Efficacy of Intermittent Serial Casting on Spastic Wrist Flexion Deformity

Study Overview
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Brief Summary
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Spastic wrist flexion deformity is a very common problem in children with CP. Although serial casting (SC) is one of the commonly used interventions in addition to botulinum toxin A (BoNT-A) injections and physical therapy for spastic deformities of lower extremity of children with CP, there is limited data on SC in the upper extremity. In this prospective, randomized, controlled clinical trial in order to overcome the issues with patient compliance, side effects and combined treatment options an intermittent SC model was developed. The objective of this study was to show the effects of intermittent SC when combined with occupational therapy (OT) and BoNT-A injections on spasticity, and passive range of motion (pROM) of children with CP having spastic wrist flexion deformity.

Detailed Description
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Spasticity is not only the most common motor disorder but also the main cause of slowly developing secondary problems like contractures in children with cerebral palsy (CP). Spastic wrist flexion deformity is a very common problem in children with CP and can be primarily due to spasticity of the palmar muscle complex, can be exacerbated by the weakness of the antagonist dorsiflexor muscles and can involve soft tissue and joint contractures. Although serial casting (SC) is one of the commonly used interventions in addition to botulinum toxin A (BoNT-A) injections and physical therapy for spastic deformities of lower extremity of children with CP, there is limited data on SC in the upper extremity. Skin irritation or breakdown, painful epizodes, oedema, tendonitis, weakness, stiffness are some of the side effects reported after SC. Moreover casting especially when prolonged might complicate activities of daily living for instance by increasing the risk of falls or causing problems in bathing. Recent evidence from literature favors early, goal oriented, activity based, intensive, repetitive motor trainings in enriched environments to optimize neuroplasticity in children with CP. Prolonged serial casting might also interfere with these activity based, intensive rehabilitation options for upper extremity. In this prospective, randomized, controlled clinical trial in order to overcome the issues with patient compliance, side effects and combined treatment options an intermittent SC model was developed. The objective of this study was to show the effects of intermittent SC when combined with occupational therapy (OT) and BoNT-A injections on spasticity, and passive range of motion (pROM) of children with CP having spastic wrist flexion deformity.

Official Title
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Effectiveness of Intermittent Serial Casting on Spastic Wrist Flexion Deformity in Children With Cerebral Palsy Treated By Botulinum Toxin A

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Drug: Botulinum toxin A
* Other: Occupational Therapy
* Other: Intermittent serial casting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: having a diagnosis of CP according to Rosenbaum criteria, having a unilateral spastic palmar flexion deformity of wrist joint, having a Modified Ashworth Scale (MAS) score of 3 in the palmar flexor muscle complex, being scheduled for BoNT-A treatment to upper extremity including palmar flexor muscle group. Exclusion Criteria: having cognitive dysfunction, having a history of orthopedic surgery to upper extremity, having significant dystonia, having infection skin breakdown, having vascular disease, having fracture or dislocation.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Casting Group<br>Patients treated by botulinum toxin A and occupational therapy and intermittent serial casting | Drug: Botulinum toxin A<br> <br> * Other names: Dysport;Other: Occupational Therapy<br> <br> Other: Intermittent serial casting<br> <br> |
| Active Comparator: Control Group<br>Patients treated by botulinum toxin A and occupational therapy | Drug: Botulinum toxin A<br> <br> * Other names: Dysport;Other: Occupational Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline Passive ROM | Range of motion measurement | 12 weeks | 
| Mean change from baseline MAS score | Tone measurement | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from XV3 angle of Tardieu scale | Spasticity measurement | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy, casting, Botulinum toxin A