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CMT Gait, Mobility, Balance - AOFAS Grant

ConditionCharcot Marie Tooth Disease (CMT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-55
SponsorBopha Chrea

About this trial

The overall objective of the proposed research is to begin to better understand the potential benefits and limitations of ankle -foot orthosis (AFO) use in the context of mobility and balance during gait for individuals with Charcot-Marie-Tooth disease (CMT). These benefits will be studied in comparison to those offered by surgical correction. We will accomplish by having subjects undergo mobility and balance tests in our gait analysis lab.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Ankle-foot Orthoses

    Device

    Group 1 will consist of individuals who have CMT and have undergone surgical correction (OP) and Group 2 will be AFO users who have CMT but have not undergone major surgical correction (NonOP).

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: OPNo intervention 0 interventions
Group B: NonOPOther 1 intervention

Trial outcomes

Primary outcomes

1

Four-Square Step Test

This test of functional mobility requires rapid stepping and changes in direction, that are often limited by lower limb pathology.

Time frame
Baseline
2

Self-selected Walking Velocity

Participants will be instructed to walk at their "normal comfortable" pace for a 10 m distance. The time traveled between the 2 m mark and 8 m mark is recorded in seconds. Two trials will be completed with 15 seconds rest between trials.

Time frame
Baseline
3

Activity Specific Balance Confidence Scale

The ABC is a well-established survey instrument to assess an individual participant's level of balance confidence during functional activities and takes approximately 3 minutes to complete.

Time frame
Baseline
4

Falls Frequency Questionnaire

Survey asking participants the number of times they fell in the previous 24 hours and the previous week. Participants will also be asked to report the most circumstances most commonly associated with fall events.

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bopha Chrea

Lead sponsor

University of Iowa

Sponsor institution

Source ClinicalTrials.gov
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