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Efficacy of Intermittent Serial Casting on Spastic Wrist Flexion Deformity

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ClinicalTrials.gov Identifier: NCT03306212
Recruitment Status : Completed
First Posted : October 10, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Nigar Dursun, Kocaeli University

Study Description
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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.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : November 1, 2014
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Casting Group
Patients treated by botulinum toxin A and occupational therapy and intermittent serial casting
 Drug: Botulinum toxin A
Other Name: 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 Name: Dysport

Other: Occupational Therapy


Outcome Measures
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Primary Outcome Measures :
  1. Mean change from baseline Passive ROM [ Time Frame: 12 weeks ]
    Range of motion measurement

  2. Mean change from baseline MAS score [ Time Frame: 12 weeks ]
    Tone measurement


Secondary Outcome Measures :
  1. Mean change from XV3 angle of Tardieu scale [ Time Frame: 12 weeks ]
    Spasticity measurement


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306212


Locations
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Turkey
Kocaeli University
Kocaeli, Turkey, 41050
Sponsors and Collaborators
Kocaeli University
More Information
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Responsible Party: Nigar Dursun, Head of PMR Department, Kocaeli University
ClinicalTrials.gov Identifier: NCT03306212    
Other Study ID Numbers: KOU KAEK 2014/269
First Posted: October 10, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nigar Dursun, Kocaeli University:
cerebral palsy
casting
Botulinum toxin A
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
 Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents