Efficacy of Intermittent Serial Casting on Spastic Wrist Flexion Deformity

NCT ID: NCT03306212

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-01
• Study Completion Date: 2017-12-01

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.

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.

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Casting Group

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

Group Type: EXPERIMENTAL

Botulinum toxin A

Intervention Type: DRUG

Occupational Therapy

Intervention Type: OTHER

Intermittent serial casting

Intervention Type: OTHER

Control Group

Patients treated by botulinum toxin A and occupational therapy

Group Type: ACTIVE_COMPARATOR

Botulinum toxin A

Intervention Type: DRUG

Occupational Therapy

Intervention Type: OTHER

Interventions

Botulinum toxin A

Intervention Type: DRUG

Occupational Therapy

Intervention Type: OTHER

Intermittent serial casting

Intervention Type: OTHER

Other Intervention Names

Dysport

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Nigar Dursun

Head of PMR Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kocaeli University

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KOU KAEK 2014/269

Identifier Type: -

Identifier Source: org_study_id