The Recovery of Reaching Movement in Breast Cancer Survivors: Two Different Rehabilitative Protocols in Comparison
The Recovery of Reaching Movement in Breast Cancer Survivors: Two Different Rehabilitative Protocols in Comparison
Sponsors
Source
University of Roma La Sapienza
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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).
Overall Status
Completed
Start Date
2018-01-08
Completion Date
2019-07-19
Primary Completion Date
2019-04-15
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Change [over time] of the normalized jerk (NJ) within biomechanical reaching movement |
T0 baseline - T1 (6 weeks) - T2 (3 months) |
Secondary Outcome
Measure |
Time Frame |
|
Change [over time] of Visual Analogue Scale (VAS) |
T0 baseline - T1 (6 weeks) - T2 (3 months) |
|
Change [over time] of Disabilities of Arm, Shoulder and Hand Questionnaire (DASH) |
T0 baseline - T1 (6 weeks) - T2 (3 months) |
|
Change [over time] of Movement Duration (MD) of biomechanical reaching movement |
T0 baseline - T1 (6 weeks) - T2 (3 months) |
|
Change [over time] of the angle of arm flexion at end of movement (AAF) within biomechanical reaching movement |
T0 baseline - T1 (6 weeks) - T2 (3 months) |
|
Change [over time] of the angle at elbow at end of movement (AE) within biomechanical reaching movement |
T0 baseline - T1 (6 weeks) - T2 (3 months) |
|
Change [over time] of the mean value of target-approaching velocity (TAV) within biomechanical reaching movement |
T0 baseline - T1 (6 weeks) - T2 (3 months) |
Enrollment
66
Conditions
Intervention
Intervention Type
Other
Intervention Name
Description
The rehabilitation treatment, performed by a physiotherapist trained in oncological rehabilitation, was carried out with a 6-week exercise program for 12 sessions (60 minutes/session, 2/week).). The protocol included a first phase consist in low impact aerobics warming (15-20 minutes), then diaphragmatic breathing and postural exercises for the midline alignment. The awareness of abdominal breathing represents the preliminary phase for a complete psychophysical relaxation of the patient, an important prerequisite for the correct execution of subsequent mobility, stretching and strengthening exercises of spine, scapula and upper limb. Subsequently, isometric strengthening exercises for shoulder stabilizing muscles, first passively and, subsequently, with supervision, were performed. Specific exercises, for passive mobilization and stabilization of the scapula, cervical pumping and stretching of the pectoral muscles, have been performed.
Arm Group Label
Single rehabilitative Treatment
Intervention Type
Other
Intervention Name
Description
Four-five patients for group. The rehabilitation treatment, performed by a physiotherapist trained in oncological rehabilitation, was carried out with a 6-week exercise program for 12 sessions (60 minutes/session, 2/week). The protocol included at first week mainly breathing techniques, then we introduced exercises gradually more active, according to the improvements of the execution. The exercises had the aim to improve the opening of the scapular chain and to increase the amplitude of the range of motion in order to stimulate better neuromuscular control during the movement of scapular retropulsion, to stretch the pectoral muscles following the rhythm of the breath and the tissues affected by post-surgical scars and fibrotic effects, finally to reinforcing, against gravity, the musculature of the shoulders and back.
Arm Group Label
Group rehabilitative Treatment
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
Gender
Female
Minimum Age
18 Years
Maximum Age
60 Years
Healthy Volunteers
Accepts Healthy Volunteers
Location
Facility |
|
Umberto I Hospital Rome 00165 Italy |
Location Countries
Country
Italy
Verification Date
2019-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
University of Roma La Sapienza
Investigator Full Name
Teresa Paolucci
Investigator Title
Medical Doctor, PhD
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Single rehabilitative Treatment
Arm Group Type
Experimental
Description
Patients treated within single rehabilitative protocol
Arm Group Label
Group rehabilitative Treatment
Arm Group Type
Experimental
Description
Patients treated within group rehabilitative protocol
Firstreceived Results Date
N/A
Other Outcome
Measure
Change [over time] of range of Motion (ROM) of shoulder
Time Frame
T0 baseline - T1 (6 weeks) - T2 (3 months)
Description
The degrees of flexion, extension, adduction, abduction and internal and external rotation evaluated on the side underwent surgery.
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
November 13, 2019
Study First Submitted Qc
November 13, 2019
Study First Posted
November 18, 2019
Last Update Submitted
November 17, 2019
Last Update Submitted Qc
November 17, 2019
Last Update Posted
November 19, 2019
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.