Brain Tumor Clinical Trial
Official title:
Constraint Induced Movement Therapy in a Pediatric Oncology Population (SJCIT): A Pilot Study
Hemiplegia (weakness or poor muscle function on one side of the body) is a neurological
impairment which can occur in children as a result of a brain tumor or related treatment.
This impairment can negatively impact the child's functional abilities and movement
development, making it difficult for them to play, learn to feed, dress or bathe themselves,
and to participate fully in home, daycare, or school environments. Poor movement skills may
also impact overall quality of life. Constraint Induced Therapy is a rehabilitation
technique which has been found to improve the child's abilities to move their arms following
neurological injuries like stroke and traumatic brain injury in both adults and children.
The aim of this study is to evaluate the feasibility of implementing a constraint induced
movement therapy program in a small group of children with a brain tumor and hemiplegia.
Children who participate in the program may experience improved ability to use their weak
arm leading to increased participation in meaningful activity and improved quality of life.
Constraint Induced Therapy (CI Therapy) is based on the theory of "learned non-use."
Following an event that impacts the brain (stroke, brain injury etc.), the messages from the
brain to the arm and the messages from the arm to the brain are interrupted in the area of
the brain where the injury occurred and in a small surrounding area. The arm is often
inefficient and difficult to use. Over time, even after swelling in the brain decreases,
movement of the affected arm continues to be more effortful and the child becomes quite
accustomed to completing activities with the unaffected arm only. Additionally, because the
child has not used the weak arm for a while, the part of the brain that is ready to receive
signals and give commands to the arm or leg is "quiet" and does not work like it used to.
The theory of "learned no-nuse" has lead to the development of the CI Therapy approach which
is comprised of the following principles:
- Constraint - the strong or normal arm/leg is restrained, forcing use of the weaker
arm/leg during treatment.
- Practiced Use - the weak limb is treated by engaging the child in structured practice
of specific movements and functional skills.
- Transfer Package - a home program is developed for the child to use with his or her
caregivers that focuses on facilitating carryover of learned skills into the real world
environment.
This theory hypothesizes that, because the nervous system, particularly in the child, has
plasticity (can be shaped and learn to do new things), CI Therapy will facilitate cortical
(brain) reorganization, and help the child overcome learned non-use, eventually leading to
improved function of the weak arm or leg.
Phase 1: Initial evaluations will be completed on day 1 of the program. They include
interview questions and direct assessment of the participant's ability to use the affected
arm as well as to participate in meaningful age-appropriate activities. These assessments
include the Motor Activity Log, The Pediatric Arm Function Test, the Inventory of New Motor
Activities and Programs, the Pediatric Quality of Life Inventory, and the Preschool Activity
Card Sort or Children's Assessment of Activity Preferences.
Phase 2: The participant completes an intensive occupational therapy program which consists
of 15 three-hour therapy sessions (5 days per week for 3 weeks). Throughout the three week
program the un-involved arm will be constrained with a removable cast. The cast is to be
worn 24 hours per day throughout the 3 week program with the exception of regularly
scheduled cast changes, washings and skin checks completed by the treating occupational
therapist. During the direct intervention sessions, a focus of therapy is on facilitation of
new motor skills for the affected arm. Play is utilized as a means to motivate the pediatric
participants with activities and exercises specifically chosen to facilitate new motor
skills. The program also includes a variety of tools and activities caregivers will complete
increasing adherence to the program outside of the direct intervention sessions and to
facilitate transfer of affected upper extremity use into the real world environment.
Phase 3: Immediately following the 3 week intervention program the participant's performance
is re-assessed. Additionally weekly follow up evaluations are completed by phone for a
period of one month. Three months following the intervention program the participant will
return for follow up evaluations.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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