Integrated Management Enhances Functional Gains in Children With Cerebral Palsy Treated by BoNT-A

Integrated Management With Brain Stimulation and Hybrid Training Enhances Functional Gains in Children With Cerebral Palsy Treated by Botulinum Toxin A

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03302871

Enrollment

Registered

2017-10-05

Start date

2016-01-18

Completion date

2020-01-30

Last updated

2020-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

cerebral palsy, botulinum toxin A, constraint induced movement therapy, transcranial direct current stimulation

Brief summary

Evidence from literature support the use of Botulinum toxin A (BoNT-A) for upper limb spasticity management in children with cerebral palsy (CP). Constraint Induced Movement Therapy (CIMT) and Bilateral Intensive Training (BIT) are indicated as effective and complimentary treatments to improve motor function in these children. In a recent trial combined noninvasiv brain stimulation and CIMT enhanced therapy induced functional gains. In this clinical trial the aim was to evaluate the effects of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT when integrated with BoNT-A treatment in children with unilateral CP.

Detailed description

Although BoNT-A is effective in spasticity management there is inconclusive evidence to support its usage for improvement in upper limb activity and function. Combination of BoNT-A and occupational therapy (OT) is found to be more effective then OT alone in reducing impairment, improving activity level and goal achievement. Intensive hybrid training models of CIMT and BIT and noninvasive brain stimulation are promising treatments on motor learning in children with CP. The aim of this clinical trial is to show the additional gains that could be provided by an integrated treatment of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT to BoNT-A injections in children with unilateral CP.

Interventions

DRUGBotulinum toxin type A

DEVICEtranscranial direct current stimulation

OTHERhybrid training model of CIMT and BIT

OTHERusual care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

5 Years to 16 Years

Healthy volunteers

Inclusion criteria

* diagnosis of unilateral cerebral palsy * able to activate wrist and finger extensors * being scheduled for BoNT-A treatment for upper limb

Exclusion criteria

* significant loss of wrist and or fingers * history of orthopedic surgery to plegic upper limb

Design outcomes

Primary

Measure	Time frame	Description
Assisting Hand Assesment	6 weeks	Bilateral Hand Function Evaluation Instrument

Secondary

Measure	Time frame	Description
Jebsen Taylor Hand Function Test	6 weeks	Unilateral Hand Function Evaluation Instrument

Other

Measure	Time frame	Description
Modifed Ashworth Scale	6 weeks	Measurement of Tone
Active ROM of wrist dorsiflexion	6 weeks	Measurement of active muscle function
Modified Tardieu Scale	6 weeks	Measurement of spasticity

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026