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Trial Outcomes & Findings for The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS) (NCT NCT01947582)

NCT ID: NCT01947582

Last Updated: 2016-03-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

Assessed at visit 2 (week 1) and week 24

Results posted on

2016-03-07

Participant Flow

Participant milestones

Participant milestones
Measure
Application of Ankle Foot Orthosis
persons in this group were fitted with bilateral ankle foot orthoses
Overall Study
STARTED
2
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Application of Ankle Foot Orthosis
persons in this group were fitted with bilateral ankle foot orthoses
Overall Study
Withdrawal by Subject
1

Baseline Characteristics

The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Application of Ankle Foot Orthosis
n=1 Participants
persons in this group were fitted with bilateral ankle foot orthoses
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
48 years
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
1 participants
n=5 Participants

PRIMARY outcome

Timeframe: Assessed at visit 2 (week 1) and week 24

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.

Outcome measures

Outcome measures
Measure
Application of Ankle Foot Orthosis
n=1 Participants
persons in this group were fitted with bilateral ankle foot orthoses
Change in Walking Distance During 6-Minute Walk Test
222 feet

SECONDARY outcome

Timeframe: Assessed at visit 2 (week 1) and week 24

The 12-Item Walk Scale is a paper and pencil test that asks persons with MS to rate their level of fatigue when doing functional tasks. The maximum possible score is 60 points and the lowest possible score is 12. Higher scores indicate a greater impact on walking than lower scores.

Outcome measures

Outcome measures
Measure
Application of Ankle Foot Orthosis
n=1 Participants
persons in this group were fitted with bilateral ankle foot orthoses
Change in Impact of MS on Fatigue Using the 12-Item Walk Scale
1 difference of sum of score

SECONDARY outcome

Timeframe: Assessed at visit 2 (week 1) and week 24

Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor.

Outcome measures

Outcome measures
Measure
Application of Ankle Foot Orthosis
n=1 Participants
persons in this group were fitted with bilateral ankle foot orthoses
Change in Step Length Using the GAITRite Computerized Gait Analysis System
3.3 cm

SECONDARY outcome

Timeframe: Assessed at visit 2 (week 1) and week 24

Surface EMG is done on key muscles in the lower extremity (quadriceps, anterior tibialis, gastrocnemius, soleus) during computerized gait assessment. Changes in amplitude of muscle activity or timing of muscle activity would indicate, for example, increases in strength or changes in timing of muscles which might indicate motor learning as a result of wearing the ankle foot orthosis.

Outcome measures

Outcome measures
Measure
Application of Ankle Foot Orthosis
n=1 Participants
persons in this group were fitted with bilateral ankle foot orthoses
Number of Persons With Change in Muscle Activity Using Surface Electromyography (EMG)
1 persons

Adverse Events

Application of Ankle Foot Orthosis

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen McCain, PT, DPT, NCS, Principal Investigator

University of Texas Southwestern Medical Center

Phone: 214-648-1559

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place