Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Priming+HIISTT

Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training

Group Type EXPERIMENTAL

Transcranial direct current stimulation (tDCS)

Intervention Type OTHER

1 mA tDCS

Ankle motor training

Intervention Type OTHER

Visuomotor target tracking task

High intensity interval speed based treadmill training (HIISTT)

Intervention Type BEHAVIORAL

Each treadmill session to include warm-up, high intensity speed-based intervals interleaved with active recovery, and cool down.

Sham+HIISTT

Sham tDCS before high intensity interval speed based treadmill training

Group Type SHAM_COMPARATOR

High intensity interval speed based treadmill training (HIISTT)

Intervention Type BEHAVIORAL

Each treadmill session to include warm-up, high intensity speed-based intervals interleaved with active recovery, and cool down.

Interventions

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Transcranial direct current stimulation (tDCS)

1 mA tDCS

Intervention Type OTHER

Ankle motor training

Visuomotor target tracking task

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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

* 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

* Skin hypersensitivity
* History of contact dermatitits
* History of allodynia and/or hyperalgesia
* Any other skin or scalp condition that could be aggravated by tDCS

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No