Back to resultsDynamic Splinting for Plantarflexion in Spastic Hemiplegia
Primary Purpose
Spastic Hemiplegia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ankle Dorsiflexion Dynasplint
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Spastic Hemiplegia
Eligibility Criteria
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:
- Diagnosis of a stroke or traumatic brain injury more than 6 months prior to enrollment in this study
- Reduced AROM and PROM in ankle dorsiflexion
- Ability to ambulate safely 20 feet without an ankle-foot orthosis (AFO)
- Inability to ambulate with initial heel-contact
- No prior BTX treatment within 6 months
- R1 of -10° or greater (using the Tardeiu method of assessment)
- Mean Ashworth Scale Test ≥3 for plantarflexors
Exclusion Criteria:
- Bell's Palsy
- Viral Encephalitis
- Muscular Dystrophy
- Multiple Sclerosis
- Prior heel-cord lengthening or tendon-transfer procedure in the foot/ankle
- Subjects with a fixed contracture of the ankle
- 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
- Bleeding disorders
- Diagnosis of a disease that may interfere with neuromuscular function (ie. Myasthenia Gravis, Lambert-Eaton Myasthenic Syndrome, amyotrophic lateral sclerosis)
- Subjects currently using aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function
- Subjects with profound weakness or atrophy of the muscles in the target areas of injection
- Active systemic infection or infection at the injection site
- Allergy or sensitivity to botulinum toxin A
Sites / Locations
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Dynasplint
Arm Description
All patients will be treated with the current standard of care including onabotulinum toxin
Patients in the experimental Dynasplint group will be treated with the current standard of care, including onabotulinum toxin, and use the Ankle Dorsiflexion Dynasplint
Outcomes
Primary Outcome Measures
Change in gait pattern
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01329705
Brief Title
Dynamic Splinting for Plantarflexion in Spastic Hemiplegia
Official Title
Dynamic Splinting for Excessive Plantarflexion in Patients With Spastic Hemiplegia: A Randomized, Controlled Study of Gait Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Withdrawn
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynasplint Systems, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Hemiplegia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
All patients will be treated with the current standard of care including onabotulinum toxin
Arm Title
Dynasplint
Arm Type
Experimental
Arm Description
Patients in the experimental Dynasplint group will be treated with the current standard of care, including onabotulinum toxin, and use the Ankle Dorsiflexion Dynasplint
Intervention Type
Device
Intervention Name(s)
Ankle Dorsiflexion Dynasplint
Other Intervention Name(s)
ADFD, AFD
Intervention Description
Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or "Experimental" group will add this therapy to their standard of care regimen
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Patients will begin a 12 week course of physical therapy with once-weekly therapy appointment, focusing on:
range of motion stretching of the Achilles tendon, hamstrings, hip flexors and any other tight musculature
strengthening of tibialis anterior to allow dorsiflexion in swing phase of gait as well as strengthening of other weak musculature
gait training to improve heel strike and toe off, stride length, and gait progression
sensory, proprioceptive training in foot position and degree of plantarflexion or dorsiflexion
no electric stimulation (e-stim) will be utilized
Primary Outcome Measure Information:
Title
Change in gait pattern
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Diagnosis of a stroke or traumatic brain injury more than 6 months prior to enrollment in this study
Reduced AROM and PROM in ankle dorsiflexion
Ability to ambulate safely 20 feet without an ankle-foot orthosis (AFO)
Inability to ambulate with initial heel-contact
No prior BTX treatment within 6 months
R1 of -10° or greater (using the Tardeiu method of assessment)
Mean Ashworth Scale Test ≥3 for plantarflexors
Exclusion Criteria:
Bell's Palsy
Viral Encephalitis
Muscular Dystrophy
Multiple Sclerosis
Prior heel-cord lengthening or tendon-transfer procedure in the foot/ankle
Subjects with a fixed contracture of the ankle
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
Bleeding disorders
Diagnosis of a disease that may interfere with neuromuscular function (ie. Myasthenia Gravis, Lambert-Eaton Myasthenic Syndrome, amyotrophic lateral sclerosis)
Subjects currently using aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function
Subjects with profound weakness or atrophy of the muscles in the target areas of injection
Active systemic infection or infection at the injection site
Allergy or sensitivity to botulinum toxin A
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
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Dynamic Splinting for Plantarflexion in Spastic Hemiplegia
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