Efficacy of Intermittent Serial Casting on Spastic Wrist Flexion Deformity
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Botulinum toxin A
Occupational Therapy
Intermittent serial casting
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, casting, Botulinum toxin A
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.
Sites / Locations
- Kocaeli University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Casting Group
Control Group
Arm Description
Patients treated by botulinum toxin A and occupational therapy and intermittent serial casting
Patients treated by botulinum toxin A and occupational therapy
Outcomes
Primary Outcome Measures
Mean change from baseline Passive ROM
Range of motion measurement
Mean change from baseline MAS score
Tone measurement
Secondary Outcome Measures
Mean change from XV3 angle of Tardieu scale
Spasticity measurement
Full Information
NCT ID
NCT03306212
First Posted
October 5, 2017
Last Updated
March 26, 2018
Sponsor
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT03306212
Brief Title
Efficacy of Intermittent Serial Casting on Spastic Wrist Flexion Deformity
Official Title
Effectiveness of Intermittent Serial Casting on Spastic Wrist Flexion Deformity in Children With Cerebral Palsy Treated By Botulinum Toxin A
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, casting, Botulinum toxin A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Casting Group
Arm Type
Experimental
Arm Description
Patients treated by botulinum toxin A and occupational therapy and intermittent serial casting
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients treated by botulinum toxin A and occupational therapy
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin A
Other Intervention Name(s)
Dysport
Intervention Type
Other
Intervention Name(s)
Occupational Therapy
Intervention Type
Other
Intervention Name(s)
Intermittent serial casting
Primary Outcome Measure Information:
Title
Mean change from baseline Passive ROM
Description
Range of motion measurement
Time Frame
12 weeks
Title
Mean change from baseline MAS score
Description
Tone measurement
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Mean change from XV3 angle of Tardieu scale
Description
Spasticity measurement
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Kocaeli University
City
Kocaeli
ZIP/Postal Code
41050
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of Intermittent Serial Casting on Spastic Wrist Flexion Deformity
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