Skip to content

Soft Robotics for Infants With Cerebral Palsy

Soft Robotics for Improved Standing and Walking in Infants With Cerebral Palsy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05580497
Enrollment
40
Registered
2022-10-14
Start date
2021-07-08
Completion date
2024-08-31
Last updated
2022-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Brief summary

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.

Interventions

DEVICESoft Wearable Robotic Knee System

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

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Gross Motor Function Classification SystemWithin one month after the last training sessionIt categorized the gross motor function of children and young people with cerebral palsy into 5 different levels. With level 1: Children walk at home, school, outdoors and in the community, while level 5: Children are transported in a manual wheelchair in all settings.

Secondary

MeasureTime frameDescription
6-Minute-Walk TestWithin one month after the last training sessionIt is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
10-Meter-Walk TestWithin one month after the last training sessionIt is a performance measure used to assess walking speed in meters per second over a short distance.
Timed Up and Go testWithin one month after the last training sessionIt is used to determine fall risk and measure the progress of balance, sit to stand and walking.
Five Times Sit to Stand TestWithin one month after the last training sessionIt is used to assess functional lower extremity strength, transitional movements, balance, and fall risk.
Berg Balance ScaleWithin one month after the last training sessionIt is used to objectively determine a person's ability to safely balance during a series of predetermined tasks. It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.

Countries

Hong Kong

Contacts

Primary ContactRaymond Tong, PhD
kytong@cuhk.edu.hk+852 3943 8454

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026