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New treatment option for Cerebral Palsy, Spastic
Official title Effect of Task-Specific Training in an Augmented Reality Context on Upper Limb Function and Activities in Children With Spastic Cerebral Palsy
ClinicalTrials.gov ID: NCT06571929
What this study is testing
- What it's testing
- 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 seats. These challenges can negatively impact the quality of life for these children.
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 12. Healthy volunteers may be eligible.
You may be able to join if
- In the experimental and control groups, children who have been medically diagnosed with cerebral palsy, either unilateral or bilateral, with...
- 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...
- The modified Ashworth score should be between 0 and 2.
- Ability to understand verbal commands and good comprehension of the proposed games.
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Carlos, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 12 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Carlos, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.