Walking Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-88
SponsorBaltimore VA Medical Center
About this trial
The purpose of this research study is to test the utility of an ankle robot, when used during treadmill walking, in people with ankle weakness and foot drop from a peripheral nervous system injury due to neuromuscular or orthopedic injury.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women, aged 18 to 88 years
Chronic foot drop and ankle weakness in one leg from a peripheral nervous system injury due to a neuromuscular or orthopedic injury
Ability to walk 10 meters and arise from a chair with no human assistance (but usage of usual assistive device[s] is permitted)
Disqualifiers
Cardiac history of (a) unstable angina; (b) recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II); and/or (c) hemodynamically significant valvular dysfunction
Hypertension that is a contraindication for a bout of walking training (greater than 160/100 mmHg on two assessments)
Medical history of (a) recent hospitalization (less than 3 months) for severe medical disease; (b) symptomatic peripheral arterial occlusive disease; (c) orthopedic or chronic pain conditions that significantly alter gait function; (d) pulmonary or renal failure; and/or (e) active cancer
Current participation in orthopedic or rehabilitation medical programs
Trial design
Design model
Single group
Treatments tested in this trial
Treadmill Ankle Robot Training
DeviceThis intervention employs the use of an adaptive ankle robot control system, during treadmill walking, over a 6-week intervention period.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Treadmill Ankle Robot TrainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Gait velocity during self-selected overground walking
cm/sec
Time frame
Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training2
Peak dorsiflexion angle during swing phase of gait
degrees; extent of ankle dorsiflexion to enable foot clearance
Time frame
Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training3
Ankle dorsiflexion-plantarflexion range of motion
degrees
Time frame
Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training4
Postural sway areas during quiet standing
cm\^2; extent of postural deviations to assess static postural control
Time frame
Change from baseline to: post-6 weeks of training, and 6 weeks after completion of trainingLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: