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Completed

NCT Number: NCT03306212

Efficacy of Intermittent Serial Casting on Spastic Wrist Flexion Deformity

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.

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Key information

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kocaeli University

Kocaeli, 41050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum toxin A

Drug

Other names: Dysport

Occupational Therapy

Other

Intermittent serial casting

Other

Primary outcomes

  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 outcomes

  1. Mean change from XV3 angle of Tardieu scale

    Time frame: 12 weeks

    Spasticity measurement

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 10, 2017
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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