Comparative Efficacy Research of Intensive and Distributed Constraint-Induced Therapy: Evidence-Based Neurorehabilitation in Children With CP

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This 3-year research project aims to investigate and compare the treatment effectiveness (in terms of motor and psychosocial outcomes) and potential predictors (in terms of demographical, biological and psychosocial domains) of the intensive and distributed Child- and Family-Friendly CIT protocols with an equivalent intervention period in children with CP by quasi randomized controlled study design. In addition, the selection and examination of outcome measures were based on the ICF-CY model to provide comprehensively documents.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 13
Healthy Volunteers: f
View:

• aged between 5 and 13 years

• diagnosed with congenital hemiplegic or children with CP with one more affected side

• apparently disuse phenomenon of the more affected hand at spontaneous contexts

⁃ Participants will be exclude for:

• excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment

• severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation

• injections of botulinum toxin type A or operations on the UE within 6 months

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Tien-Ni Wang
tnwang@ntu.edu.tw
3366-8163
Time Frame
Start Date: 2017-06-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 60
Treatments
Experimental: Intensive CIT Model Program
In day camp model, the therapist will monitor and modify the activities to fit each child's ability and need (e.g. implementing task analysis, grading the challenge for each individual with varying capabilities) to make sure the intervention quality is equivalence to the individualized treatment.The day camp model will be arranged as Adventure Camp that decorating the treatment place as the adventure world and the participants take role as a warrior. This novel design is mean to enhance and motivate the engagement of participation.
Experimental: Distributed CIT Model Program
All treatment activities will be focused on the training of the more affected upper limbs with contextual restraint. Investigators choose this child-friendly way to restraint children's non or less impaired hand without any devices. Investigators will provide a unilateral activities and verbal cues to restraint participants' non or less affected side. All tailored activities will be designed as fun and age-appropriated based on the child's preference and parents' concerns. In order to help children to generalize the therapeutic gains to the real world environment, the intervention will take place in the natural environment such as home or school where it may be easier to identify real practical problems and makes the family or caregivers involved more closely and directly.
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov