Cortical Priming to Optimize Gait Rehabilitation Post Stroke

Stroke Clinical Trial

Official title:

Cortical Priming to Optimize Gait Rehabilitation Post Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492229
• Other study ID #: 2011-0676
• Secondary ID: R01HD075777
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: August 15, 2020

Study information

• Verified date: August 2022
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Over four million stroke survivors currently living in the United States are unable to walk independently in the community. To increase the effectiveness of gait rehabilitation, it is critical to develop therapies that are based on an understanding of brain adaptations that occur after stroke. This project will be the first step towards the development of a novel therapeutic approach using brain stimulation to increase walking capacity in stroke survivors and understand the neural mechanisms that are associated with impairment and functional recovery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 15, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 50 - 80 years
• First ever monohemispheric stroke > 6 months since onset
• Residual hemiparetic gait deficits
• Able to walk without an ankle orthotic for 5 minutes at self-paced speed. Handheld assistive device is acceptable.

Exclusion Criteria:

• Severe osteoporosis
• Contracture-limiting range of motion of lower limb
• Uncontrolled anti-spasticity medications during the study period
• Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)
• Unhealed decubiti, persistent infection
• Significant cognitive or communication impairment (MMSE <21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the tracking task.
• Lesions pertaining to the brainstem and cerebellum

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• tDCS
1 mA of tDCS
• AMT
Ankle motor training

Behavioral:
• Treadmill training
High intensity treadmill training

Locations

Country	Name	City	State
United States	The University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gait speed using 10 meter walk test	10-meter walk test: Gait speed will be measured as the average of 3 trials of the 10-m walk test. Participants will be asked to walk at their normal comfortable pace to cover a distance of 10 meters without an AFO (handheld assistive device is acceptable if needed).	Change from baseline to immediately after training and baseline to 3 months follow up
Secondary	Change in 6 minute walk test	The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants will be asked to walk at their normal pace for 6 minutes.	Change from baseline to immediately after training and baseline to 3 months follow up
Secondary	Change in Berg Balance Scale	Balance will be measured using the Berg Balance Scale. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. Tasks such as standing with eyes closed, one leg stance etc are included.	Change from baseline to immediately after training and baseline to 3 months follow up
Secondary	Change in Quality of life measures	QOL will be measured with the Stroke Impact Scale (SIS). The SIS is a stroke-specific self-reported health status measure.	Change from baseline to immediately after training and baseline to 3 months follow up
Secondary	Change in cortical excitability of leg muscles using TMS	Transcranial magnetic stimulation will be used to measure contralateral and ipsilateral corticospinal excitability of the paretic tibialis anterior (TA) using the protocol previously published by the PI Dr. Madhavan.	Change from baseline to immediately after training and baseline to 3 months follow up