- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06954220
Baduanjin Exercises on Shoulder Dysfunction Post Thyroidectomy
This study will be carried out at the outpatient clinic of the faculty of physical therapy, Cairo university, El Galaa general hosbital after referral from endocrine surgeon. Participants will perform these exercises in a room supervisor physiotherapist.
All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will investigate the effects of Baduanjin exercises on shoulder dysfunction post thyroidectomy. To assign patients to different treatment groups, a table of random numbers generated by a computer was used. Patients were allocated randomly into two groups using this method. This study will be carried out at the outpatient clinic of the faculty of physical therapy, Cairo University, El Galaa general hospital and National Cancer Institute in Cairo to be treated in the outpatient clinic after referral from endocrine surgeon. Participants will perform these exercises in a room supervisor physiotherapist.
All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt, 285
- faculty of physical therapy ,Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- They have the development of the shoulder dysfunction (Range of motion limitation and shoulder pain) (limitation of 20 ≥ ROM in shoulder flexion, abduction, external or internal rotation) after thyroidectomy.
- Patients who were 6 months to 1 year post unilateral neck dissection
- Aged 30- 50 years (at the time of surgery)
Exclusion Criteria:
- they had severe cardiac disease, uncontrolled hypertension and upper extremity problems started Before treatment of thyroid cancer surgery.
- Patients with neurological disease, rheumatologically disease, communication problems, recurrent infections, and history of head or neck malignancy, history of > 1 neck dissection, history of bilateral neck dissection,
- open wounds or incision presence in the region and patients proceeding with chemotherapy (CT) or radiotherapy (RT) were barred
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Baduanjin exercises
This group included 40 participants post thyroidectomy; they will receive Baduanjin exercises and conservative shoulder care
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Baduanjin has 8 movement forms, which are relatively less demanding.
Assistive equipment is also not necessary during Baduanjin.
These advantages make Baduanjin a suitable form of exercise training for post thyroidectomy patients.
The movements involved in Baduanjin require the individual to reach beyond the base of support, change the base of support between bilateral and unilateral stance, and perform movements in a sustained squatting posture.
These maneuvers challenge balance and require muscle strength to be executed successfully.
In 8 movement forms of Baduanjin all include shoulder joint function exercises, thus making Baduanjin a potentially useful method for improving activity level and arm strength.
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No Intervention: control group
This group included 40 participants post thyroidectomy; they will receive conservative shoulder care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Pain and disability index (SPADI)
Time Frame: at baseline and at 12 weeks
|
It was used to determine the shoulder pain and disability.
It comprises of 13 items: a 5 item subscale to evaluate the pain and an 8 item subscale to evaluate the disability.
The total score is determined by averaging the pain and disability subscale scores.
The SPADI exhibits great construct validity, associating admirably with other district explicit shoulder questionnaires.
The translated version of the SPADI in the Arabic language showed excellent internal consistency, with a Cronbach's α values of 0.98, and test retest reliability.the
SPADI score ranges from 0 to 100, with higher scores indicating greater shoulder pain and disability
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at baseline and at 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Shoulder range of motion :( active range of motion (ROM)) using Image J
Time Frame: at baseline and at 12 weeks
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The ImageJ, a photograph-based goniometry tool, can measure the angle using images or videos during these exercises.
Measurement method using ImageJ during active ROM exercises.Three-dimensional motion capture systems, such as Vicon, have been widely used with increased accuracy .
However, as these technologies can be costly and are unavailable in many clinical settings , the ImageJ open-source software is considered particularly for measuring the ROM of the upper limbs during exercise
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at baseline and at 12 weeks
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Total calcium concentration
Time Frame: at baseline and at 12 weeks
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at baseline and at 12 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005743
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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