Effectiveness of Ankle Foot Orthoses on Gait in Multiple Sclerosis

NCT01796860 | Terminated Results DMC

• 1 other identifier: MS AFO
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Gait; AFO; MS

Outcome Measures

Primary Outcomes (1)

• Change in Step Length From Initial Testing to End of Study

  Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.

  Computerized gait analysis will be done at the time of enrollment and week 13.

Secondary Outcomes (1)

• Number of Participants With Change in Muscle Activity With Surface Electromyography (EMG) of Key Lower Extremity Muscles From Baseline to Final Testing

  Surface EMG will be done at the time of enrollment and week 13.

Other Outcomes (1)

• Change in Walking Endurance Using a 6-Minute Walk Test (6MWT) From Initial Testing to Final Testing

  6MWT will be done at the time of enrollment and week 13.

Study Arms (1)

AFO

OTHER

All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).

Other: AFO

Interventions

AFO OTHER

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. 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.

AFO

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals with a primary diagnosis of multiple sclerosis
• Individuals \>21 and \<60 years old
• Individuals who are able to maintain a walking velocity of 60 cm/sec for at least 2 minutes independently or with the use of a single tip assistive device.
• Current or past history of single or bilateral AFO use, including neuroprostheses
• Evidence of weakness in plantarflexors

You may not qualify if:

• The presence of co-morbidities (neuromuscular or musculoskeletal) that would negatively impact gait training
• Individuals with BMI with \>/= 35kg/m2
• Individuals with range of motion deficit in the ankle limiting passive range of motion to neutral dorsiflexion
• Individuals that will begin the use of Ampyra during the course of the study
• Individuals for whom the cost of an orthosis would represent a financial burden
• Individuals who are receiving concurrent physical therapy services elsewhere,
• Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) of \>22
• Individuals for whom bilateral AFOs are indicated, but have different design

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center, School of Health Professions

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Karen J McCain, PT, DPT, NCS, Principal Investigator
• Organization: University of Texas Southwestern Medical Center

karen.mccain@utsouthwestern.edu

214-648-1559

Study Officials

• Karen McCain, DPT

  UTSW

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Health Professions

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 22, 2013
• Study Start: September 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 21, 2015
• Results First Posted: August 3, 2015

Record last verified: 2015-08

Locations

US (1)