Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07478718
Eligibility Criteria:
Inclusion Criteria:
* Participants must meet all of the following criteria:
1. Female adults between 30 and 65 years old.
2. History of unilateral breast cancer managed with either:
* Modified radical mastectomy, or
* Breast-conserving surgery with axillary clearance.
3. Postoperative interval between 4 and 12 weeks before enrollment.
4. Objective evidence of impaired shoulder mobility or function including:
* Reduction of ROM ≥ 15% compared to the contralateral side,
* VAS pain ≥ 3/10 during shoulder movement, or
* DASH functional score \> 25.
5. Ability to ambulate independently and follow therapist instructions.
6. Willingness to commit to the full rehabilitation protocol for 8 weeks.
Exclusion Criteria:
* Participants will be excluded if they have:
* Previously diagnosed shoulder disorders (adhesive capsulitis, rotator cuff tear, fracture/dislocation).
* Active or untreated lymphedema Grade II-III.
* Ongoing chemotherapy-induced neuropathy causing shoulder dysfunction.
* History of neurological or rheumatological disorders affecting the upper limb.
* Metastatic disease or local recurrence.
* Recent infection, seroma, or unhealed surgical wounds.
* Participation in another physical therapy or exercise program in the past 4 weeks.
* Cognitive impairment or psychiatric conditions interfering with adherence.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT07478718
Study Brief:
Protocol Section:
NCT07478718