Leg Stretching Using an Exoskeleton on Demand for People With Spasticity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
The purpose of this research study is to develop a protocol using a fully wearable, portable lower-limb exoskeleton for improving leg and walking function in people with movement disorders. The study investigates the effects of wearing the device during a set of experiments including leg stretching, treadmill walking and overground walking in muscle activity, joint motion, and gait performance. The goal is to develop an effective lower-limb strategy to restore lost leg function (e.g., range of motion) and gait ability, and improve quality of life in people with movement deficits following a neurological disorder.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Veteran individuals with spasticity due to spinal cord injury (SCI) at least 6 months post SCI
Capable of providing informed consent and reporting age, gender, and neurological condition
Neurologically stable (>6 months post-SCI) and can wear the device and the sensors, provide written informed consent, and follow instruction
Disqualifiers
Participants should not experience another neurological disorder except their primary diagnosed neurological condition (spinal cord injury)
Participants should not be pregnant
Participants should weigh less than 300 lbs
Participants should not have experienced signs of hip/knee pain during the past 2-3 weeks that limits mobility (i.e., reaching, walking, lifting, etc.)
Trial design
Design model
Single group
Treatments tested in this trial
Wearable Robotic Exoskeleton
Device* Participant preparation, placement of wearable sensors and monitoring, and wearable device fitting. * Lower-limb joint rotations and leg stretching protocol (40-60 minutes). The wearable exoskeleton and its control algorithm are evaluated to rotate leg joints and apply stretching similarly to the forces applied by nurses and caregivers when providing manual forces. Joint rotation and limb stretching is conducted while participants sit down (e.g., in a wheelchair, on a chair, on one side of a bed, or on a clinical mat) or lay down on a bed/mat. The protocol involves ankle plantarflexion and dorsiflexion, knee extension, hip flexion with the knee flexed, and toe flexion and extension (bilaterally) assisted by the exoskeleton, and each movement is repeated at a low-to-moderate rate of 10-30 cycles/minute. * Treadmilll and Overground Walking (60-90 minutes including rest periods) * Cool down (5-10 minutes)
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Robotic ExoskeletonExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
3D postures
3D postures will be assessed using the device, combining measurements of multiple joints in space
Time frame
Through study completion, an average of 24 weeks2
Joint angles
Hip and knee joint angles measured in degrees will be assessed using the device
Time frame
Through study completion, an average of 24 weeks3
Joint angular velocities
Hip and knee joint velocities measured in radians per second or degrees per second will be assessed using the device
Time frame
Through study completion, an average of 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
Syracuse University
Collaborator
Source ClinicalTrials.gov