Neuromuscular Mechanisms of Specific Trunk Interventions in Children With CP

Sponsor
Shirley Ryan AbilityLab (Other)
Overall Status
Recruiting
CT.gov ID
NCT05805410
Collaborator
(none)
44
1
2
49
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: robotic hippotherapy
  • Behavioral: Conventional physical therapy
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to two groupsParticipants will be randomly assigned to two groups
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Neuromuscular Mechanisms of Specific Trunk Interventions in Children With Cerebral Palsy
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Robotic hippotherapy

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.

Behavioral: robotic hippotherapy
A custom designed cable-driven robotic system that mimics horseback movement during walking was used in this study.

Active Comparator: Conventional physical therapy

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.

Behavioral: Conventional physical therapy
Stretching of trunk and leg muscles, followed by sitting and standing balance training, and conventional treadmill walking.

Outcome Measures

Primary Outcome Measures

  1. Change in Trunk Control Measurement Scale (TCMS) score from baseline. [baseline, post 6 weeks of training and 8 weeks after the end of training.]

    The maximum value for the total TCMS is 58 points (no unit). Specifically, there is 20 points for the category 'static sitting balance', 28 points for 'selective movement control', and 10 points for 'dynamic reaching'). A higher TCMS scores indicates a better motor performance in trunk control.

Secondary Outcome Measures

  1. Change in Walking speed from baseline [baseline, post 6 weeks of training and 8 weeks after the end of training.]

    Overground walking speed

  2. Chang in 6-minute walking distance from baseline [baseline, post 6 weeks of training and 8 weeks after the end of training.]

    Walking distance within 6 minutes

  3. Change in GMFM-66 [baseline, post 6 weeks of training and 8 weeks after the end of training.]

    Gross Motor Function Measure

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shirley Ryan AbilityLab Chicago Illinois United States 60611

Sponsors and Collaborators

  • Shirley Ryan AbilityLab

Investigators

  • Principal Investigator: Ming Wu, Shirley Ryan AbilityLab

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ming Wu, Research Scientist, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier:
NCT05805410
Other Study ID Numbers:
  • R01NS115487
First Posted:
Apr 10, 2023
Last Update Posted:
Apr 10, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 10, 2023