Spinal Stimulation and Mobility Devices

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-70
SponsorUniversity of Washington

About this trial

This research study will combine non-invasive spinal stimulation with mobility devices to examine the acute impact of the individual and combined effects of these innovative techniques on mobility in children with cerebral palsy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

have a neurologic condition

are 4-70 years of age

have stable medical condition

can perform simple cued motor tasks and who can follow 2-3 step commands

Disqualifiers

have significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation.

have cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention

have a history of uncontrolled seizures

have unhealed fracture or other musculoskeletal impairment that might interfere with lower extremity rehabilitation or testing activities

Trial design

Design model

Single group

Treatments tested in this trial

  • Mobility Device

    Device

    Use of mobility device during session.

  • Spinal Stimulation

    Device

    A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lum

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Neurologic DisordersExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Muscle Coordination

Change in level of co-contraction between the plantarflexor and tibialis anterior muscles during the gait cycle monitored from electromyography recordings.

Time frame
Comparing first and last minute of walking on treadmill at each experimental session.

Secondary outcomes

1

Modified Ashworth Scale

Change in summed score of spasticity from lower-extremity muscles. Lower values indicate less spasticity.

Time frame
Physical exam conducted at the beginning and end of each experimental session.
2

Plantarflexor Muscle Strength

Change in maximum voluntary contraction level of the plantarflexor muscles taken as the average of three trials where the participant exerts the maximum amount of force measured from a handheld dynamometer with verbal encouragement.

Time frame
Physical exam conducted at the beginning and end of experimental session.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

Seattle Children's Hospital

Collaborator