- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07482735
Effect of Perturbation Exercise Protocol in Patients With Partial Rotator Cuff Tear: A Single-Blind Randomized Controlled Trial
Effects of Perturbation-Based Rehabilitation on Pain, Proprioception, Muscle Strength, Range of Motion and Functional Performance in Patients With Partial Rotator Cuff Tear: A Single-Blind Randomized Controlled Trial
Partial rotator cuff tears negatively affect shoulder stability, proprioception, and neuromuscular control. Perturbation-based rehabilitation has been shown to enhance reflex muscle activation and dynamic joint stabilization; however, randomized controlled studies investigating its effects in patients with partial rotator cuff tears are limited.
This single-blind randomized controlled trial aims to investigate the long-term effects of a perturbation exercise protocol on pain, proprioception, muscle strength, range of motion, and functional performance in individuals with partial rotator cuff tears.
Sixty participants will be randomly assigned to either a conventional physiotherapy group or a perturbation-based rehabilitation group. Outcomes will be assessed at baseline, post-treatment (10 days), and one month follow-up.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Partial rotator cuff tears are common musculoskeletal disorders that negatively affect shoulder stability, neuromuscular control, muscle strength, and functional performance. Damage to mechanoreceptors within the rotator cuff complex may impair proprioceptive feedback and dynamic stabilization, leading to persistent pain and recurrent microtrauma.
Conventional physiotherapy programs primarily focus on pain reduction and strengthening exercises. However, neuromuscular control deficits and proprioceptive impairments may not be fully addressed through traditional rehabilitation approaches. Perturbation-based exercise training has been proposed as a rehabilitation strategy aimed at enhancing reflexive muscle activation, improving co-contraction patterns, and promoting dynamic joint stability through controlled external disturbances.
Although perturbation exercises have shown promising effects in other shoulder pathologies and postoperative populations, randomized controlled trials investigating their long-term effects in individuals with partial rotator cuff tears are limited.
This single-blind randomized controlled trial aims to evaluate the effectiveness of a perturbation-based rehabilitation program in addition to conventional physiotherapy on shoulder muscle strength (primary outcome), pain intensity, range of motion, proprioception, and functional performance. Sixty participants will be randomly assigned to either a control group receiving conventional therapy alone or an experimental group receiving additional perturbation exercises. Outcomes will be assessed at baseline, post-treatment (10 days), and one-month follow-up.
The findings of this study may contribute to evidence-based rehabilitation strategies and help optimize treatment protocols for patients with partial rotator cuff tears.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sivas, Turkey (Türkiye), 58140
- Sivas Cumhuriyet University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-65 years
- Clinically diagnosed partial rotator cuff tear
- Suitable for physiotherapy
- Signed informed consent
Exclusion Criteria:
- Full-thickness rotator cuff tear
- Previous shoulder surgery
- History of fracture or dislocation
- Adhesive capsulitis
- Neurological deficit in upper extremity
- Professional athletes
- Active systemic rheumatologic disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Conventional physiotherapy + perturbation exercise protocol
|
Non
Other Names:
Non
|
|
Other: Control Group
Conventional physiotherapy only
|
Non
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder muscle strength
Time Frame: Baseline, Day 10 (post-treatment), 1 month follow-up
|
Shoulder flexor, abductor, and medial and lateral rotator muscles muscle strength measured by Handheld Dynamometer
|
Baseline, Day 10 (post-treatment), 1 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Range of Motion
Time Frame: Time Frame: Baseline, Day 10 (post-treatment), 1 month follow-up
|
Measuremets for shoulder range of motion (flexion, abduction, and internal and external rotation) with a üniversal goniometer
|
Time Frame: Baseline, Day 10 (post-treatment), 1 month follow-up
|
|
Shoulder Pain
Time Frame: Baseline, Day 10 (post-treatment), 1 month follow-up
|
Measumets for shoulder pain with VAS
|
Baseline, Day 10 (post-treatment), 1 month follow-up
|
|
Proprioception
Time Frame: Baseline, Day 10 (post-treatment), 1 month follow-up
|
The target angle was 90 degrees of shoulder flexion.
Joint repositioning errors for this angle were determined using a universal goniometer.
|
Baseline, Day 10 (post-treatment), 1 month follow-up
|
|
Functional Status
Time Frame: Baseline, Day 10 (post-treatment), 1 month follow-up
|
Functional status of the shoulder was determined using the Constant-Murley Score (CMS).
The total CMS score is 100, comprising 15 for pain, 20 for activities of daily living, 40 for range of motion, and 25 for muscle strength.
An increased CMS score indicates better function.
|
Baseline, Day 10 (post-treatment), 1 month follow-up
|
|
Dynamic balance
Time Frame: Baseline, Day 10 (post-treatment), 1 month follow-up
|
The Upper Quadrant Y Balance Test was used to measure the dynamic balance of the upper extremity.
|
Baseline, Day 10 (post-treatment), 1 month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Selvin Balki, Assoc. prof. Dr, Cumhuriyet University
- Principal Investigator: Ayşe Nur Engindoğan, MSc, Cumhuriyet University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Other Study ID Numbers
- SCU-FTR-SB-06
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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