Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago
About this trial
Achieving functional ambulation post stroke continues to be a challenge for stroke survivors, clinicians, and researchers. In the effort to enhance outcomes of motor training, cortical priming using brain stimulation has emerged as a promising adjuvant to conventional rehabilitation. This project focuses on the development of a long term gait rehabilitation protocol using brain stimulation to improve walking outcomes in people with stroke. The project will also aim to understand the neural mechanisms that are associated with response to the intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age greater than 18 years
First ever monohemispheric stroke > 3 months since onset
Residual hemiparetic gait deficits (e.g. abnormal gait pattern)
Able to walk for 5 minutes at self-paced speed. Handheld assistive device is acceptable.
Disqualifiers
General exclusion criteria
Severe osteoporosis
Contracture-limiting range of motion of lower limb
Score of more than 2 on the Modified Ashworth Scale (indicating increased muscle tone through ankle range of motion)
Trial design
Design model
Parallel
Treatments tested in this trial
Transcranial direct current stimulation (tDCS)
Other intervention1 mA tDCS
Ankle motor training
Other interventionVisuomotor target tracking task
High intensity interval speed based treadmill training (HIISTT)
BehavioralEach treadmill session to include warm-up, high intensity speed-based intervals interleaved with active recovery, and cool down.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Priming+HIISTTExperimental treatment 3 interventions
Group B: Sham+HIISTTSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Walking speed with 10 meter walk test
Self-selected and fastest gait speed will be measured as the average of 3 trials of the 10-m walk test (10MWT).
Time frame
Change from baseline to immediately after training and baseline to 3 months follow upSecondary outcomes
1
Walking spatiotemporal characteristics with GAITRite walkway
Spatiotemporal parameters of walking will be assessed using a 7m long pressure sensitive mat (GAITRite walkway).
Time frame
Change from baseline to immediately after training and baseline to 3 months follow up2
Motor impairment with Fugl Meyer Lower Extremity Scale
Lower extremity impairment will be measured using the Fugl Meyer Lower Extremity Scale (FMLE), a series of tests of movement, reflex activity, coordination/speed, sensation, and range of motion. The maximum score is 34 and a high score indicates less impairment
Time frame
Change from baseline to immediately after training and baseline to 3 months follow up3
Walking endurance with 6-minute walk test
Walking endurance will be measured using the 6-Minute Walk test. Participants will walk as far as possible within 6 minutes.
Time frame
Change from baseline to immediately after training and baseline to 3 months follow up4
Ankle range of motion
Ankle range of motion will be measured using a wireless electrogoniometer affixed to the ankle.
Time frame
Change from baseline to immediately after training and baseline to 3 months follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
University of Maryland, College Park
Collaborator
Northwestern University
Collaborator
Source ClinicalTrials.gov