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Conventional therapies do not restore normal gait for many stroke survivors. The long-term goal of this work is to restore volitional lower limb motor control and gait following stroke. In our prior work, we demonstrated that it was feasible to provide a clinically operated, combined treatment of body weight supported treadmill training alone (BWSTT) + functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM).
Specific Aims and Hypothesis The purpose or Specific Aim of the study is to test the feasibility and gait training potential of combining the Lokomat and FNS-IM for stroke survivors. Given the feasibility of our clinically operated combination of BWSTT + FNS-IM, we propose to test the feasibility of the combination of Lokomat + FNS-IM.
Hypothesis I. It is feasible to utilize a clinically operated combination of Lokomat + functional neuromuscular stimulation (FNS) with intramuscular (IM) electrodes (FNS-IM).
Treatment Procedures. The subjects will be treated for three months, four sessions/week (for a total of 48 treatment visits). A given session will be 1 hrs, with the time divided into thirds as follows: 1) hr coordination exercise; 2) hr over ground gait training; and 3) hr Lokomat gait training. FNS-IM will be used in all three aspects of the protocol, unless the subject is capable of volitionally executing a given movement or gait component. Population. The subjects will be chronic stroke survivors (>6 months after the stroke).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | stroke |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gait Robot | Device | gait training with the use of a gait robot |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. | Observational Gait components during stance and swing phase, for pelvis, hip, knee, and ankle for each of the six participants was observed during the following conditions: Gait Robot-alone, FES-alone, and combined Gait Robot and FES. | visit 48, following treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janis Daly, PhD MS | VA Medical Center-Cleveland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Cleveland | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19165689 | Result | McCabe JP, Dohring ME, Marsolais EB, Rogers J, Burdsall R, Roenigk K, Pundik S, Daly JJ. Feasibility of combining gait robot and multichannel functional electrical stimulation with intramuscular electrodes. J Rehabil Res Dev. 2008;45(7):997-1006. doi: 10.1682/jrrd.2007.08.0124. | |
| 18586610 | Result | Dohring ME, Daly JJ. Automatic synchronization of functional electrical stimulation and robotic assisted treadmill training. IEEE Trans Neural Syst Rehabil Eng. 2008 Jun;16(3):310-3. doi: 10.1109/TNSRE.2008.920081. |
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Subjects were recruited through use of advertisement and by word of mouth to enter this feasibility study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gait Training After Stroke | Subjects with chronic stroke (.5-1.5 years post stroke) received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and gait robot. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This was a feasibility study of six subjects. Sample size was constrained by funding limit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Gait Training After Stroke | Subjects with chronic stroke (.5-1.5 years post stroke) received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and gait robot. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. | Observational Gait components during stance and swing phase, for pelvis, hip, knee, and ankle for each of the six participants was observed during the following conditions: Gait Robot-alone, FES-alone, and combined Gait Robot and FES. | The sample size for this feasibility study was n=6, constrained by funding limit. | Posted | Number | participants | visit 48, following treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gait Training After Stroke | subjects with Chronic stroke (.5-1.5 years post stroke)received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and Gait Robot. |
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This was a feasibility study to determine the possibility of combining two technologies. Further study of the combined treatment is needed to determine whether the feasible combined treatment is more effective than other methods.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janis Daly, Ph.D., M.S.; Director, Brain Rehabilitation Research Center of Excellence | Malcom Randall VA Medical Center, Gainesville Florida | (352) 376-1611 | 5223 | janis.daly@neurology.ufl.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Functional Neuromuscular stimulation with intramuscular electrodes |
| Device |
gait training with use of functional electrical stimulation |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The 6 study subjects with chronic stroke ambulated with FES, and observational gait analysis was performed. |
| OG002 | Combined Gait Robot and FES | The 6 study subjects with chronic stroke ambulated with combination Gait Robot and FES, and observational gait analysis was performed. |
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| 0 |
| 6 |
| 0 |
| 6 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |