NCT01947582

Brief Summary

The purpose of this study is to investigate the impact of ankle foot orthoses (AFOs) on the spatial and temporal gait parameters, electromyography (EMG), walking endurance, and quality of life in select individuals living with MS. The hypotheses of the study are: 1. Individuals who are fit with an AFO will demonstrate improvements in spatial and temporal gait parameters 2. Individuals who are fit with an AFO will demonstrate improvements in walking endurance. 3. Individuals who are fit with an AFO will demonstrate improvements in muscle firing profiles/EMG measures. 4. Individuals who are fit with an AFO will demonstrate improvements in quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
6 months until next milestone

Results Posted

Study results publicly available

June 1, 2015

Completed
Last Updated

March 7, 2016

Status Verified

February 1, 2016

Enrollment Period

1.2 years

First QC Date

September 17, 2013

Results QC Date

May 13, 2015

Last Update Submit

February 4, 2016

Conditions

Multiple Sclerosis

Keywords

multiple sclerosisgaitankle foot orthosis (AFO)

Outcome Measures

Primary Outcomes (1)

  • Change in Walking Distance During 6-Minute Walk Test

    Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary. They will be asked to rate their level of exertion upon completion of walking on the rate of perceived exertion scale.

    Assessed at visit 2 (week 1) and week 24

Secondary Outcomes (3)

  • Change in Impact of MS on Fatigue Using the 12-Item Walk Scale

    Assessed at visit 2 (week 1) and week 24

  • Change in Step Length Using the GAITRite Computerized Gait Analysis System

    Assessed at visit 2 (week 1) and week 24

  • Number of Persons With Change in Muscle Activity Using Surface Electromyography (EMG)

    Assessed at visit 2 (week 1) and week 24

Study Arms (1)

Application of ankle foot orthosis

OTHER

All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.

Device: Ankle foot orthosis

Interventions

Ankle foot orthosisDEVICE

The ankle foot orthoses (AFOs) that will be used are designed to provide assistance with anterior tibial advancement during stance and dorsi flexion assistance during swing. The device(s) are polypropylene and are custom-fabricated.

Application of ankle foot orthosis

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals with a primary diagnosis of multiple sclerosis
  • Individuals who are able to maintain a walking velocity of 30 cm/sec for at least 2 minutes independently or with the use of a single tip assistive device.
  • Could have 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 \>/= 40kg/m2
  • Individuals with range of motion deficit in the ankle limiting passive range of motion to neutral dorsiflexion
  • Individuals that plan to 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
  • MSNQ of \>22

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center School of Health Professions

Dallas, Texas, 75223, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Karen McCain, PT, DPT, NCS, Principal Investigator
Organization
University of Texas Southwestern Medical Center
karen.mccain@utsouthwestern.edu
214-648-1559

Study Officials

  • Karen J McCain, PT, DPT, NCS

    University of Texas Southwestern Medical Center

    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
Associate Professor, School of Health Professions

Study Record Dates

First Submitted

September 17, 2013

First Posted

September 20, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 7, 2016

Results First Posted

June 1, 2015

Record last verified: 2016-02

Locations

US(1)