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Constraint Induced Movement Therapy in a Pediatric Oncology Population (SJCIT): A Pilot Study


N/A
2 Years
12 Years
Open (Enrolling)
Both
Hemiplegia, Brain Tumor

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Trial Information

Constraint Induced Movement Therapy in a Pediatric Oncology Population (SJCIT): A Pilot Study


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. Overtime, 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 nonuse" 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 nonuse, 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.


Inclusion Criteria:



- Diagnosed hemiplegia of an upper extremity as documented by physician or
rehabilitation clinician in the medical record

- Diagnosis of brain tumor

- English speaking

- Participant has demonstrated the ability in the past to move the elbow >70 degrees
and has some purposeful movement in the hand (ability to initiate a gross grasp).

- Parent/legal guardian is willing to give consent to participate in the study.

- Child is willing to give assent in the study if seven years old or older.

Exclusion Criteria:

- Severe hemiplegia and resulting active range of motion deficits at the affected upper
extremity as defined by the following:

- < 30 degrees active shoulder flexion or abduction

- Inability to initiate active elbow flexion or extension.

- Inability to initiate movements at the of wrist, finger or thumb

- Uncontrolled seizures that interfere with daily activities, as this would interfere
with the participant's ability to fully participate in the CI Therapy program.

- Pain that significantly interferes with the participant's ability to fully
participate in the intensive therapy program. This includes pain related to
subluxation of the shoulder, as measured by a pain rating of 5/10 or greater on the
FACES or Numeric Pain Scale.

- Currently receiving oral or intravenous chemotherapy or radiation therapy.

- Inability or unwillingness of legal guardian to give written informed consent.

- Child is unwilling to give assent if seven years old or older.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Number of participants who complete the study.

Outcome Description:

To evaluate the feasibility of conducting a 3-week constraint-induced therapy program in patients with upper extremity hemiplegia as a result of a tumor. We will conclude that conducting this constraint induced therapy program is not feasible if more than 2 patients out of eight patients do not complete the program for any reason, with exception those outlined as excused reasons for absence from a therapy sessions (acute illness of the participant, illness of a parent, or other interruptions considered allowable/unavoidable by the study PI).

Outcome Time Frame:

One (1) year

Safety Issue:

No

Principal Investigator

Jessica Sparrow, OTD, OTR/L

Investigator Role:

Study Chair

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

SJCIT

NCT ID:

NCT01447810

Start Date:

October 2011

Completion Date:

October 2013

Related Keywords:

  • Hemiplegia
  • Brain Tumor
  • Constraint-Induced Movement therapy
  • Pediatric
  • Hemiplegia
  • Brain Tumor
  • Rehabilitation
  • Brain Neoplasms
  • Hemiplegia

Name

Location

St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794