NCT05426694

Brief Summary

In patients after open-heart surgery, the complaint of scapular dyskinesia is very common. It occurs due to the weakness of the muscles surrounding the scapula. In this research, investigators checked the effectiveness of scapular clock exercises in scapular dyskinesia, in post-op open heart surgery patients. There were two groups, an intervention "Active group" and a 'control group'. The patients will be randomly assigned to each group equally. The treatment session was given for a period of 4 weeks, with 3 sessions each week. They were assessed before treatment, after 2 weeks and post-intervention.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 25, 2022

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

May 25, 2022

Last Update Submit

June 20, 2022

Conditions

Keywords

Scapular dyskinesiaScapular Clock ExercisesOpen Heart Surgery

Outcome Measures

Primary Outcomes (1)

  • Shoulder pain

    Shoulder pain was assessed by using the Numeric Pain Rating (NPRS) Scale. NPRS is an 11-item Likert scale having 0 as no pain and 10 as maximum pain

    4 weeks

Secondary Outcomes (1)

  • Level of Shoulder activity limitation

    4 weeks

Other Outcomes (1)

  • Shoulder Range of Motion (ROM)

    4 weeks

Study Arms (2)

Group A

EXPERIMENTAL

The interventional group received stretching and strengthening exercises along with scapular clock exercises. For the first two weeks, only scapular clock exercises were performed by the patient actively. After 2 weeks, the subjects performed scapular clock exercises by using the thera-band.

Other: Scapular clock exercisesOther: Stretching and strengthening exercises

Group B

ACTIVE COMPARATOR

The active control group received stretching and strengthening exercises only. The stretching and strengthening exercises include corner stretch, wall-washes and pectoralis minor muscle stretch.

Other: Stretching and strengthening exercises

Interventions

In scapular clock exercises, the hand is placed on the wall in front of your body. Move the hand in direction of 12 and 6 o'clock to elevate and depress the scapula. Then move hands towards 9 o' clock and 3 o'clock direction to protract and retract the scapula. Hold each position for 10 seconds. From 3rd week and onward the patient will use thera-band and then perform clock exercises.

Also known as: Stretching and strengthening exercises (Physical Therapy)
Group A

Stretching and strengthening exercises of shoulder and scapular muscles was performed including wall washes, corner stretch, pectoral muscles stretch and wall push ups.

Group AGroup B

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients whose open heart surgery is done at least 6weeks ago.
  • Subjects having shoulder and scapular region pain.
  • % or less loss of Active ROM of shoulder in abduction, flexion and external rotation.
  • Positive Scapular assistance (SAT) and Scapular retraction test.
  • Positive findings on observational examination of scapula, showing abnormal prominence of either inferior, medial or superior border of scapula.
  • Type I and Type II scapular dyskinesia present
  • Consented to take part in the study.

You may not qualify if:

  • Bilateral shoulder involvement
  • History of previous surgery on shoulder
  • Shoulder fracture
  • Glenohumeral or acromioclavicular joint Arthritis.
  • Neuromuscular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faisalabad Institute of Cardiology

Faisalābad, Punjab Province, 34000, Pakistan

RECRUITING

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Izza Ayub, MS Physical Therapy

    The University of Faisalabad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aqsa Shahid, Doctor of Physical Therapy

CONTACT

Sana Zahir, Doctor of Physical Therapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Only the participants were masked. They did not know either they are in the interventional group or in the control group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There were 30 subjects divided equally and randomly into Group A and Group B. Group A was receive the intervention while group B will be active control group. The duration of treatment will be equal for both groups, that is 3 sessions per week for a period of 4 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Sana Zahir;PT and Dr Aqsa Shahid;PT

Study Record Dates

First Submitted

May 25, 2022

First Posted

June 22, 2022

Study Start

April 15, 2022

Primary Completion

June 20, 2022

Study Completion

June 30, 2022

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations