StrokeABC of WalkingNCT02132650
Rehabilitating Corticospinal Control of Walking
A study testing ACC training and SS training in people with Stroke, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
The VHA estimates that over 15,000 Veterans incur a stroke each year. As the population of older Veterans grows, stroke will become an increasingly important problem to the VHA. Recovery of walking function is the most common goal of stroke survivors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- ACC training and SS training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jun 2014to 31 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- occurrence of a single unilateral stroke within the previous 6-18 months (verified by MRI or CT from medical record)
- living in the community and able to travel to training and assessment sites
- approval of participation by primary care physician
- age 18 - 80 years
- lower extremity paresis indicated by Fugl-Meyer Assessment Score < 30
- deficit in at least one "synergy" subcategory (II - IV) of the Fugl-Meyer Assessment
Show all 10Show fewer
- self-selected 10m gait speed of 0.4 - 0.8 m/s (with or without an ankle/foot orthosis or cane)
- able to provide informed consent
- willingness to be randomized to either intervention group
- written approval by primary care physician
Who cannot join
- neurological disorder or injury (other than stroke) such as Parkinson' s disease or spinal cord injury
- severe arthritis, such as awaiting joint replacement, that would interfere with study participation
- cardiovascular disease (congestive heart failure, significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator, uncontrolled angina)
- myocardial infarction or major heart surgery in the previous year
- cancer requiring treatment in the past three years, except for nonmelanoma skin cancers and other cancers having an excellent prognosis (e.g., early stage breast or prostate cancer)
- lung disease requiring use of corticosteroids or supplemental oxygen
Show all 22Show fewer
- renal disease requiring dialysis
- current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
- Mini-Mental State Examination (MMSE) score <23
- major depression (Patient Health Questionnaire score > 10)
- severe obesity (body mass index > 35)
- uncontrolled hypertension (systolic > 200 mmHg and/or diastolic > 110 mmHg)
- uncontrolled diabetes with recent diabetic coma or frequent hypoglycemia
- bone fracture or joint replacement in the previous six months
- diagnosis of a terminal illness
- current participation in physical therapy or cardiopulmonary rehabilitation
- significant visual impairment affecting capability to gauge movement accuracy
- previous enrollment in a clinical trial for recovery of walking function
- current enrollment in any clinical trial
- planning to relocate out of the greater Gainesville FL area during the study period
- unable to communicate sufficiently with study personnel
- clinical judgment regarding safety or noncompliance
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
Brooks Rehabilitation Hospital
Jacksonville, Florida, 32216
About this study
Official title: Rehabilitation of Corticospinal Control of Walking Following Stroke
The VHA estimates that over 15,000 Veterans incur a stroke each year. As the population of older Veterans grows, stroke will become an increasingly important problem to the VHA. Recovery of walking function is the most common goal of stroke survivors. The proposed study will test whether training with accurate walking tasks to engage the damaged supraspinal motor pathways is more effective than training with steady state walking. The investigators expect that training accurate tasks will be more effective, thereby improving walking function of Veteran stroke survivors and reducing the burden of care placed on families and on the VHA. Furthermore, this rehabilitation approach can be accomplished at comparable cost to existing rehabilitation approaches, which is important given that the VHA invests $88 million per year toward outpatient care, including physical rehabilitation, in the first six months after stroke. This research also has implications for rehabilitation of other neurologically injured populations, including traumatic brain injury and incomplete spinal cord injury.
Read the detailed description
Current approaches for rehabilitation of walking following stroke do not sufficiently restore mobility function. For instance, fewer than 50% of individuals with stroke-induced walking dysfunction recover the ability to walk independently in the community. New breakthroughs in rehabilitation are needed that will target the motor impairments responsible for poor walking function in individuals post-stroke. Functional recovery can occur in response to task-specific neuroplasticity of damaged brain circuitry. The corticospinal tract is an important target for neuroplasticity because it plays an important role for control of walking in humans. Research has shown that, compared to steady state walking, accurate gait modification (ACC) tasks are a potent behavioral stimulus for activating the corticospinal tract. Therefore, the investigators propose that training with ACC tasks (e.g., obstacle crossing/avoidance, accurate foot placement, etc.) may be superior to training with steady state walking (SS) for eliciting corticospinal neuroplasticity and recovery of walking function. Most rehabilitation paradigms have previously focused on SS training. This is largely because therapists consider it premature to progress to ACC tasks when persistent deficits of steady state walking still remain. However, this reasoning might be counter-productive, because training only steady state walking may not sufficiently stimulate neuro-plasticity of the damaged corticospinal pathway. In contrast, ACC training is specifically designed to stimulate corticospinal neuroplasticity. Importantly, since ACC training targets a central mechanism, its benefits are expected to generalize across walking conditions. Furthermore, it is expected to benefit most stroke survivors who possess at least a minimal residual capability to activate the corticospinal tract. ACC training also provides an opportunity to practice tasks that are analogous to challenges encountered in the home and community environments. Accordingly, there is strong mechanistic and practical rationale for ACC training.
A number of earlier studies have cumulatively established exciting preliminary evidence showing that walking function is enhanced by training with ACC tasks. However, no prior study has been specifically designed and sufficiently powered to determine the extent to which the "accurate gait modification" ingredient is crucial for recovery of walking function. Also not known is the extent to which ACC training reduces the neural impairments underlying poor walking function. The central hypothesis of this study is that ACC training will be superior to SS training for increasing walking function and for reducing underlying neural control of the paretic leg in adults with post-stroke hemiparesis. Each intervention will involve twelve weeks of training, 3 days per week (36 sessions total), and will emphasize the motor learning principles of high intensity, repetition and task-specificity. Assessments will be conducted immediately pre-intervention, immediately post-intervention and at a follow-up session 3 months later. Walking function will be measured in the lab and in the "real world". Neural impairment measures will include electromyography-based measures of inter-muscular coordination and corticospinal drive.
The investigators expect that the benefits of ACC training will justify larger randomized controlled trials to optimize the use of ACC training, including timing relative to stroke, combination with other therapeutic approaches, and identifying individuals who are most likely to benefit from this approach. This research is expected to enhance walking function in stroke survivors, including for the 15,000 Veterans who suffer a stroke each year.
- Conditions
- Stroke
- Being tested
- ACC training, SS training
- Keywords
- Rehabilitation, Walking, Motor skills disorders, Electromyography
- Medical subject headings
- Stroke, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACC trainingBehavioural
Rehabilitation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc.
SS trainingBehavioural
Rehabilitation of walking using typical steady state (SS) walking. Conducted overground and on treadmill. 36 sessions of training conducted over the course of 12 weeks. Each session lasts about 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| ACC | Experimental | Rehabilitation of walking using accurate (ACC) walking tasks Receives: Behavioral: ACC training |
| SS | Active comparator | Rehabilitation of walking using typical steady state (SS) walking Receives: Behavioral: SS training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walk Speed From Pre-Intervention (0 Months) to Post-Intervention (3 Months)
self selected (preferred) steady state walking speed
Measured: assessed pre-intervention (0 months) and post-intervention (3 months)
Change in Walk Speed From Pre-Intervention (0 Months) to Follow-Up (6 Months)
self selected (preferred) steady state walking speed
Measured: assessed pre-intervention (0 months) and follow-up (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study start2 Jun 2014
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Florida, Brooks Rehabilitation
- Responsible party
- Sponsor
- Investigators
- David J. Clark, DSc, Principal investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132650
- Sponsor's protocol ID
- B1149-R
- Acronym
- ABC of Walking
- Status last verified
- Apr 2022
- First submitted
- 23 Apr 2014
- Last updated
- 5 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clark DJ, Rose DK, Butera KA, Hoisington B, DeMark L, Chatterjee SA, Hawkins KA, Otzel DM, Skinner JW, Christou EA, Wu SS, Fox EJ. Rehabilitation with accurate adaptability walking tasks or steady state walking: A randomized clinical trial in adults post-stroke. Clin Rehabil. 2021 Aug;35(8):1196-1206. doi: 10.1177/02692155211001682. Epub 2021 Mar 16.
PubMed 33722075Chatterjee SA, Daly JJ, Porges EC, Fox EJ, Rose DK, McGuirk TE, Otzel DM, Butera KA, Clark DJ. Mobility Function and Recovery After Stroke: Preliminary Insights From Sympathetic Nervous System Activity. J Neurol Phys Ther. 2018 Oct;42(4):224-232. doi: 10.1097/NPT.0000000000000238.
PubMed 30138228
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Corticospinal Control of Walking Following Stroke
- ClinicalTrials.gov ID
- NCT02132650
- Acronym / sponsor ID
- ABC of Walking / B1149-R
- Conditions
- Stroke
- Keywords
- Rehabilitation, Walking, Motor skills disorders, Electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Florida, Brooks Rehabilitation
- Study start
- 2 Jun 2014 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Posted 9 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The VHA estimates that over 15,000 Veterans incur a stroke each year. As the population of older Veterans grows, stroke will become an increasingly important problem to the VHA. Recovery of walking function is the most common goal of stroke survivors. The proposed study will test whether training with accurate walking tasks to engage the damaged supraspinal motor pathways is more effective than training with steady state walking. The investigators expect that training accurate tasks will be more effective, thereby improving walking function of Veteran stroke survivors and reducing the burden of care placed on families and on the VHA. Furthermore, this rehabilitation approach can be accomplished at comparable cost to existing rehabilitation approaches, which is important given that the VHA invests $88 million per year toward outpatient care, including physical rehabilitation, in the first six months after stroke. This research also has implications for rehabilitation of other neurologically injured populations, including traumatic brain injury and incomplete spinal cord injury.
Detailed description
Current approaches for rehabilitation of walking following stroke do not sufficiently restore mobility function. For instance, fewer than 50% of individuals with stroke-induced walking dysfunction recover the ability to walk independently in the community. New breakthroughs in rehabilitation are needed that will target the motor impairments responsible for poor walking function in individuals post-stroke. Functional recovery can occur in response to task-specific neuroplasticity of damaged brain circuitry. The corticospinal tract is an important target for neuroplasticity because it plays an important role for control of walking in humans. Research has shown that, compared to steady state walking, accurate gait modification (ACC) tasks are a potent behavioral stimulus for activating the corticospinal tract. Therefore, the investigators propose that training with ACC tasks (e.g., obstacle crossing/avoidance, accurate foot placement, etc.) may be superior to training with steady state walking (SS) for eliciting corticospinal neuroplasticity and recovery of walking function. Most rehabilitation paradigms have previously focused on SS training. This is largely because therapists consider it premature to progress to ACC tasks when persistent deficits of steady state walking still remain. However, this reasoning might be counter-productive, because training only steady state walking may not sufficiently stimulate neuro-plasticity of the damaged corticospinal pathway. In contrast, ACC training is specifically designed to stimulate corticospinal neuroplasticity. Importantly, since ACC training targets a central mechanism, its benefits are expected to generalize across walking conditions. Furthermore, it is expected to benefit most stroke survivors who possess at least a minimal residual capability to activate the corticospinal tract. ACC training also provides an opportunity to practice tasks that are analogous to challenges encountered in the home and community environments. Accordingly, there is strong mechanistic and practical rationale for ACC training.
A number of earlier studies have cumulatively established exciting preliminary evidence showing that walking function is enhanced by training with ACC tasks. However, no prior study has been specifically designed and sufficiently powered to determine the extent to which the "accurate gait modification" ingredient is crucial for recovery of walking function. Also not known is the extent to which ACC training reduces the neural impairments underlying poor walking function. The central hypothesis of this study is that ACC training will be superior to SS training for increasing walking function and for reducing underlying neural control of the paretic leg in adults with post-stroke hemiparesis. Each intervention will involve twelve weeks of training, 3 days per week (36 sessions total), and will emphasize the motor learning principles of high intensity, repetition and task-specificity. Assessments will be conducted immediately pre-intervention, immediately post-intervention and at a follow-up session 3 months later. Walking function will be measured in the lab and in the "real world". Neural impairment measures will include electromyography-based measures of inter-muscular coordination and corticospinal drive.
The investigators expect that the benefits of ACC training will justify larger randomized controlled trials to optimize the use of ACC training, including timing relative to stroke, combination with other therapeutic approaches, and identifying individuals who are most likely to benefit from this approach. This research is expected to enhance walking function in stroke survivors, including for the 15,000 Veterans who suffer a stroke each year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACC | Experimental | Behavioral: ACC trainingRehabilitation of walking using accurate (ACC) walking tasks |
| SS | Active comparator | Behavioral: SS trainingRehabilitation of walking using typical steady state (SS) walking |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- occurrence of a single unilateral stroke within the previous 6-18 months (verified by MRI or CT from medical record)
- living in the community and able to travel to training and assessment sites
- approval of participation by primary care physician
- age 18 - 80 years
- lower extremity paresis indicated by Fugl-Meyer Assessment Score < 30
Key exclusion criteria (22 listed)
- neurological disorder or injury (other than stroke) such as Parkinson' s disease or spinal cord injury
- severe arthritis, such as awaiting joint replacement, that would interfere with study participation
- cardiovascular disease (congestive heart failure, significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator, uncontrolled angina)
- myocardial infarction or major heart surgery in the previous year
- cancer requiring treatment in the past three years, except for nonmelanoma skin cancers and other cancers having an excellent prognosis (e.g., early stage breast or prostate cancer)
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 |
|---|---|---|
| ACC trainingRehabilitation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc. | Behavioural | ACC |
| SS trainingRehabilitation of walking using typical steady state (SS) walking. Conducted overground and on treadmill. 36 sessions of training conducted over the course of 12 weeks. Each session lasts about 1 hour. | Behavioural | SS |
Primary outcome
Change in Walk Speed From Pre-Intervention (0 Months) to Post-Intervention (3 Months)
Time frame: assessed pre-intervention (0 months) and post-intervention (3 months)
self selected (preferred) steady state walking speed
Change in Walk Speed From Pre-Intervention (0 Months) to Follow-Up (6 Months)
Time frame: assessed pre-intervention (0 months) and follow-up (6 months)
self selected (preferred) steady state walking speed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33722075Clark DJ, Rose DK, Butera KA, Hoisington B, DeMark L, Chatterjee SA, Hawkins KA, Otzel DM, Skinner JW, Christou EA, Wu SS, Fox EJ. Rehabilitation with accurate adaptability walking tasks or steady state walking: A randomized clinical trial in adults post-stroke. Clin Rehabil. 2021 Aug;35(8):1196-1206. doi: 10.1177/02692155211001682. Epub 2021 Mar 16.
- Derived from this study: PubMed 30138228Chatterjee SA, Daly JJ, Porges EC, Fox EJ, Rose DK, McGuirk TE, Otzel DM, Butera KA, Clark DJ. Mobility Function and Recovery After Stroke: Preliminary Insights From Sympathetic Nervous System Activity. J Neurol Phys Ther. 2018 Oct;42(4):224-232. doi: 10.1097/NPT.0000000000000238.
- 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.
David J. Clark, DSc principal investigator
North Florida/South Georgia Veterans Health System, Gainesville, FL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACC training and SS training in people with Stroke, run by VA Office of Research and Development at 2 sites 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 10 inclusion and 22 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 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Walk Speed From Pre-Intervention (0 Months) to Post-Intervention (3 Months) (time frame: assessed pre-intervention (0 months) and post-intervention (3 months)). The study lists 2 primary outcomes in all. 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 NCT02132650, which also lists 2 linked publications.
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 5 May 2022.