Health TrialsbyHealthPanel

Short-term Spinal Stimulation Effects in Cerebral Palsy

ConditionCerebral Palsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-65
SponsorUniversity of Washington

About this trial

This research study will examine the acute effects of non-invasive spinal stimulation on spasticity and walking in individuals with cerebral palsy. The hypothesis is that walking with spinal stimulation will lead to greater reductions in spasticity than walking without spinal stimulation. Additionally, it is hypothesized that the average step length and Gait Deviation Index will be higher while walking with spinal stimulation compared to walking without spinal stimulation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

have a diagnosis of spastic cerebral palsy or high likelihood of CP diagnosis

are 4-65 years of age

have spasticity in lower-extremity muscles

are at a functional Gross Motor Function Classification System (GMFCS) Level I-III

Disqualifiers

who have had lower-extremity surgery or injury in the prior 12 months

have had botulinum toxin injections in the prior 3 months

have had selective dorsal rhizotomy (SDR) in the past

have uncontrolled seizures

Trial design

Design model

Crossover

Treatments tested in this trial

  • Spinal Stimulation

    Device

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

  • Treadmill Walking

    Other intervention

    Participant will walk on a treadmill.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Spinal Stimulation First (AB Arm)Experimental treatment 2 interventions
Group B: No Spinal Stimulation First (BA Arm)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Modified Tardieu Scale of Spasticity

Change in quality of muscle reaction of the gastrocnemius assessed by the score on the Tardieu assessment. Lower score indicates less spasticity.

Time frame
End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.

Secondary outcomes

1

Step Length

From quantitative gait analysis step length is quantified as the average during the final minute of walking using gait analysis and markers on the foot.

Time frame
End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
2

Gait Deviation Index (GDI)

A multivariate metric derived from quantitative gait analysis that quantifies how much a gait cycle deviates from normative data. Average GDI calculated at the last 5 minutes of walking. Higher GDI indicates more normative walking.

Time frame
Last 5 minutes of treadmill walking during visit relative to baseline at start of walking.

Other outcomes

Sponsors and contacts

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

University of Washington

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov
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