Skip to main content
OpenTrials
Completed

NCT Number: NCT02918890

Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia

A randomized control trial examining the relationship between changes in hand function and brain plasticity following intensive therapy. Two treatment approaches are used: constraint-induced movement therapy (CIMT) or Hand-Arm Bimanual Intensive Therapy (HABIT). The protocols have been developed at TC Columbia University to be child friendly and draw upon our extensive experience with constraint-induced movement therapy in children with cerebral palsy. Our center has been providing interventions camps for children with cerebral palsy since 1998. The interventions are performed in a 15 day day-camp setting with several children and at least one interventionist per child. The aim of the intervention is to improve the use of the affected hand and quality of overall movement in a fun, social setting. PARTICIPATION IS FREE. Please check out our website for more information: http://www.tc.edu/centers/cit/

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cerebral Palsy Behavior Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Children Habits Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Teachers College, Columbia University Center for Cerebral Palsy Research

New York, 10027, United States

About this study

Constraint-induced Movement Therapy and Bimanual training are motor-learning based approaches to engage children in fun activities. This study looks at what areas of the brain are responsible for recovery after intensive training. We are trying to understand how the brain responds to movement training and hope that in the future we can develop new treatments for hemiplegia based on what we learn about the brain in this study.

To study the areas of the brain we will use Magnetic Resonance Imaging (MRI) to take pictures of the brain and Transcranial Magnetic Stimulation (TMS) to determine parts of the brain involved in using the hand. TMS uses a brief magnetic field over the scalp by using a wand that looks like a figure 8. The wand can make brief magnetic fields over a series of spots on your child's head to activate the brain cells under the wand. Non-invasive, single pulse TMS will be used in this study, which is considered minimal risk and tolerable to children. If your child has a recurrent history of seizures after two years of age, he/she might not qualify.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of unilateral cerebral palsy

Exclusion criteria

  • Current medical illness unrelated to CP
  • Seizure disorder
  • Current use of medications know to lower the seizure threshold
  • Metallic object(s) in body, other than dental fillings
  • Pregnancy
  • Claustrophobia

Treatment and study plan

Constraint-induced movement therapy

Other

Hand-arm Bimanual Intensive Therapy

Other

Primary outcomes

  1. Jebsen-Taylor Test of Hand Function

    Time frame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)

    The JTTHF measures the time taken to complete six unimanual tasks, which include flipping cards, moving small objects, and lifting cans. The total score is the amount of time taken (in seconds) to complete all tasks. A lower score means a better outcome.

  2. Assisting Hand Assessment

    Time frame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)

    The AHA is a validated test for measuring bimanual hand use in children with UE impairments. The AHA measures the use of the more affected hand in bimanual activities during a play-like testing session. Sessions were videotaped and scored off-site by a blinded evaluator. The AHA has excellent validity, reliability (0.97-0.99) and responsiveness to change. The AHA units were used for the analysis (range 0-100). The smallest detectable difference (SDD) for AHA is an improvement of at least 5 units. A higher score means a better outcome.

  3. Box and Blocks Test

    Time frame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)

    The BBT measures how many blocks (2.5 cm3) an individual can move from one box, over a barrier, to an adjacent box in 1 min. Both hands were tested. The BBT is valid and reliable for children with CP. A higher score means a better outcome.

Secondary outcomes

  1. Canadian Occupational Performance Measure

    Time frame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)

    The COPM is a structured interview in which the individuals are asked to identify up to five functional goals. In this study, parents reported their child's functional goals. Parents rated how well children perform each goal (COPM-Performance), and how satisfied they were with the child's performance (COPM-Satisfaction). The same caregiver was interviewed before and after the intervention. A change of 2 or more points in each scale of COPM is considered a minimum clinically important difference (MCID). The COPM has been validated for parents of children with disabilities. A high score means a better outcome (range 0-10).

Sponsors and collaborators

Lead sponsor

Teachers College, Columbia University

Other

Collaborators

  • Burke Medical Research Institute

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Sep 29, 2016
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.