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Neuromuscular Mechanisms of Specific Trunk Interventions in Children With CP

Shirley Ryan AbilityLab logo

Shirley Ryan AbilityLab

Status

Enrolling

Conditions

Child Behavior

Treatments

Behavioral: Conventional physical therapy
Behavioral: robotic hippotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05805410
R01NS115487

Details and patient eligibility

About

Determine the effect of repeated pelvis perturbation training on trunk posture and locomotor function in children with CP.

Full description

We will determine whether repeat exposure to pelvis perturbation during sitting astride will induce functional improvements in trunk postural control and locomotion in children with CP.

Enrollment

44 estimated patients

Sex

All

Ages

4 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children with a diagnosis of bilateral spastic CP attributed to complications of prematurity, intracranial hemorrhage and periventricular leukmalacia according to the definition of Bax.
  • Children aged 4 to 12 years old without Botulinum toxin treatment within 6 months, and without surgeries (such as selective dorsal rhizotomy) within 12 months before the onset of the training.
  • Subjects will be able to remain seated without help for ≥10s.
  • GMFCS levels will be I to IV.
  • Children must be able to signal pain, fear or discomfort reliably.
  • Children with mild scoliosis (Cobb angle < 20 °).
  • Children with CP who have no prior hippotherapy experiences within 6 months.

Exclusion criteria

  • severe lower extremity contractures, fractures, osseous instabilities, osteoporosis.
  • severe disproportional bone growth.
  • unhealed skin lesions in the lower extremities.
  • thromboembolic diseases, cardiovascular instability.
  • aggressive or self-harming behaviors.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

Robotic hippotherapy
Experimental group
Description:
For the robotic training group, each subject will be trained for 40 minutes. Specifically, each participant will sit astride on a robotic horse with the force perturbation will be applied in the anterior-posterior direction and up/down direction.
Treatment:
Behavioral: robotic hippotherapy
Conventional physical therapy
Active Comparator group
Description:
For the conventional physical therapy group, each subject will be trained for 40 minutes, which will include 10 minutes of stretching, followed by 10 minutes of sitting and 10 minutes of standing balance training, and 10 minutes of treadmill walking.
Treatment:
Behavioral: Conventional physical therapy

Trial contacts and locations

1

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Central trial contact

Ming Wu

Data sourced from clinicaltrials.gov

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