Constraint-Induced Movement Therapy in a Pediatric Oncology Population

NCT01447810 | Completed

• 1 other identifier: SJCIT
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemiplegia; Brain Tumor

Keywords

Constraint-Induced Movement therapy; Pediatric; Hemiplegia; Brain Tumor; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Number of participants who complete the study.

  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).

  One (1) year

Secondary Outcomes (2)

• Frequency of extremity use.

  Baseline, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 4 months

• Quality of extremity function.

  Baseline, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 4 months

Study Arms (1)

Treatment

EXPERIMENTAL

Other: Focused rigidity bi-valve long arm cast

Interventions

Focused rigidity bi-valve long arm cast OTHER

Two focused rigidity bi-valve long arm (upper arm to finger tips) casts will be fabricated for each participant on day one of the constraint-induced therapy (CIT) program. Focused rigidity casting materials are water proof and latex/fiberglass free. Focused rigidity casting does not require use of a cast saw for removal thus decreasing potential for anxiety during the casting process. Casts will be fabricated by therapist trained in the casting technique.

Also known as: constraint-induced therapy

Treatment

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Hemiplegia; Brain Neoplasms

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Jessica Sparrow, OTD, OTR/L

  St. Jude Children's Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 6, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 14, 2015

Record last verified: 2014-09

Locations

US (1)