Post Stroke Shoulder SubluxationPhase 1CTPTNCT02399904
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
A Phase 1 study testing california tri-pull taping in people with Post Stroke Shoulder Subluxation, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Post Stroke Shoulder Subluxation
- What is being tested?
- california tri-pull taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2012to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Post Stroke Shoulder Subluxation
- Being tested
- california tri-pull taping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
california tri-pull tapingOther
Also called CTPT
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: california tri-pull taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
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.
Measured: 1 month
Secondary outcomes (2)
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.
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startNov 2012
- Primary completionJul 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Stroke Shoulder SubluxationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subhasish Chatterjee, Maharishi Markendeswar University (Deemed to be University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399904
- Sponsor's protocol ID
- shoulder taping
- Acronym
- CTPT
- Status last verified
- Mar 2015
- First submitted
- 22 Mar 2015
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02399904
- Acronym / sponsor ID
- CTPT / shoulder taping
- Conditions
- Post Stroke Shoulder Subluxation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: california tri-pull taping |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| california tri-pull tapingAlso: CTPTTo 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. | Other | 1 |
Primary outcome
Accromio humeral distance (AHD) as measured by Digital Vernier caliper
Time frame: 1 month
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)
Time frame: 1 month
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.
2 secondary outcomes
Active flexion (AFLXN) range of motion as assessed by Goniometric measurement
Time frame: 1 month
Motor recovery of the upper extremity as assessed by Fugl-Meyer assessment for upper extremity (FMA)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
Related trials for Post Stroke Shoulder Subluxation
Not yet recruiting
Electrotherapeutic Interventions for Glenohumeral Subluxation After Stroke
Glenohumeral Subluxation, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing california tri-pull taping in people with Post Stroke Shoulder Subluxation, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accromio humeral distance (AHD) as measured by Digital Vernier caliper (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.