
california tri-pull taping
Sponsored by
Maharishi Markendeswar University (Deemed to be University)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Stroke Shoulder Subluxation

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MMIPR

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 22, 2015
Last Updated
March 25, 2015
Sponsor
Maharishi Markendeswar University (Deemed to be University)
search

1. Study Identification

Unique Protocol Identification Number
NCT02399904
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maharishi Markendeswar University (Deemed to be University)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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 1.5" cotton undercover tape (VPK, Chennai) and a 1" 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Stroke Shoulder Subluxation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
california tri-pull taping
Other Intervention Name(s)
CTPT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Accromio humeral distance (AHD) as measured by Digital Vernier caliper
Description
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.
Time Frame
1 month
Title
Pain at rest as measured by Visual analogue scale (VAS)
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Active flexion (AFLXN) range of motion as assessed by Goniometric measurement
Description
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.
Time Frame
1 month
Title
Motor recovery of the upper extremity as assessed by Fugl-Meyer assessment for upper extremity (FMA)
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute stroke A minimum of 5 mm (0.2 in.) shoulder subluxation in the involved upper extremity. MMSE score ˃ 23. Age (35-70 yrs.) and of either sex. Exclusion Criteria: 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. Individual affected from neurological disorder other than stroke. Un-cooperative patients. Individuals with psychosomatic disorder.
Facility Information:
Facility Name
MMIPR
City
Ambala
State/Province
Haryana
ZIP/Postal Code
133207
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs