Impact of Foot Orthoses on Gait in Individuals With Ataxia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Home wearing schedule.
- Who it may be relevant to
- Registry conditions: Ataxia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Evaluation of Functional Performance in Patients With Lower Limb Orthoses
Overview
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.
Detailed description
This study is the first randomized controlled trial to evaluate the impact of orthoses on the gait and balance of individuals with ataxia. Prior studies have suggested that foot orthoses may provide stability to improve lower extremity mechanics2, 3 by potentially reducing degrees of freedom3 or by enhancing proprioceptive feedback12, 13, yet no clinical trials have systematically tested these effects in CA, a population with unique joint kinematics and sensory integration challenges. In general, there is a paucity of literature for individuals with CA.14 However, there are many neurologic diagnoses that find orthoses to be beneficial for balance,5, 15, 16 gait,17, 18 and functional mobility.19
Interventions
- Device Home wearing schedule
Participants will wear the orthoses at home and record the time
Primary outcome measures
- Zeno Walkway [Time frame: Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.]
- Zeno Walkway [Time frame: Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.]
Secondary outcome measures (2)
- 6 MWT [Time frame: Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.]
- Quebec User Evaluation of Satisfaction with Assistive Technology (survey) [Time frame: After 14 days after wearing the orthosis.]
Eligibility criteria
Inclusion criteria
- Cerebellar ataxia diagnosed by a physician
- Ambulatory for 16 feet (Zeno mat) with assistance and without assistive device(s)
- 18 years or older
Exclusion criteria
- Gait velocity >/= 100 cm/sec without an assistive device
- Medically diagnosed orthopedic conditions or injuries that impact ambulation
- Unhealed wounds on the feet
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UT Southwestern Medical Center — Dallas
Identifiers
NCT: NCT07720700 · STU-2020-0059