Soft Robotics for Infants With Cerebral Palsy

NCT ID: NCT05580497

Last Updated: 2022-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-08

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Soft Wearable Robotic Knee System

30 minutes gait training wearing the Soft Wearable Robotic Knee System

Group Type EXPERIMENTAL

Soft Wearable Robotic Knee System

Intervention Type DEVICE

Power assistance will be provided from the motor to the knee joint

Interventions

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Soft Wearable Robotic Knee System

Power assistance will be provided from the motor to the knee joint

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Raymond KY Tong

Professor and Chairman

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raymond Tong, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Biomedical Engineering, The Chinese University of Hong Kong

Locations

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Department of Biomedical Engineering, The Chinese University of Hong Kong

Shatin, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Raymond Tong, PhD

Role: CONTACT

+852 3943 8454

Facility Contacts

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Raymond Tong, PhD

Role: primary

+852 3943 8454

Other Identifiers

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2021.171

Identifier Type: -

Identifier Source: org_study_id

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