Efficacy of Intermittent Serial Casting on Spastic Wrist Flexion Deformity

NCT03306212 | Completed Phase 3 DMC

• 1 other identifier: KOU KAEK 2014/269
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; casting; Botulinum toxin A

Outcome Measures

Primary Outcomes (2)

• Mean change from baseline Passive ROM

  Range of motion measurement

  12 weeks

• Mean change from baseline MAS score

  Tone measurement

  12 weeks

Secondary Outcomes (1)

• Mean change from XV3 angle of Tardieu scale

  12 weeks

Study Arms (2)

Casting Group

EXPERIMENTAL

Patients treated by botulinum toxin A and occupational therapy and intermittent serial casting

Drug: Botulinum toxin A; Other: Occupational Therapy; Other: Intermittent serial casting

Control Group

ACTIVE COMPARATOR

Patients treated by botulinum toxin A and occupational therapy

Drug: Botulinum toxin A; Other: Occupational Therapy

Interventions

Botulinum toxin A DRUG

Also known as: Dysport

Casting Group; Control Group

Occupational Therapy OTHER

Casting Group; Control Group

Intermittent serial casting OTHER

Casting Group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA; Occupational Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of PMR Department

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 10, 2017
• Study Start: November 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 27, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)