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

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ClinicalTrials.gov Identifier: NCT03302871
Recruitment Status : Recruiting
First Posted : October 5, 2017
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Nigar Dursun, Kocaeli University

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.


Condition or disease Intervention/treatment Phase
Cerebral Palsy Drug: Botulinum toxin type A Device: transcranial direct current stimulation Other: hybrid training model of CIMT and BIT Other: usual care Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Integrated Management With Brain Stimulation and Hybrid Training Enhances Functional Gains in Children With Cerebral Palsy Treated by Botulinum Toxin A
Actual Study Start Date : January 18, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: İntensive Therapy Group
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
Drug: Botulinum toxin type A
Other Name: Botox, Dysport

Device: transcranial direct current stimulation
Other Name: noninvasiv brain stimulation

Other: hybrid training model of CIMT and BIT
Active Comparator: Control Group
Children who received Botulinum toxin type A to plegic upper limb would continue their usual care
Drug: Botulinum toxin type A
Other Name: Botox, Dysport

Other: usual care
Other Name: physical therapy




Primary Outcome Measures :
  1. Assisting Hand Assesment [ Time Frame: 6 weeks ]
    Bilateral Hand Function Evaluation Instrument


Secondary Outcome Measures :
  1. Jebsen Taylor Hand Function Test [ Time Frame: 6 weeks ]
    Unilateral Hand Function Evaluation Instrument


Other Outcome Measures:
  1. Modifed Ashworth Scale [ Time Frame: 6 weeks ]
    Measurement of Tone

  2. Active ROM of wrist dorsiflexion [ Time Frame: 6 weeks ]
    Measurement of active muscle function

  3. Modified Tardieu Scale [ Time Frame: 6 weeks ]
    Measurement of spasticity



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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of unilateral cerebral palsy
  • able to activate wrist and finger flexors
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302871


Contacts
Contact: Nigar Dursun, MD 905334322568 nigard@hotmail.com
Contact: Cigdem Cekmece, PhD 905335483955 cigdemcekmece@yahoo.com

Locations
Turkey
Kocaeli University Recruiting
Kocaeli, Turkey, 41050
Contact: Nigar Dursun, MD    905334322568    nigard@hotmail.com   
Contact: Cigdem Cekmece, PhD    905335483955    cigdemcekmece@yahoo.com   
Sub-Investigator: Begum C Tayyare, PHD student         
Sponsors and Collaborators
Kocaeli University
Investigators
Principal Investigator: Nigar Dursun, MD Kocaeli University

Responsible Party: Nigar Dursun, Professor, MD, Kocaeli University
ClinicalTrials.gov Identifier: NCT03302871     History of Changes
Other Study ID Numbers: KOUKAEK 2016/20
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nigar Dursun, Kocaeli University:
cerebral palsy
botulinum toxin A
constraint induced movement therapy
transcranial direct current stimulation

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents