Subluxation of Inferior ShoulderPhase 1CTPTNCT02192476
Efficacy of CTPT Method in the Treatment of Post Stroke Shoulder Subluxation
A Phase 1 study testing conventional neuro rehabilitation programme and California tri-pull taping (CTPT) in people with Subluxation of Inferior Shoulder, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Subluxation of Inferior Shoulder
- What is being tested?
- conventional neuro rehabilitation programme and California tri-pull taping (CTPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2013to Jul 2014
- 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.
- Mini mental status examination (MMSE) score >23.
- Age (35-70 yrs.) and of either sex.
- Brunnstroms stage 1 and 2. -
Who cannot join
- 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.
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- 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
Official title: Efficacy of California Tri-pull Taping Method in the Treatment of Post Stroke Shoulder Subluxation- A Randomized Clinical Trial.
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.
Read the 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.
- Conditions
- Subluxation of Inferior Shoulder
- Being tested
- conventional neuro rehabilitation programme, California tri-pull taping (CTPT)
- Keywords
- Stroke, subluxation
- Medical subject headings
- Stroke, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional neuro rehabilitation programmeOther
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| conventional | Active comparator | 15 participants are allotted in this arm and each participants received conventional neuro rehabilitation programme 5 days a week for 6 weeks. Receives: Other: conventional neuro rehabilitation programme |
| intervention | Experimental | 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 Receives: Other: conventional neuro rehabilitation programme; Other: California tri-pull taping (CTPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Vernier caliper.
Digital Vernier caliper (Aerospace super) is used to measure the accromion- humeral distance in shoulder subluxation patients.
Measured: 6 month
Secondary outcomes (3)
Universal Goniometer
Universal Goniometer is used to measure the active shoulder flexion range of motion (AFLXN). The measurement is taken in lying position.
Measured: 6 month
Fugl-Meyer scale (FUG)
FUG scale was used to measure the upper extremity motor recovery.
Measured: 6 month
Visual analogue scale (VAS)
VAS was used to measure the post stroke shoulder subluxation pain.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subluxation of Inferior ShoulderStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 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)
- Investigators
- Senthil P Kumar, PhD, Study director, MMIPR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192476
- Sponsor's protocol ID
- CTPT
- Acronym
- CTPT
- Status last verified
- Jul 2014
- First submitted
- 15 Jul 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of California Tri-pull Taping Method in the Treatment of Post Stroke Shoulder Subluxation- A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02192476
- Acronym / sponsor ID
- CTPT / CTPT
- Conditions
- Subluxation of Inferior Shoulder
- Keywords
- Stroke, subluxation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Jul 2014 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional | Active comparator | Other: conventional neuro rehabilitation programme15 participants are allotted in this arm and each participants received conventional neuro rehabilitation programme 5 days a week for 6 weeks. |
| intervention | Experimental | Other: conventional neuro rehabilitation programme, Other: California tri-pull taping (CTPT)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 |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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. -
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| conventional neuro rehabilitation programmeAll 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. | Other | conventional, intervention |
| 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. | Other | intervention |
Primary outcome
Digital Vernier caliper.
Time frame: 6 month
Digital Vernier caliper (Aerospace super) is used to measure the accromion- humeral distance in shoulder subluxation patients.
3 secondary outcomes
Universal Goniometer
Time frame: 6 month
Fugl-Meyer scale (FUG)
Time frame: 6 month
Visual analogue scale (VAS)
Time frame: 6 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 22 Jul 2014.
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.
Senthil P Kumar, PhD study director
MMIPR
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 conventional neuro rehabilitation programme and California tri-pull taping (CTPT) in people with Subluxation of Inferior Shoulder, 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 5 inclusion and 9 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 22 Jul 2014. 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?
Digital Vernier caliper. (time frame: 6 month). 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 22 Jul 2014.