Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia

NCT02299284 | Completed

• 1 other identifier: 13-219CR
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized control trial to test the efficacy of a new treatment involving intensive home-based bimanual training (Hand-Arm Bimanual Intensive Therapy (HABIT) and intensive home-based functional lower-limb training in children with hemiplegia. The protocols have been developed at TC Columbia University to be child friendly and draw upon the investigators experience since 1998 with intensive movement therapy in children with cerebral palsy. The aim is to promote either the use/coordination of movement of the hands or improve lower-limb balance, strength, and function. Caregivers will be trained at the investigator center and then be asked to do 2 hours per day, 5 days per week, for 9 weeks (90 hours total) of activities with their child in their own home. The activities will be supervised by the investigators team via computer. Participants do NOT need to live in the New York City area, but a one-time weekend visit to the investigators center is required for training. All measurement and treatment is performed in the home. Participants are randomized to receive either HABIT or lower-limb training. If caregivers wish, they may chose to be crossed over at the end of the study and trained to receive the other treatment. PARTICIPATION IS FREE. Please check out the investigators website for more information: http://www.tc.edu/centers/cit/

Conditions

Cerebral Palsy

Keywords

Spastic; Hemiplegia

Outcome Measures

Primary Outcomes (2)

• Assisting Hand Assessment

  measure of bimanual hand-use in spontaneous play setting

  Change from baseline to 9 weeks

• 10 Meter walk test

  measures child's velocity when walking over 10 meters

  Change from baseline to 9 weeks

Secondary Outcomes (2)

• Assisting Hand Assessment

  Change from baseline to 6 months

• 10 Meter walk test

  Change from baseline to 6 months

Study Arms (2)

Hand-Arm Bimanual Intensive Therapy (HABIT)

EXPERIMENTAL

HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab

Other: Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia

Intensive Functional Lower-Limb Training

EXPERIMENTAL

lower-limb function, strength training, balance, PT, OT, rehab

Other: Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia

Interventions

Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia OTHER

Hand-Arm Bimanual Intensive Therapy (HABIT); Intensive Functional Lower-Limb Training

Eligibility Criteria

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

You may qualify if:

• Children between the ages of 2.5 - 12 years with hemiplegia; hemiplegia due to result of prenatal stroke, brain lesion, or malformation (or within the two years of life).
• Children that have the ability to grasp or release objects with the affected hand
• Children who are able to walk independently without the assistance of a device
• Children that have the cognitive capability to follow simple instructions and interact in play activities 2 hours per day with a parent/caregiver.
• Caregivers willing to commit to the entire intervention period of 90 hours over 9 weeks
• Caregivers able to provide one-on-one attention to child during the daily two hours of activities (note: because this is part of a research study, we can only train one caregiver per household)

You may not qualify if:

• Children that have received Botox or are planning any new treatment within 6 mos. of enrollment in the study.

Sponsors & Collaborators

• Teachers College, Columbia University: lead

Study Sites (1)

Teachers College, Columbia University Center for Cerebral Palsy Research

New York, New York, 10027, United States

Location

Related Publications (4)

• Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. doi: 10.1017/S0012162206002039.

  PMID: 17044964 BACKGROUND

• Ferre CL, Brandao MB, Hung YC, Carmel JB, Gordon AM. Feasibility of caregiver-directed home-based hand-arm bimanual intensive training: a brief report. Dev Neurorehabil. 2015 Feb;18(1):69-74. doi: 10.3109/17518423.2014.948641. Epub 2014 Sep 2.

  PMID: 25180530 RESULT

• Gordon AM, Schneider JA, Chinnan A, Charles JR. Efficacy of a hand-arm bimanual intensive therapy (HABIT) in children with hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2007 Nov;49(11):830-8. doi: 10.1111/j.1469-8749.2007.00830.x.

  PMID: 17979861 RESULT

• Surana BK, Ferre CL, Dew AP, Brandao M, Gordon AM, Moreau NG. Effectiveness of Lower-Extremity Functional Training (LIFT) in Young Children With Unilateral Spastic Cerebral Palsy: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2019 Oct;33(10):862-872. doi: 10.1177/1545968319868719. Epub 2019 Aug 22.

  PMID: 31434537 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity; Hemiplegia

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Study Officials

• Andrew Gordon, Ph.D.

  Teachers College, Columbia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 24, 2014
• Study Start: June 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

US (1)