Status:
RECRUITING
Effect of Task-Specific Training in an Augmented Reality Context on Upper Limb Function and Activities in Children With Spastic Cerebral Palsy
Lead Sponsor:
Universidade Federal de Sao Carlos
Conditions:
Cerebral Palsy, Spastic
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
Children with Cerebral Palsy (CP), a condition that affects movement and coordination, face difficulties in daily activities such as dressing, reaching for objects in high places, and getting up from ...
Detailed Description
Cerebral Palsy (CP) is defined as a group of permanent disorders of movement and posture development, caused by non-progressive brain injuries to the fetal or developing brain. The prevalence is 2.3 t...
Eligibility Criteria
Inclusion
- In the experimental and control groups, children who have been medically diagnosed with cerebral palsy, either unilateral or bilateral, with spasticity classification, will be included.
- Participants must be classified at GMFCS levels I and II, meaning they are capable of walking independently.
- The MACS (Manual Ability Classification System) should be between levels I (manipulates objects easily), II (manipulates most objects with reduced quality and speed), and III (manipulates objects with difficulty).
- The modified Ashworth score should be between 0 and 2.
- Ability to understand verbal commands and good comprehension of the proposed games.
Exclusion
- Children with dystonic tone classification (identified by the Hypertonia Assessment Tool (HAT)), athetoid, or ataxic.
- GMFCS levels III, IV, and V.
- MACS levels IV and V.
- Modified Ashworth score of 3 to 4.
- Undergoing orthopedic surgical procedures within the past year.
- Receiving chemical blocks within the last 6 months.
- Deformities (muscle shortening and/or loss of joint mobility in the upper limbs) that prevent or compromise the ability to reach the midline.
- Presence of visual and/or auditory sensory deficits not corrected with devices.
- Use of medications that may alter muscle strength or tone.
- Cardiovascular limitations of any intensity, such as excessive fatigue, low exercise tolerance.
- Children who have undergone other intensive therapies within the past 6 months.
- Children with cognitive impairment indicated by caregivers or perceived by researchers due to difficulties in understanding verbal commands and virtual reality games.
- Children who do not accept playing augmented reality games.
Key Trial Info
Start Date :
May 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06571929
Start Date
May 21 2024
End Date
November 1 2026
Last Update
August 26 2024
Active Locations (1)
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1
Federal University of São Carlos (UFSCar)
São Carlos, São Paulo, Brazil, 13565-905