Health TrialsbyHealthPanel

tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

ConditionsCerebral PalsyHemiplegic Cerebral PalsySpastic Hemiplegic Cerebral PalsySpastic HemiparesisSpastic Hemiplegia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorBurke Medical Research Institute

About this trial

The goal of this study is to test the efficacy of transcranial direct current stimulation combined with bimanual training on hand function in children with unilateral spastic cerebral palsy (USCP). Children who enroll in the protocol will be randomized to receive either sham (not stimulating) tDCS plus bimanual training, or active (stimulating) tDCS plus bimanual training.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of congenital hemiplegic cerebral palsy

Ability to lift and grasp light objects with affected hand

Ability to extend wrist of affected hand 15 degrees

Ability to follow instructions and provide informed assent

Disqualifiers

Seizures after age 2 years

Spasticity medication within 6 months before study

Selective dorsal rhizotomy

Surgery in affected upper extremity within year before study

Trial design

Design model

Parallel

Treatments tested in this trial

  • active transcranial direct current stimulation

    Device

    Participants will receive 20 min of tDCS over the scalp during the first 20 min of bimanual training.

  • bimanual training

    Behavioral

    Participants will engage in movements that use both hands, by playing with toys and games.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Active tDCS + bimanual trainingExperimental treatment 2 interventions
Group B: Sham tDCS + bimanual trainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Assisting Hand Assessment

Measure of how well the child uses both hands cooperatively for bimanual activities

Time frame
Day before intervention begins, compared to day after intervention ends (six days after intervention begins)

Secondary outcomes

1

Jebsen-Taylor Test of Hand Function

Measure of movement speed of affected hand

Time frame
Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
2

Box and Blocks test

Measure of movement speed of affected hand

Time frame
Day before intervention begins, compared to day after intervention ends (six days after intervention begins)

Other outcomes

Sponsors and contacts

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Burke Medical Research Institute

Lead sponsor

University of Minnesota

Collaborator

Teachers College, Columbia University

Collaborator

Source ClinicalTrials.gov
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