Stroke
Conditions
Keywords
cerebrovascular accident, electrical stimulation, gait training, motor learning
Brief summary
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).
Interventions
DEVICEGait Robot
gait training with the use of a gait robot
DEVICEFunctional Neuromuscular stimulation with intramuscular electrodes
gait training with use of functional electrical stimulation
Sponsors
US Department of Veterans Affairs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than or equal to 6 months after stroke * 21 years or older * Ability to follow 2 step commands * Inability to move leg normally
Exclusion criteria
* Pacemaker * Progressive medical condition (i.e. Parkinsons Disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. | visit 48, following treatment | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited through use of advertisement and by word of mouth to enter this feasibility study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Gait Training After Stroke |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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.
Time frame: visit 48, following treatment
Population: The sample size for this feasibility study was n=6, constrained by funding limit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gait Robot-alone Training | Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. | allowed for knee control-stance phase | 6 participants |
| Gait Robot-alone Training | Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. | allowed for lateral weight shift | 0 participants |
| Gait Robot-alone Training | Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. | allowed for ankle movement in sagittal plane | 6 participants |
| FES-Alone | Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. | allowed for knee control-stance phase | 6 participants |
| FES-Alone | Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. | allowed for lateral weight shift | 6 participants |
| FES-Alone | Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. | allowed for ankle movement in sagittal plane | 6 participants |
| Combined Gait Robot and FES | Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. | allowed for lateral weight shift | 6 participants |
| Combined Gait Robot and FES | Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. | allowed for ankle movement in sagittal plane | 6 participants |
| Combined Gait Robot and FES | Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. | allowed for knee control-stance phase | 6 participants |