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
Verified date | April 2020 |
Source | Kocaeli University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Kocaeli University | Kocaeli |
Lead Sponsor | Collaborator |
---|---|
Kocaeli University |
Turkey,
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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