Efficacy of Intermittent Serial Casting on Spastic Wrist Flexion Deformity

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306212
• Other study ID #: KOU KAEK 2014/269
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2017
• Last updated: March 26, 2018
• Start date: November 1, 2014
• Est. completion date: December 1, 2017

Study information

• Verified date: March 2018
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Drug:
• Botulinum toxin A

Other:
• Occupational Therapy

• Intermittent serial casting

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline Passive ROM	Range of motion measurement	12 weeks
Primary	Mean change from baseline MAS score	Tone measurement	12 weeks
Secondary	Mean change from XV3 angle of Tardieu scale	Spasticity measurement	12 weeks