Ataxia
Conditions
Keywords
Ataxia, Orthoses, Gait
Brief summary
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
DEVICEHome wearing schedule
Participants will wear the orthoses at home and record the time
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Zeno Walkway | Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis. | This is kinematic gait information including gait velocity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 MWT | Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis. | 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. |
| Quebec User Evaluation of Satisfaction with Assistive Technology (survey) | After 14 days after wearing the orthosis. | 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. |
Countries
United States
Contacts
CONTACTStaci M Shearin, PT, PhD
Outcome results
None listed