Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal

Stroke Clinical Trial

Official title:

Cortical Priming to Optimize Gait Rehabilitation: Renewal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04477330
• Other study ID #: 2020-0502
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: University of Illinois at Chicago
• Contact: Sangeetha Madhavan
• Phone: 3123552517
• Email: smadhava[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• Walking speed lesser than 1.2 m/s

• Lower limb Fugl-Meyer Motor score between 15-30

• At least 5 deg of ankle dorsiflexion necessary to perform the ankle-tracking task

Exclusion Criteria:

• 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)

• Uncontrolled anti-spasticity medications during the study period

• Score less than 6 on the Fugl-Meyer Sensory Assessment Scale for the Lower Limb

• Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)

• Unhealed decubiti, persistent infection

• Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE)<21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the ankle-tracking task.

• Lesions involving the brainstem and cerebellum

• Failure to pass the graded exercise stress test

TMS exclusion criteria

• Implanted cardiac pacemaker

• Metal implants in the head or face

• Unexplained, recurring headaches

• History of seizures or epilepsy

• Currently under medication that could increase motor excitability and lower seizure threshold

• Skull abnormalities or fractures

• Concussion within the last 6 months

• Currently pregnant

tDCS exclusion criteria

• Skin hypersensitivity

• History of contact dermatitits

• History of allodynia and/or hyperalgesia

• Any other skin or scalp condition that could be aggravated by tDCS

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Transcranial direct current stimulation (tDCS)
1 mA tDCS
• Ankle motor training
Visuomotor target tracking task

Behavioral:
• High intensity interval speed based treadmill training (HIISTT)
Each treadmill session to include warm-up, high intensity speed-based intervals interleaved with active recovery, and cool down.

Locations

Country	Name	City	State
United States	Physical Therapy	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Northwestern University, University of Maryland, College Park

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline to immediately after training and baseline to 3 months follow up
Secondary	Walking spatiotemporal characteristics with GAITRite walkway	Spatiotemporal parameters of walking will be assessed using a 7m long pressure sensitive mat (GAITRite walkway).	Change from baseline to immediately after training and baseline to 3 months follow up
Secondary	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	Change from baseline to immediately after training and baseline to 3 months follow up
Secondary	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.	Change from baseline to immediately after training and baseline to 3 months follow up
Secondary	Ankle range of motion	Ankle range of motion will be measured using a wireless electrogoniometer affixed to the ankle.	Change from baseline to immediately after training and baseline to 3 months follow up
Secondary	Ankle motor control	The participant will track a computer-generated sinusoidal target with ankle dorsiflexion and plantarflexion in a custom-built ankle-tracking device. Accuracy of tracking the target with ankle motion will be calculated.	Change from baseline to immediately after training and baseline to 3 months follow up
Secondary	Balance with mini Balance Evaluations Systems Test (miniBESTest)	Balance will be tested with the Mini-BESTest, involving 14 different tasks to challenge balance.	Change from baseline to immediately after training and baseline to 3 months follow up.
Secondary	Aerobic capacity	Cardiopulmonary exercise tests will be performed on a motorized treadmill following an individualized protocol using standard procedures. Measures relating to peak oxygen consumption (VO2 max) will be calculated.	Change from baseline to immediately after training.
Secondary	Quality of Life with EuroQol-5D (EQ-5D)	Quality of life will be measured with the EuroQol-5D (EQ-5D), a questionnaire with questions designed to assess aspects of quality of life.	Change from baseline to immediately after training.
Secondary	Disability with Modified Rankin Scale	Global disability will be measured with the modified Rankin Scale, a simple 0-6 rating scale.	Change from baseline to immediately after training and baseline to 3 months follow up.
Secondary	Community ambulation with wearable sensors	Daily ambulation will be assessed using an accelerometer.	Change from baseline to immediately after training.
Secondary	Serum brain derived neurotrophic growth factor (BDNF)	5 ml of blood will be collected from a vein in the participants' arms	Change from baseline to immediately after training.
Secondary	Corticomotor excitability using transcranial magnetic stimulation	Corticomotor excitability of the paretic and non-paretic lower limb muscles such as the tibialis anterior and soleus muscle representations will be measured with single pulse transcranial magnetic stimulation (TMS).	Change from baseline to immediately after training and baseline to 3 months follow up.
Secondary	Cognitive function using Mini Mental Screening Examination	30-point questionnaire used to capture orientation, attention, memory and language.	Change from baseline to immediately after training and baseline to 3 months follow up.
Secondary	Depression using Patient Health Questionnaire-9 (PHQ-9)	The 9-point questionnaire is used to measure degree of depression.	Change from baseline to immediately after training and baseline to 3 months follow up.
Secondary	Modified Ashworth Scale	The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion,	Change from baseline to immediately after training and baseline to 3 months follow up.