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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302871
• Other study ID #: KOUKAEK 2016/20
• Status: Completed
• Phase: Phase 3
• Start date: January 18, 2016
• Est. completion date: January 30, 2020

Study information

• Verified date: April 2020
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Drug:
• Botulinum toxin type A

Device:
• transcranial direct current stimulation

Other:
• hybrid training model of CIMT and BIT

• usual care

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Modifed Ashworth Scale	Measurement of Tone	6 weeks
Other	Active ROM of wrist dorsiflexion	Measurement of active muscle function	6 weeks
Other	Modified Tardieu Scale	Measurement of spasticity	6 weeks
Primary	Assisting Hand Assesment	Bilateral Hand Function Evaluation Instrument	6 weeks
Secondary	Jebsen Taylor Hand Function Test	Unilateral Hand Function Evaluation Instrument	6 weeks