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

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Phase 3

Locations

Turkey

Study Type

Interventional

Intervention

Botulinum toxin type A

transcranial direct current stimulation

hybrid training model of CIMT and BIT

usual care

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, botulinum toxin A, constraint induced movement therapy, transcranial direct current stimulation

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

Kocaeli University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

İntensive Therapy Group

Control Group

Arm 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

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

Outcomes

Primary Outcome Measures

Assisting Hand Assesment

Bilateral Hand Function Evaluation Instrument

Secondary Outcome Measures

Jebsen Taylor Hand Function Test

Unilateral Hand Function Evaluation Instrument

Full Information

NCT ID

NCT03302871

First Posted

October 2, 2017

Last Updated

April 22, 2020

Sponsor

Kirsehir Ahi Evran University

1. Study Identification

Unique Protocol Identification Number

NCT03302871

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

January 18, 2016 (Actual)

Primary Completion Date

January 30, 2020 (Actual)

Study Completion Date

January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

İntensive Therapy Group

Arm Type

Experimental

Arm 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

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Botulinum toxin type A

Other Intervention Name(s)

Botox, Dysport

Intervention Type

Device

Intervention Name(s)

transcranial direct current stimulation

Other Intervention Name(s)

noninvasiv brain stimulation

Intervention Type

Other

Intervention Name(s)

hybrid training model of CIMT and BIT

Intervention Type

Other

Intervention Name(s)

usual care

Other Intervention Name(s)

physical therapy

Primary Outcome Measure Information:

Title

Assisting Hand Assesment

Description

Bilateral Hand Function Evaluation Instrument

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Jebsen Taylor Hand Function Test

Description

Unilateral Hand Function Evaluation Instrument

Time Frame

6 weeks

Other Pre-specified Outcome Measures:

Title

Modifed Ashworth Scale

Description

Measurement of Tone

Time Frame

6 weeks

Title

Active ROM of wrist dorsiflexion

Description

Measurement of active muscle function

Time Frame

6 weeks

Title

Modified Tardieu Scale

Description

Measurement of spasticity

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nigar Dursun, MD

Organizational Affiliation

Kirsehir Ahi Evran University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kocaeli University

City

Kocaeli

ZIP/Postal Code

41050

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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