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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03302871
Other study ID # KOUKAEK 2016/20
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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