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

Sponsor
Kocaeli University (Other)
Overall Status
Completed
CT.gov ID
NCT03302871
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
48.4
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Interventional
Actual Enrollment :
40 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 :
Jan 18, 2016
Actual Primary Completion Date :
Jan 30, 2020
Actual Study Completion Date :
Jan 30, 2020

Arms and Interventions

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 Names:
  • Botox, Dysport

    • Device: transcranial direct current stimulation
    Other Names:
  • 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 Names:
  • Botox, Dysport

    • Other: usual care
    Other Names:
  • physical therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assisting Hand Assesment [6 weeks]

      Bilateral Hand Function Evaluation Instrument

    Secondary Outcome Measures

    1. Jebsen Taylor Hand Function Test [6 weeks]

      Unilateral Hand Function Evaluation Instrument

    Other Outcome Measures

    1. Modifed Ashworth Scale [6 weeks]

      Measurement of Tone

    2. Active ROM of wrist dorsiflexion [6 weeks]

      Measurement of active muscle function

    3. Modified Tardieu Scale [6 weeks]

      Measurement of spasticity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kocaeli University Kocaeli Turkey 41050

    Sponsors and Collaborators

    • Kocaeli University

    Investigators

    • Principal Investigator: Nigar Dursun, MD, Kocaeli University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nigar Dursun, Professor, MD, Kocaeli University
    ClinicalTrials.gov Identifier:
    NCT03302871
    Other Study ID Numbers:
    • KOUKAEK 2016/20
    First Posted:
    Oct 5, 2017
    Last Update Posted:
    Apr 24, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    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, Professor, MD, Kocaeli University
    cerebral palsy
    botulinum toxin A
    constraint induced movement therapy
    transcranial direct current stimulation
    Additional relevant MeSH terms:
    Paralysis
    Cerebral Palsy
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Apr 24, 2020