Efficacy of Intermittent Serial Casting on Spastic Wrist Flexion Deformity

Sponsor

Kocaeli University (Other)

Overall Status

Completed

CT.gov ID

NCT03306212

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy	Drug: Botulinum toxin A Other: Occupational Therapy Other: Intermittent serial casting	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Casting Group Patients treated by botulinum toxin A and occupational therapy and intermittent serial casting	Drug: Botulinum toxin A Other Names: Dysport Other: Occupational Therapy Other: Intermittent serial casting
Active Comparator: Control Group Patients treated by botulinum toxin A and occupational therapy	Drug: Botulinum toxin A Other Names: Dysport Other: Occupational Therapy

Arm

Intervention/Treatment

Experimental: Casting Group

Patients treated by botulinum toxin A and occupational therapy and intermittent serial casting

Drug: Botulinum toxin A

Other Names:

Dysport

Other: Occupational Therapy

Other: Intermittent serial casting

Active Comparator: Control Group

Patients treated by botulinum toxin A and occupational therapy

Drug: Botulinum toxin A

Other Names:

Dysport

Other: Occupational Therapy

Outcome Measures

Primary Outcome Measures

Mean change from baseline Passive ROM [12 weeks]
Range of motion measurement
Mean change from baseline MAS score [12 weeks]
Tone measurement

Secondary Outcome Measures

Mean change from XV3 angle of Tardieu scale [12 weeks]
Spasticity measurement

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.