Soft Robotics for Infants With Cerebral Palsy

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Cerebral Palsy

Treatments: Device: Soft Wearable Robotic Knee System

Study type: Interventional

Funder types: Other

Identifiers

NCT05580497

2021.171

Details and patient eligibility

About

Children with spastic cerebral palsy suffer from significant weakness that contributes to abnormal posture and movement. It is thought that this arises due lack of frequency sufficient tension to encourage normal muscular growth underlying the need for early intervention to encourage walking. The failure of muscle growth to keep pace with bone growth is most evident in the bi-articular muscles and contributes to joint contractures and gait abnormalities such as toe-walking and flexed-knee gait.

Recently, our research team has developed a novel, lightweight (0.2kg at knee joint) and portable (energetically autonomous) Soft Wearable Robotic Knee System that can provide active powered knee assistance and synchronized proprioceptive feedback for the gait training of stroke patients' standing and walking.

Enrollment: 40 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• capable of understanding the proposed exercises;
• aged 2 to 15 years;
• maximum weight 75 kg;
• children with no deformations that could prevent the use of the exoskeleton;
• Gross Motor Function Classification System (GMFCS) levels I to III;
• able to signal pain or discomfort.

Exclusion criteria

• unhealed skin lesions in the lower limbs;
• aggressive or self-harming behaviors;
• severe cognitive impairment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Soft Wearable Robotic Knee System

Experimental group

Description:

30 minutes gait training wearing the Soft Wearable Robotic Knee System

Treatment:

Device: Soft Wearable Robotic Knee System