Clinical trial NCT04166279: The Recovery of Reaching Movement in Breast Cancer Survivors: Two Different Rehabilitative Protocols in Comparison
Official title: The Recovery of Reaching Movement in Breast Cancer Survivors: Two Different Rehabilitative Protocols in Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Cancer Lymphedema
Pain
Pain, Postoperative
Pain, Chronic
Mastectomy; Lymphedema
Breast Surgery
Keywords: Breast Cancer
Pain Chronic and Postoperative
Lymphedema
Posture
Target - Reaching movement
Breast surgery
Functional impotence
Rehabilitive treatment
Physiotherapy
Scapula tilting
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Breast cancer (BC) is the most common cancer in women in the developed world. Surgery and medical protocols have improved significantly over the last 10 years and this guarantees a better chance of survival and an improvement in quality of life.

Then, the focus on "what happen after defeating BC" has become current: patients' and physicians' awareness of the sequelae of BC surgery has increased, especially in the case of mastectomy or modified radical mastectomy. A large number of these complications, such as lymphedema or post-treatment pain with or without functional impotence, which contribute to limitations in daily life activities, can be treated favourably and, in sometimes, resolved with early rehabilitation protocols. Therefore, it is not only important to start the rehabilitation process early after surgery, but, also, during the sub-acute phase, choose appropriate exercise programs to allow recovery in "quantity" and "quality" of the movement of the operated upper limb (UL). Alterations in muscle activation and reduced shoulder mobility are common in patients with BC. It is necessary to consider that winged scapula incidence in BC surgery is 8% and the prevalence decreased during 6 months after surgery. In particular, patients who developed winged scapula had more shoulder flexion, adduction and abduction limitation. These findings suggest that, after BC surgery, soft tissues restrictions obstruct short-term scapula motion.

Reaching movement is a complex multi-articular movement towards a defined point in space and allows the hand to interact with the environment. Nevertheless, it is not yet investigated during the rehabilitation process. Moreover, the execution of the UL movements, improves if the numerous perturbations of the musculoskeletal system, which occur during the execution of movements, are compensated. Motor synergy's components should modify their action to influence positively the outcome of motor activity, preventing the mistakes of the individual components from influencing the overall activity. An important issue is represented by the redundancy of the degrees of motor freedom. Actions and movements can be performed in different ways because the functional synergies are able to co-vary, without changing the result of the action. However, only three spatial dimensions are needed to specify any position where the hand could be placed. This excess of kinematic degrees of freedom means that there are multiple arm configurations that correspond to any particular position of the hand. Thus, improvements in reaching, after BC mastectomy, can be determined, compared to a different rehabilitation protocol, by comparing the Single rehabilitative Treatment (ST) with Group Treatment (GT). Authors designed a randomized-controlled trial to check if specific scapula exercises, included in the ST, could induce changes in the fluidity of the reaching, called Jerk (primary outcome), decrease shoulder pain and improve the functioning of the operated upper limb (secondary outcomes).

Eligibility criteria: 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

Primary outcomes:
measure: Change [over time] of the normalized jerk (NJ) within biomechanical reaching movement
timeFrame: T0 baseline - T1 (6 weeks) - T2 (3 months)
Secondary outcomes:
measure: Change [over time] of Visual Analogue Scale (VAS)
timeFrame: T0 baseline - T1 (6 weeks) - T2 (3 months)
measure: Change [over time] of Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)
timeFrame: T0 baseline - T1 (6 weeks) - T2 (3 months)
measure: Change [over time] of Movement Duration (MD) of biomechanical reaching movement
timeFrame: T0 baseline - T1 (6 weeks) - T2 (3 months)
measure: Change [over time] of the angle of arm flexion at end of movement (AAF) within biomechanical reaching movement
timeFrame: T0 baseline - T1 (6 weeks) - T2 (3 months)
measure: Change [over time] of the angle at elbow at end of movement (AE) within biomechanical reaching movement
timeFrame: T0 baseline - T1 (6 weeks) - T2 (3 months)
measure: Change [over time] of the mean value of target-approaching velocity (TAV) within biomechanical reaching movement
timeFrame: T0 baseline - T1 (6 weeks) - T2 (3 months)
Other outcomes:
measure: Change [over time] of range of Motion (ROM) of shoulder
timeFrame: T0 baseline - T1 (6 weeks) - T2 (3 months)
Locations:
city: Rome
country: Italy
facility: Umberto I Hospital
Study officials:
References: