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

Kocaeli University

Status and phase: Completed; Phase 3

Conditions: Cerebral Palsy

Treatments: Drug: Botulinum toxin type A; Other: usual care; Other: hybrid training model of CIMT and BIT; Device: transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03302871

KOUKAEK 2016/20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

İntensive Therapy Group

Experimental group

Description:

Children who received Botulinum toxin type A to plegic upper limb would be treated by transcranial direct current stimulation and a hybrid training model of CIMT and BIT

Treatment:

Device: transcranial direct current stimulation

Other: hybrid training model of CIMT and BIT

Drug: Botulinum toxin type A

Control Group

Active Comparator group

Description:

Children who received Botulinum toxin type A to plegic upper limb would continue their usual care

Treatment:

Other: usual care

Drug: Botulinum toxin type A