Breast Cancer Clinical Trial
Official title:
The Recovery of Reaching Movement in Breast Cancer Survivors: Two Different Rehabilitative Protocols in Comparison
Verified date | November 2019 |
Source | University of Roma La Sapienza |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study emphasizes the importance of rehabilitation in breast cancer survivors after mastectomy, even during the course of radiotherapy and chemotherapy, both for good efficacy in reducing pain and for functional recovery of the upper limb. Authors designed a randomized-controlled trial to compare two different rehabilitation protocols: the single rehabilitative treatment (ST) and the group treatment (GT). The study is the first attempt to measure the reaching movement after BC surgery with an optoelectronic evaluation system previously standardized in the neurological field during rehabilitation treatment.
Status | Completed |
Enrollment | 66 |
Est. completion date | July 19, 2019 |
Est. primary completion date | April 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - total mastectomy carried out 12 months prior to recruitment for rehabilitation with breast prostheses or tissue expanders performed - age from 18 to 60 years - body mass index (BMI) < 30 - no cognitive dysfunctions ( Mini Mental State Examination MMSE > 24) Exclusion Criteria: - presence of lymphangitis or mastitis - presence of metastasis - surgical complications - neurological deficits - shoulder joint problems before surgery - severe-moderate lymphedema and web axillary syndrome - visual problem not corrected by lenses |
Country | Name | City | State |
---|---|---|---|
Italy | Umberto I Hospital | Rome |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change [over time] of range of Motion (ROM) of shoulder | The degrees of flexion, extension, adduction, abduction and internal and external rotation evaluated on the side underwent surgery. | T0 baseline - T1 (6 weeks) - T2 (3 months) | |
Primary | Change [over time] of the normalized jerk (NJ) within biomechanical reaching movement | The normalized jerk (NJ) was evaluated through the Smart D500 stereo-photogrammetric system (BTS, Italy), calculated on the wrist-target marker distance, within the reaching task performed on the side underwent surgery. It measures the fluidity of the upper limb movement. | T0 baseline - T1 (6 weeks) - T2 (3 months) | |
Secondary | Change [over time] of Visual Analogue Scale (VAS) | Instrument to assess unidimensional measure of pain intensity. VAS was presented in a coloured scale with a middle point, graduations and numbers. Under the scale there was a straight horizontal line of fixed length, 100 mm. The ends were defined as the limits of the parameter to be measured (pain in the last 24 hours), orientated from the left (worst, no pain) to the right (best, worst pain to be imagined). The score is determined by measuring the distance (cm) on the 10 cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. | T0 baseline - T1 (6 weeks) - T2 (3 months) | |
Secondary | Change [over time] of Disabilities of Arm, Shoulder and Hand Questionnaire (DASH) | Self-administered region-specific outcome instrument developed as a measure of self-rated upper-limb disability and symptoms, actually used to monitor changes in symptoms and function over time. It consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. The items are related to the degree of difficulty in performing various functional activities because of arm, shoulder or hand limitations (21 items), the intensity of pain, activityrelated pain, tingling, weakness and stiffness (5 items), and the effect related to social activities, job, sleep and its psychological impact (4 items). | T0 baseline - T1 (6 weeks) - T2 (3 months) | |
Secondary | Change [over time] of Movement Duration (MD) of biomechanical reaching movement | The movement duration (MD) was evaluated in seconds, through the Smart D500 stereo-photogrammetric system (BTS, Italy), within the reaching task performed on the side underwent surgery. | T0 baseline - T1 (6 weeks) - T2 (3 months) | |
Secondary | Change [over time] of the angle of arm flexion at end of movement (AAF) within biomechanical reaching movement | The degrees of the angle of arm flexion at end of movement (AAF) were evaluated through the Smart D500 stereophotogrammetric system (BTS, Italy), within the reaching task performed on the side underwent surgery. A zero value is conventionally assigned to AAF when the arm is along the side, positive values represent flexion, negative ones represent extension. | T0 baseline - T1 (6 weeks) - T2 (3 months) | |
Secondary | Change [over time] of the angle at elbow at end of movement (AE) within biomechanical reaching movement | The degrees of the angle at elbow at end of movement (AE) were evaluated through the Smart D500 stereophotogrammetric system (BTS, Italy), within the reaching task performed on the side underwent surgery. The value assigned is zero when the elbow is completely extended, positive values correspond to flexion, and negative ones to hyperextension. | T0 baseline - T1 (6 weeks) - T2 (3 months) | |
Secondary | Change [over time] of the mean value of target-approaching velocity (TAV) within biomechanical reaching movement | The mean value of target-approaching velocity (TAV) was evaluated through the Smart D500 stereo-photogrammetric system (BTS, Italy), within the reaching task performed on the side underwent surgery. | T0 baseline - T1 (6 weeks) - T2 (3 months) |
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