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Efficacy of a Hip Brace for Hip Displacement in Children With Cerebral Palsy: A Randomized Clinical Trial
Bo Ryun Kim1, Jin A Yoon2, Hyun Jung Han3
1Department of Physical Medicine and Rehabilitation, Anam Hospital, Korea University College of Medicine, Seoul, South Korea.
Insights
A novel hip brace effectively prevented hip displacement progression in children with cerebral palsy. This intervention also improved their quality of life, potentially delaying the need for surgery.
Area of Science:
- Orthopedics
- Pediatric Rehabilitation
- Biomedical Engineering
Background:
- Hip displacement is a common complication in nonambulatory cerebral palsy, with no established interventions to slow its progression.
- Current management strategies for hip displacement in cerebral palsy lack consensus, highlighting the need for effective treatments.
Purpose of the Study:
- To evaluate the efficacy of a novel hip brace in preventing progressive hip displacement in children with cerebral palsy.
- To assess the impact of the hip brace on the quality of life for these patients.
Main Methods:
- A randomized clinical trial involving 66 children (aged 1-10 years) with nonambulatory cerebral palsy (GMFCS IV-V) across four South Korean hospitals.
- Participants were randomized into an intervention group (hip brace use ≥12 hours/day for 12 months) and a control group, both receiving conventional rehabilitation.
- The primary outcome was the Reimers migration index (MI) assessed radiographically; secondary outcomes included quality of life measured by the Caregiver Priorities & Child Health Index of Life with Disabilities.
Main Results:
- The hip brace group showed a significantly greater reduction in the Reimers migration index at 6 months (-8.7 percentage points) and 12 months (-12.7 percentage points) compared to the control group.
- Patients using the hip brace experienced statistically significant improvements in quality of life at the 6-month follow-up.
- No adverse events related to the brace were reported.
Conclusions:
- The novel hip brace is a safe and effective intervention for preventing the progression of hip displacement in nonambulatory cerebral palsy.
- Hip brace utilization can enhance the quality of life for children with cerebral palsy, potentially postponing the need for surgical intervention.
Importance:
There is no consensus on interventions to slow the progress of hip displacement in patients with cerebral palsy.
Objective:
To investigate the efficacy of a novel hip brace in preventing progressive hip displacement in patients with cerebral palsy.
Design, Setting, And Participants:
This 2-group randomized clinical trial was conducted at 4 tertiary hospitals in South Korea from July 2019 to November 2021. Participants included children aged 1 to 10 years with nonambulatory cerebral palsy (Gross Motor Function Classification System level IV or V). Block randomization was used to assign an equal number of patients to the study and control groups via computerized random allocation sequences. Data were analyzed from November to December 2021.
Interventions:
The intervention group wore the hip brace for at least 12 hours a day for the study duration (ie, 12 months). Follow-up evaluations were performed after 6 and 12 months of wearing the brace. Both groups proceeded with conventional rehabilitation therapy during the trial.
Main Outcomes And Measures:
The primary outcome was the Reimers migration index (MI) on radiography, as assessed by 3 blinded investigators. Primary outcome variables were analyzed using linear mixed models. Secondary outcomes include change in the Caregiver Priorities & Child Health Index of Life with Disabilities, on which lower scores indicate better quality of life.
Results:
A total of 66 patients were included, with 33 patients (mean [SD] age, 68.7 [31.6] months; 25 [75.8%] boys) randomized to the intervention group and 33 patients (mean [SD] age, 60.7 [24.9] months; 20 [60.6%] boys) randomized to the control group. The baseline mean (SD) MI was 37.4% (19.3%) in the intervention group and 30.6% (16.3%) in the control group. The mean difference of the MI between the intervention group and control group was -8.7 (95% CI, -10.2 to -7.1) percentage points at 6 months and -12.7 (95% CI, -14.7 to -10.7) percentage points at 12 months. The changes in the Caregiver Priorities & Child Health Index of Life with Disabilities were favorable in the study group and reached statistical significance at the 6-month follow-up compared with the control group (difference, -14.2; 95% CI, -25.2 to -3.3).
Conclusions And Relevance:
In this randomized clinical trial, the novel hip brace was significantly effective in preventing the progression of hip displacement, compared with the control group. It effectively improved quality of life in patients with nonambulatory cerebral palsy. Therefore, hip brace use could be a promising treatment method to delay hip surgery and improve the quality of life of patients with nonambulatory cerebral palsy.
Trial Registration:
ClinicalTrials.gov Identifier: NCT04033289.
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