StrokeNCT03492229
Cortical Priming to Optimize Gait Rehabilitation Post Stroke
A study testing tDCS, AMT and Treadmill training in people with Stroke, run by University of Illinois Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- tDCS, AMT and Treadmill training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2014to 15 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Illinois at Chicago
Chicago, Illinois, 60612-7246
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSOther
1 mA of tDCS
AMTOther
Ankle motor training
Treadmill trainingBehavioural
High intensity treadmill training
| Study group | Role | What they receive |
|---|---|---|
| tDCS+AMT | Experimental | TDCS in combination with movement training before treadmill training Receives: Other: tDCS; Other: AMT; Behavioral: Treadmill training |
| tDCS | Active comparator | tDCS only before treadmill training Receives: Other: tDCS; Behavioral: Treadmill training |
| AMT | Active comparator | Movement training only before treadmill training Receives: Other: AMT; Behavioral: Treadmill training |
| Control | Sham comparator | No priming before treadmill training Receives: Behavioral: Treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline to immediately after training and baseline to 3 months follow up
Secondary outcomes (4)
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.
Measured: Change from baseline to immediately after training and baseline to 3 months follow up
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.
Measured: Change from baseline to immediately after training and baseline to 3 months follow up
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.
Measured: Change from baseline to immediately after training and baseline to 3 months follow up
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.
Measured: Change from baseline to immediately after training and baseline to 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 Jan 2014
- Primary completion31 Oct 2019
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sangeetha Madhavan, University of Illinois Chicago
- Investigators
- Sangeetha Madhavan, Principal investigator, UIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492229
- Sponsor's protocol ID
- 2011-0676
- Other IDs
- R01HD075777
- Status last verified
- Aug 2022
- First submitted
- 9 Mar 2018
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32799922
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Priming to Optimize Gait Rehabilitation Post Stroke
- ClinicalTrials.gov ID
- NCT03492229
- Acronym / sponsor ID
- 2011-0676
- Conditions
- Stroke
- Keywords
- Gait, Brain stimulation, tDCS, Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tDCS+AMT | Experimental | Other: tDCS, Other: AMT, Behavioral: Treadmill trainingTDCS in combination with movement training before treadmill training |
| tDCS | Active comparator | Other: tDCS, Behavioral: Treadmill trainingtDCS only before treadmill training |
| AMT | Active comparator | Other: AMT, Behavioral: Treadmill trainingMovement training only before treadmill training |
| Control | Sham comparator | Behavioral: Treadmill trainingNo priming before treadmill training |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS1 mA of tDCS | Other | tDCS, tDCS+AMT |
| AMTAnkle motor training | Other | AMT, tDCS+AMT |
| Treadmill trainingHigh intensity treadmill training | Behavioural | AMT, Control, tDCS, tDCS+AMT |
Primary outcome
Change in gait speed using 10 meter walk test
Time frame: Change from baseline to immediately after training and baseline to 3 months follow up
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).
4 secondary outcomes
Change in 6 minute walk test
Time frame: Change from baseline to immediately after training and baseline to 3 months follow up
Change in Berg Balance Scale
Time frame: Change from baseline to immediately after training and baseline to 3 months follow up
Change in Quality of life measures
Time frame: Change from baseline to immediately after training and baseline to 3 months follow up
Change in cortical excitability of leg muscles using TMS
Time frame: Change from baseline to immediately after training and baseline to 3 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Derived from this study: PubMed 32799922Madhavan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangeetha Madhavan principal investigator
UIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS, AMT and Treadmill training in people with Stroke, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gait speed using 10 meter walk test (time frame: Change from baseline to immediately after training and baseline to 3 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03492229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.