Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-29 @ 3:26 AM
Study NCT ID:
NCT01796860
Status:
TERMINATED
Last Update Posted:
2015-08-21
First Post:
2013-02-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Ankle Foot Orthoses on Gait in Multiple Sclerosis
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
The Impact of Ankle Foot Orthosis (AFO) on Gait Recovery in Select Individuals With Multiple Sclerosis (MS)
Status:
TERMINATED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Modifications were made to protocol, new IRB pending
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. This orthotic is fabricated to allow ankle range of motion required for normal gait kinematics. Additionally, it controls forward progression of the tibia during the stance phase of gait. This study has three hypotheses 1. Individuals who are fit with the AFO will demonstrate improvements in spatial and temporal gait parameters 2. Individuals who are fit with the AFO will demonstrate improvements in walking endurance, and 3. Individuals who are fit with the AFO will demonstrate improvements in muscle firing profiles/EMG measures.
Detailed Description:
This is a non-randomized, single group (N=15), repeated measures study. The study will take place at the David M. Crowley Research and Rehabilitation Lab in the School of Health Professions at University of Texas Southwestern Medical Center. The outcome measures for the study include: 1. GAITRite System for temporal and spatial parameters, 2. EMG of the anterior tibialis, gastrocnemius, and vastus lateralis muscles, 3. 6 Minute Walk Test (gait endurance) 4. Lower extremity strength, 5. MS Fatigue scale, 6. Observational Gait Analysis - Video tape of over ground walking. This study will be 13 weeks long. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10. They will be 60 minutes in duration. Outcome measures will be assessed at the following times: initial (T1), week 5 (T2), and week 13 (T3). Subjects will be closely monitored throughout the 13 week study and will be un-enrolled by self-request or the following medical reasons: 1. Acute exacerbation of MS symptoms, 2. New diagnosis with direct consequences affecting gait training, 3. Inability to tolerate the study AFO.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: