Gait TrainingNCT00334230
Gait Training and Brain Changes in Stroke Patients
An observational study of Gait Training and Locomotion, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study, conducted in collaboration with the National Rehabilitation Hospital (NRH) in Washington, D.C., will look at changes in brain activation and brain responses that occur with gait (walking) training. Brain images and responses of healthy subjects are compared with those of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait Training, Locomotion
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2006to 21 Apr 2008
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stroke Patients
- May be eligible for this research study if they:
- qualified for participation in the NRH locomotor protocol
- are between 18 and 80 years old
- have not had any other strokes
- had a stroke more than 3 months ago
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- had a stroke that affected one side of the brain
- are able to perform the tasks required in the study with the paretic or non-paretic foot
- are willing and able to give consent
- Healthy Volunteers
- May be eligible for the research study if they:
- are between 18 and 80 years old
- are able to perform the tasks required in the study
- are willing and able to give consent
- a normal physical and neurological examination
Who cannot join
- Sub-acute stroke patients will be not be eligible for the study if they:
- are unable to perform the behavioral tasks with the non-paretic foot,
- have had more than one stroke,
- have a history of alcohol or drug abuse or severe language disturbances (aphasia)
- have uncontrolled medical problems, such as heart, lung or kidney disease, epilepsy or diabetes mellitus,
- are pregnant. Since the effects of MRI and TMS on fetal development are unknown, women of childbearing age will have pregnancy test prior to the study and pregnant women will be excluded.
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- have a cardiac pacemaker, intracardiac lines, implanted medication pumps, neural stimulators, metal in the cranium, with the exception or dental braces in the mouth.
- simultaneous participation in any other intervention protocol for stroke.
- have with serious cognitive deficits (defined as equivalent to a mini-mental state exam score (MMSE) of 23 or less)
- Healthy volunteers will not be eligible for the study if they:
- are unable to perform the tasks,
- have a history of alcohol or drug abuse or severe language disturbances or serious cognitive deficits,
- have uncontrolled medical problems, such as heart, lung or kidney disease, epilepsy or diabetes mellitus,
- are pregnant. Since the effects of MRI and TMS on fetal development are unknown, women of childbearing age will have pregnancy test prior to the study and pregnant women will be excluded.
- have a cardiac pacemaker, intracardiac lines, implanted medication pumps, neural stimulators, metal in the cranium except in the mouth, dental braces.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Mechanisms of Training Induced Improvements in Gait Function After Stroke
This study, conducted in collaboration with the National Rehabilitation Hospital (NRH) in Washington, D.C., will look at changes in brain activation and brain responses that occur with gait (walking) training. Brain images and responses of healthy subjects are compared with those of patients.
Healthy normal volunteers and people who have had a stroke within 3 months of starting the study may be eligible for this study. Candidates must be between 18 and 80 years of age, and patients must participate in NRH's walking study.
Read more
Stroke patients participate in all three study sessions described below. The first session takes place before patients start the NRH walking training study, the second session takes place at completion of the NRH walking study, and the third session takes place 3 months after completing the NRH study. Healthy control subjects complete only the procedures in session 3.
Session 1
Day 1: Neurological examination and questionnaire to evaluate memory and attention.
Day 2: Motor testing with transcranial magnetic stimulation (TMS). For this test, a wire coil is held on the subject's scalp. A brief electrical current passes through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions to help position the coil properly. The stimulation may cause a twitch in the leg muscles, and the subject may hear a click and feel a pulling sensation on the skin under the coil.
Session 2
Day 1: Functional MRI (fMRI). MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The subject lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. Scanning time varies from 20 minutes to 3 hours, with most scans lasting 45 and 90 minutes. Subjects may be asked to lie still for up to a few minutes at a time and to perform movements of their foot.
Day 2: motor testing with TMS.
Session 3
Day 1: fMRI
Day 2: motor testing with TMS
Read the detailed description
OBJECTIVES:
The purpose of this protocol is to study the mechanisms underlying the beneficial effects of locomotor training in hemiplegic patients. The locomotor training will be performed under an approved protocol already started at the National Rehabilitation Hospital (NRH). The overall goal of the NRH protocol is to determine whether goal-directed, robotic-assisted gait training is more effective than conventional gait training for facilitating the recovery of stable walking patterns in hemiparetic stroke patients. We will use functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS) to identify changes in neural networks involved in performance improvements associated with the locomoter training. The relative contribution of somatosensory cortices (SI, SII) to these performance improvements has not been studied. SI and SII have key roles in both storing and processing sensory information. Activity in the somatosensory cortex is significantly involved in controlling sensory input relevant to motor learning in health and disease. For example, stroke patients with decreased sensation exhibit less recovery than those with intact sensation. Sensory input is thought to play a crucial role in performance improvements associated with locomotor learning. Therefore, it is likely that SI and SII activity plays a major contributory role in training-dependent locomotor improvement after stroke. Electrophysiological measurements can provide important insights into sensorimotor integration processes in humans. Indeed, cortical facilitation induced by peripheral nerve afferent input is useful to probe sensorimotor interaction in health and disease. The specific hypotheses are that performance improvements with locomotor training will be associated with: (a) increased sensorimotor integration as expressed by facilitation in MEP size induced by peripheral nerve stimulation, and (b) greater processing in somatosensory regions, expressed as increased fMRI activation in ipsilesional SI and SII.
- Conditions
- Gait Training, Locomotion
- Keywords
- Functional Magnetic Resonance Imaging (fMRI), Transcranial Magnetic Stimulation (TMS), Locomotion, Cortical Reorganization, Rehabilitation, fMRI, Stroke, Healthy Volunteer, HV
- Medical subject headings
- Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2006 (estimated)
- Study start2 Jun 2006
- Study completion21 Apr 2008
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 Gait TrainingStudies 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
- Observational
- Enrolment
- 58 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334230
- Sponsor's protocol ID
- 060175
- Other IDs
- 06-N-0175
- Status last verified
- 21 Apr 2008
- First submitted
- 6 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Bayona NA, Bitensky J, Teasell R. Plasticity and reorganization of the uninjured brain. Top Stroke Rehabil. 2005 Summer;12(3):1-10. doi: 10.1310/A422-G91U-Q4HB-86XC.
PubMed 16110423
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Training Induced Improvements in Gait Function After Stroke
- ClinicalTrials.gov ID
- NCT00334230
- Acronym / sponsor ID
- 060175
- Conditions
- Gait Training, Locomotion
- Keywords
- Functional Magnetic Resonance Imaging (fMRI), Transcranial Magnetic Stimulation (TMS), Locomotion, Cortical Reorganization, Rehabilitation, fMRI, Stroke, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 2 Jun 2006
- Study completion
- 21 Apr 2008
- First posted
- 7 Jun 2006 (estimated)
- 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.
This study, conducted in collaboration with the National Rehabilitation Hospital (NRH) in Washington, D.C., will look at changes in brain activation and brain responses that occur with gait (walking) training. Brain images and responses of healthy subjects are compared with those of patients.
Healthy normal volunteers and people who have had a stroke within 3 months of starting the study may be eligible for this study. Candidates must be between 18 and 80 years of age, and patients must participate in NRH's walking study.
Stroke patients participate in all three study sessions described below. The first session takes place before patients start the NRH walking training study, the second session takes place at completion of the NRH walking study, and the third session takes place 3 months after completing the NRH study. Healthy control subjects complete only the procedures in session 3.
Session 1
Day 1: Neurological examination and questionnaire to evaluate memory and attention.
Day 2: Motor testing with transcranial magnetic stimulation (TMS). For this test, a wire coil is held on the subject's scalp. A brief electrical current passes through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions to help position the coil properly. The stimulation may cause a twitch in the leg muscles, and the subject may hear a click and feel a pulling sensation on the skin under the coil.
Session 2
Day 1: Functional MRI (fMRI). MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The subject lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. Scanning time varies from 20 minutes to 3 hours, with most scans lasting 45 and 90 minutes. Subjects may be asked to lie still for up to a few minutes at a time and to perform movements of their foot.
Day 2: motor testing with TMS.
Session 3
Day 1: fMRI
Day 2: motor testing with TMS
Detailed description
OBJECTIVES:
The purpose of this protocol is to study the mechanisms underlying the beneficial effects of locomotor training in hemiplegic patients. The locomotor training will be performed under an approved protocol already started at the National Rehabilitation Hospital (NRH). The overall goal of the NRH protocol is to determine whether goal-directed, robotic-assisted gait training is more effective than conventional gait training for facilitating the recovery of stable walking patterns in hemiparetic stroke patients. We will use functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS) to identify changes in neural networks involved in performance improvements associated with the locomoter training. The relative contribution of somatosensory cortices (SI, SII) to these performance improvements has not been studied. SI and SII have key roles in both storing and processing sensory information. Activity in the somatosensory cortex is significantly involved in controlling sensory input relevant to motor learning in health and disease. For example, stroke patients with decreased sensation exhibit less recovery than those with intact sensation. Sensory input is thought to play a crucial role in performance improvements associated with locomotor learning. Therefore, it is likely that SI and SII activity plays a major contributory role in training-dependent locomotor improvement after stroke. Electrophysiological measurements can provide important insights into sensorimotor integration processes in humans. Indeed, cortical facilitation induced by peripheral nerve afferent input is useful to probe sensorimotor interaction in health and disease. The specific hypotheses are that performance improvements with locomotor training will be associated with: (a) increased sensorimotor integration as expressed by facilitation in MEP size induced by peripheral nerve stimulation, and (b) greater processing in somatosensory regions, expressed as increased fMRI activation in ipsilesional SI and SII.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Stroke Patients
- qualified for participation in the NRH locomotor protocol
- are between 18 and 80 years old
- have not had any other strokes
- had a stroke more than 3 months ago
Key exclusion criteria (15 listed)
- are unable to perform the behavioral tasks with the non-paretic foot,
- have had more than one stroke,
- have a history of alcohol or drug abuse or severe language disturbances (aphasia)
- have uncontrolled medical problems, such as heart, lung or kidney disease, epilepsy or diabetes mellitus,
- are pregnant. Since the effects of MRI and TMS on fetal development are unknown, women of childbearing age will have pregnancy test prior to the study and pregnant women will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 16110423Bayona NA, Bitensky J, Teasell R. Plasticity and reorganization of the uninjured brain. Top Stroke Rehabil. 2005 Summer;12(3):1-10. doi: 10.1310/A422-G91U-Q4HB-86XC.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait Training and Locomotion, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 15 inclusion and 15 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 2 Jul 2017. 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. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00334230, 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 2 Jul 2017.