search
Back to results

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
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, casting, Botulinum toxin A

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 5, 2017
Last Updated
March 26, 2018
Sponsor
Kirsehir Ahi Evran University
search

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

Learn more about this trial

Efficacy of Intermittent Serial Casting on Spastic Wrist Flexion Deformity

We'll reach out to this number within 24 hrs