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Clinical Trials/NCT04421807
NCT04421807
Unknown
Not Applicable

Investigation of the Effects of Scapulathoracic Stabilization Exercises Additionally Applied to Complex Decongestive Therapy After Mastectomy on Posture, Balance and Quality of Life

Ataturk Training and Research Hospital1 site in 1 country30 target enrollmentMay 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lymphedema
Sponsor
Ataturk Training and Research Hospital
Enrollment
30
Locations
1
Primary Endpoint
Thoracic khyphosis
Last Updated
5 years ago

Overview

Brief Summary

The aim of the study is to investigate the effects of scapulathoracic stabilization exercises additionally applied to complex decongestive therapy after mastectomy on posture, balance and quality of life.

Detailed Description

Lymphedema is a chronic and progressive condition that occurs with the accumulation of protein-rich fluid in interstitial tissue spaces as a result of abnormal development or damage to the lymphatic system. Lymphedema is divided into 2 as primary and secondary. Secondary lymphedema is the most common form seen in upper extremity, usually after breast cancer treatment approaches. In lymphedema, not only upper limb affected, but also posture, balance, shoulder girdle, scapula and quality of life can be adversely affected. Complex decongestive therapy has been accepted as the gold standard treatment in lymphedema to reduce edema, however, there were insufficient studies investigating the effects on the posture and the balance in patients with lymphedema. Scapulatoracic stabilization exercises aim to increase muscle stability ability, kinesthetic awareness, ovarall stability and balance. However, when the literature is reviewed, no study is found investigating the effect of scapulatoracic stabilization exercises in individuals who developed lymphedema after mastectomy.

Registry
clinicaltrials.gov
Start Date
May 20, 2020
End Date
June 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Ataturk Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Seyda TOPRAK CELENAY

Associate Professor

Ataturk Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • 18 to 65 years of age
  • Agree to participate in the study,
  • Undergoing unilateral mastectomy due to breast cancer treatment and additionally development of limb lymphedema,
  • Lymphedema stage 2 and 3,
  • Being a woman,
  • Having spent at least 6 months after the operation
  • With or without radiotherapy and / or chemotherapy.

Exclusion Criteria

  • Irregular participation to the treatment program,
  • Severe heart failure and / or rhythm disturbance,
  • Uncontrolled hypertension,
  • Presence of metastasis,
  • Infection in the affected arm,
  • Any problems that may affect balance (rheumatological, vestibular, visual, neurological),
  • Muscular and skeletal system problems (limb shortness, ankle sprain ...), which may affect the balance and posture negatively.
  • Presence of spinal deformity,
  • Those who have had spinal surgery in the last 6 months.

Outcomes

Primary Outcomes

Thoracic khyphosis

Time Frame: change from baseline , at 4 weeks and at 8 weeks

Thoracic Kyphosis will be evaluated with digital inclinometer device (Baseline® Digital İnclinometer).

Posture angle

Time Frame: change from baseline , at 4 weeks and at 8 weeks

Posture angle will be evaluated with the PostureScreen Mobile (HuaweiTechnologies Co. Ltd, FIG-LX1, Android) application installed on a smartphone

General posture status

Time Frame: change from baseline , at 4 weeks and at 8 weeks

General posture status will be evaluated with the New York Posture Scale, postural changes that can occur in 13 different parts of the body are scored by observing the individual posteriorly and laterally. Each parameter is given 5 if smooth, 3 if moderately impaired, 1 if severely impaired. At the end of the scoring minimum 13, maximum 65 points can be obtained.

Secondary Outcomes

  • The severity of the lymphoedema(change from baseline , at 4 weeks and at 8 weeks)
  • Balance(change from baseline , at 4 weeks and at 8 weeks)
  • Quality of life outcomes(change from baseline , at 4 weeks and at 8 weeks)
  • Lymphedema symptoms(change from baseline , at 4 weeks and at 8 weeks)
  • Range of motion of shoulder(change from baseline , at 4 weeks and at 8 weeks)
  • Scapulatoracic muscle strength(change from baseline , at 4 weeks and at 8 weeks)
  • Scapular dyskinesia(change from baseline , at 4 weeks and at 8 weeks)
  • Upper extremity functions(change from baseline , at 4 weeks and at 8 weeks)

Study Sites (1)

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