Cortical Priming to Optimize Gait Rehabilitation Post Stroke

NCT ID: NCT03492229

Last Updated: 2022-08-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2020-08-15

Brief Summary

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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.

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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tDCS+AMT

TDCS in combination with movement training before treadmill training

Group Type EXPERIMENTAL

tDCS

Intervention Type OTHER

1 mA of tDCS

AMT

Intervention Type OTHER

Ankle motor training

Treadmill training

Intervention Type BEHAVIORAL

High intensity treadmill training

tDCS

tDCS only before treadmill training

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type OTHER

1 mA of tDCS

Treadmill training

Intervention Type BEHAVIORAL

High intensity treadmill training

AMT

Movement training only before treadmill training

Group Type ACTIVE_COMPARATOR

AMT

Intervention Type OTHER

Ankle motor training

Treadmill training

Intervention Type BEHAVIORAL

High intensity treadmill training

Control

No priming before treadmill training

Group Type SHAM_COMPARATOR

Treadmill training

Intervention Type BEHAVIORAL

High intensity treadmill training

Interventions

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tDCS

1 mA of tDCS

Intervention Type OTHER

AMT

Ankle motor training

Intervention Type OTHER

Treadmill training

High intensity treadmill training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Sangeetha Madhavan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sangeetha Madhavan

Role: PRINCIPAL_INVESTIGATOR

UIC

Locations

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The University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Madhavan S, Cleland BT, Sivaramakrishnan A, Freels S, Lim H, Testai FD, Corcos DM. Cortical priming strategies for gait training after stroke: a controlled, stratified trial. J Neuroeng Rehabil. 2020 Aug 17;17(1):111. doi: 10.1186/s12984-020-00744-9.

Reference Type DERIVED
PMID: 32799922 (View on PubMed)

Other Identifiers

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R01HD075777

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011-0676

Identifier Type: -

Identifier Source: org_study_id

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