Dynamic Splinting for Plantarflexion in Spastic Hemiplegia

Not Applicable

Withdrawn

• Conditions: Spastic Hemiplegia
• Interventions: Other: Standard of care; Device: Ankle Dorsiflexion Dynasplint

• Registration Number: NCT01329705
• Lead Sponsor: Dynasplint Systems, Inc.

Brief Summary

The purpose of this study is to examine the effectiveness of onabotulinum toxin A (BTX) injections (tone management) and dynamic splinting (contracture reduction) for improving gait patterns in patients with spastic hypertnoia due to stroke or traumatic brain injury and resultant excessive plantarflexion.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Study Start: 2011-05
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-08
• Last Update Posted: 2013-08-12
• Primary Completion: 2015-05
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients enrolled will be male or female, be at least 18 years of age, and have been diagnosed with spastic hemiplegia and excessive plantarflexion, which includes the following:

  1. Diagnosis of a stroke or traumatic brain injury more than 6 months prior to enrollment in this study
  2. Reduced AROM and PROM in ankle dorsiflexion
  3. Ability to ambulate safely 20 feet without an ankle-foot orthosis (AFO)
  4. Inability to ambulate with initial heel-contact
  5. No prior BTX treatment within 6 months
  6. R1 of -10° or greater (using the Tardeiu method of assessment)
  7. Mean Ashworth Scale Test ≥3 for plantarflexors

Exclusion Criteria

1. Bell's Palsy
2. Viral Encephalitis
3. Muscular Dystrophy
4. Multiple Sclerosis
5. Prior heel-cord lengthening or tendon-transfer procedure in the foot/ankle
6. Subjects with a fixed contracture of the ankle
7. Female subjects who are pregnant (positive urine pregnancy test), who have an infant they are breastfeeding, or are of childbearing potential and do not practice a reliable method of birth control
8. Bleeding disorders
9. Diagnosis of a disease that may interfere with neuromuscular function (ie. Myasthenia Gravis, Lambert-Eaton Myasthenic Syndrome, amyotrophic lateral sclerosis)
10. Subjects currently using aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function
11. Subjects with profound weakness or atrophy of the muscles in the target areas of injection
12. Active systemic infection or infection at the injection site
13. Allergy or sensitivity to botulinum toxin A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard of care	All patients will be treated with the current standard of care including onabotulinum toxin
Dynasplint	Ankle Dorsiflexion Dynasplint	Patients in the experimental Dynasplint group will be treated with the current standard of care, including onabotulinum toxin, and use the Ankle Dorsiflexion Dynasplint

Primary Outcome Measures

Name	Time	Method
Change in gait pattern	12 weeks

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States