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Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS)
Ankle motor training
High intensity interval speed based treadmill training (HIISTT)
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring tDCS, Walking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Priming+HIISTT

Sham+HIISTT

Arm Description

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

Sham tDCS before high intensity interval speed based treadmill training

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Walking spatiotemporal characteristics with GAITRite walkway
Spatiotemporal parameters of walking will be assessed using a 7m long pressure sensitive mat (GAITRite walkway).
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
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.
Ankle range of motion
Ankle range of motion will be measured using a wireless electrogoniometer affixed to the ankle.
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.
Balance with mini Balance Evaluations Systems Test (miniBESTest)
Balance will be tested with the Mini-BESTest, involving 14 different tasks to challenge balance.
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.
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.
Disability with Modified Rankin Scale
Global disability will be measured with the modified Rankin Scale, a simple 0-6 rating scale.
Community ambulation with wearable sensors
Daily ambulation will be assessed using an accelerometer.
Serum brain derived neurotrophic growth factor (BDNF)
5 ml of blood will be collected from a vein in the participants' arms
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).
Cognitive function using Mini Mental Screening Examination
30-point questionnaire used to capture orientation, attention, memory and language.
Depression using Patient Health Questionnaire-9 (PHQ-9)
The 9-point questionnaire is used to measure degree of depression.
Modified Ashworth Scale
The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion,

Full Information

First Posted
July 9, 2020
Last Updated
January 31, 2023
Sponsor
University of Illinois at Chicago
Collaborators
University of Maryland, College Park, Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04477330
Brief Title
Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal
Official Title
Cortical Priming to Optimize Gait Rehabilitation: Renewal
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
University of Maryland, College Park, Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
tDCS, Walking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Priming+HIISTT
Arm Type
Experimental
Arm Description
Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training
Arm Title
Sham+HIISTT
Arm Type
Sham Comparator
Arm Description
Sham tDCS before high intensity interval speed based treadmill training
Intervention Type
Other
Intervention Name(s)
Transcranial direct current stimulation (tDCS)
Intervention Description
1 mA tDCS
Intervention Type
Other
Intervention Name(s)
Ankle motor training
Intervention Description
Visuomotor target tracking task
Intervention Type
Behavioral
Intervention Name(s)
High intensity interval speed based treadmill training (HIISTT)
Intervention Description
Each treadmill session to include warm-up, high intensity speed-based intervals interleaved with active recovery, and cool down.
Primary Outcome Measure Information:
Title
Walking speed with 10 meter walk test
Description
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 up
Secondary Outcome Measure Information:
Title
Walking spatiotemporal characteristics with GAITRite walkway
Description
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 up
Title
Motor impairment with Fugl Meyer Lower Extremity Scale
Description
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 up
Title
Walking endurance with 6-minute walk test
Description
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 up
Title
Ankle range of motion
Description
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 up
Title
Ankle motor control
Description
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.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up
Title
Balance with mini Balance Evaluations Systems Test (miniBESTest)
Description
Balance will be tested with the Mini-BESTest, involving 14 different tasks to challenge balance.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up.
Title
Aerobic capacity
Description
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.
Time Frame
Change from baseline to immediately after training.
Title
Quality of Life with EuroQol-5D (EQ-5D)
Description
Quality of life will be measured with the EuroQol-5D (EQ-5D), a questionnaire with questions designed to assess aspects of quality of life.
Time Frame
Change from baseline to immediately after training.
Title
Disability with Modified Rankin Scale
Description
Global disability will be measured with the modified Rankin Scale, a simple 0-6 rating scale.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up.
Title
Community ambulation with wearable sensors
Description
Daily ambulation will be assessed using an accelerometer.
Time Frame
Change from baseline to immediately after training.
Title
Serum brain derived neurotrophic growth factor (BDNF)
Description
5 ml of blood will be collected from a vein in the participants' arms
Time Frame
Change from baseline to immediately after training.
Title
Corticomotor excitability using transcranial magnetic stimulation
Description
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).
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up.
Title
Cognitive function using Mini Mental Screening Examination
Description
30-point questionnaire used to capture orientation, attention, memory and language.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up.
Title
Depression using Patient Health Questionnaire-9 (PHQ-9)
Description
The 9-point questionnaire is used to measure degree of depression.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up.
Title
Modified Ashworth Scale
Description
The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion,
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sangeetha Madhavan
Phone
3123552517
Email
smadhava@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangeetha Madhavan
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Therapy
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sangeetha Madhavan
Email
brainlab@uic.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal

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