Impact of Foot Orthoses on Gait in Individuals With Ataxia
ConditionAtaxia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
This study is the first to assess the impact of lower extremity orthoses on gait and balance in individuals with CA. By investigating how orthoses influence mobility and stability, this research will provide critical data to inform clinical guidelines, improve patient care, and support evidence-based orthotic prescriptions for individuals with CA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cerebellar ataxia diagnosed by a physician
Ambulatory for 16 feet (Zeno mat) with assistance and without assistive device(s)
18 years or older
Disqualifiers
Gait velocity >/= 100 cm/sec without an assistive device
Medically diagnosed orthopedic conditions or injuries that impact ambulation
Unhealed wounds on the feet
Trial design
Design model
Parallel
Treatments tested in this trial
Home wearing schedule
DeviceParticipants will wear the orthoses at home and record the time
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Custom orthosesExperimental treatment 1 intervention
Group B: Off the shelfExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Zeno Walkway
This is kinematic gait information including gait velocity.
Time frame
Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.2
Zeno Walkway
This measures kinematic data such as step length.
Time frame
Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.Secondary outcomes
1
6 MWT
This test measures submaximal aerobic functional walking capacity. Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes.
Time frame
Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.2
Quebec User Evaluation of Satisfaction with Assistive Technology (survey)
This is a self-reported outcome measure that will be done at the last testing time point to assess participant considerations (ease of use for device, participant observations, perceived improvements in QOL). A higher score indicates higher levels of satisfaction.
Time frame
After 14 days after wearing the orthosis.Sponsors and contacts
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Source ClinicalTrials.gov