Stroke
Conditions
Keywords
stroke, walking, cognition, rehabilitation
Brief summary
Recent research in gait training for stroke survivors showed that coordinated gait components can be best restored using the following interventions together: coordination exercises, over ground gait training, and body weight supported treadmill training (BWSTT). These results are important because, to the investigators' knowledge, there have been no other reports of the restoration of coordinated gait components for those with persistent gait deficits (\> 6 months after stroke). However, a remaining problem was that the restored coordinated gait movements measured in the laboratory did not generalize for many subjects to the everyday environment. The confluence of several factors can cause lack of generalization. First, dual task performance (gait and cognitive attention task) can degrade both gait and attention ability, even in healthy adults. Second, stroke can impair attention. Third, during walking in the everyday environment, attention is required in order to safely process normally occurring stimuli. Therefore, given the success of the new gait training protocol in the lab setting, it is important to address the problems remaining for generalization of the recovered coordinated gait pattern to the everyday environment. The primary hypothesis of this study is that greater gains in gait speed will be produced by combined motor and cognitive training versus motor training alone.
Detailed description
Aim 1, Hypothesis Ia: Comparison of combined motor and cognitive training vs motor training alone. For Aim 1, Hypothesis Ia, this will be a randomized, controlled study. For the two groups, 38 subjects will be enrolled and randomized to either: A) Motor + Cognitive Training; or B) Motor Training alone. Subjects will first be stratified according to coordination and gait deficit severity, as described below. After stratification, the subject will be randomized to one of the two intervention groups for Hypothesis Ia. All the subjects will receive treatment 5 times/week, 3hrs/session, for 12 weeks or for a total of 60 treatment sessions. Group A will receive combined motor and cognitive training; Table 2 (below) shows the graduated approach to providing combined gait and cognitive training. Data collection will be at weeks 1, 6, 12, and 24 (i.e., before, mid-treatment and after treatment, and then 3 months after the end of the treatment protocol. Comparison will be made between the two groups to determine whether there was any additive effectiveness of the cognitive training. Aim 2, Hypotheses IIa-d: Pre/post-treatment comparisons within Group A, receiving combined motor and cognitive training. For Aim 2, Hypotheses IIa-d, this will be a single cohort pre/post-treatment comparison within Group A receiving combined motor and cognitive training. Aim 3, Hypotheses IIIa-d: Pre/post-treatment comparisons within Group B, receiving motor training alone. For Aim 3, Hypotheses IIIa-d, this will be a single cohort pre/post-treatment comparison within Group B, receiving motor training alone.
Interventions
BEHAVIORALGait training
Treatment will include coordination exercises and over ground gait training for impaired muscle groups and related gait deficits. The therapy will be provided by a clinical physical therapist specializing in rehabilitation for stroke patients, according to established, conventional guidelines. The protocol was used in the investigators' prior studies, and is designed to restore voluntary control of ankle dorsiflexion during swing phase; hip flexion during swing phase, knee flexion at toe-off, knee flexion during swing phase; knee extension before heel strike; knee control during stance phase; pelvic control during stance phase; and whole body balance control during weight shifting. Newly-learned coordinated movements will be integrated into practice of coordinated gait components. Cognitive rehabilitation will begin with the least difficult aspects of attention control, and progress to the more difficult. Home practice and generalization exercises will be assigned.
BEHAVIORALcognitive training
Cognitive training is designed to enhance attention, intention, executive function, decision making and reaction time. Commercially available computer software will be used, as well as custom cognitive training.
BEHAVIORALArm training
Treatment will include coordination exercises for reaching and grasping. Activities will include movement of shoulder, elbow, wrist and fingers.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Stroke Survivor inclusion/
Exclusion criteria
Inclusion Criteria * Cognition sufficiently intact to give valid informed consent to participate. \* * Sufficient endurance to participate in rehabilitation sessions. * Ability to follow 2 stage commands. * Medically Stable * Age \> 21 years. * Impaired ambulation as follows: inability to flex the knee and ankle in the sagittal plane, in a normal manner so the foot clears the floor; inability to control normal knee angle during single limb weight bearing during stance phase. * At least 6 months post stroke. Able-bodied Inclusion criteria * Criteria to be included is that they should be healthy with no history of a neurological disease or orthopedic impairment.\*\* * Not Pregnant. * No Claustrophobia (only for the sub-sample asked to undergo fMRI.) * No counterindications to MR scanning including, pregnancy, weight inappropriate for height, ferrous objects within the body (only for the sub-sample asked to undergo fMRI.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Gait Assessment and Intervention (G.A.I.T.) Score | pre-training (0 weeks), post training (about 12 weeks) | Coordination of walking, scored using the investigators' novel G.A.I.T. measure. This measure evaluated limb and joint movements while participants walk overground at preferred speed. Range of scale: 0 (normal) to 64 (extremely discoordinated gait). |
Countries
United States
Participant flow
Pre-assignment details
Participants were screened out if presenting with unstable medical conditions that could affect safety.
Participants by arm
| Arm | Count |
|---|---|
| Gait and Cognitive Training Gait rehabilitation combined with cognitive rehabilitation | 5 |
| Gait and Arm Training Gait rehabilitation combined with arm (reach/grasp) rehabilitation | 7 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Gait and Cognitive Training | Gait and Arm Training | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 5 Participants | 8 Participants |
| Region of Enrollment United States | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 7 |
| other Total, other adverse events | 1 / 4 | 0 / 7 |
| serious Total, serious adverse events | 0 / 4 | 0 / 7 |
Outcome results
Primary
Change in the Gait Assessment and Intervention (G.A.I.T.) Score
Coordination of walking, scored using the investigators' novel G.A.I.T. measure. This measure evaluated limb and joint movements while participants walk overground at preferred speed. Range of scale: 0 (normal) to 64 (extremely discoordinated gait).
Time frame: pre-training (0 weeks), post training (about 12 weeks)
Population: Adults with chronic post-stroke hemiparesis and gait deficits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gait and Cognitive Training | Change in the Gait Assessment and Intervention (G.A.I.T.) Score | pre treatment mean | 28.8 units on a scale | Standard Deviation 6.9 |
| Gait and Cognitive Training | Change in the Gait Assessment and Intervention (G.A.I.T.) Score | post treatment mean | 29.9 units on a scale | Standard Deviation 5.9 |
| Gait and Arm Training | Change in the Gait Assessment and Intervention (G.A.I.T.) Score | pre treatment mean | 29.5 units on a scale | Standard Deviation 3.8 |
| Gait and Arm Training | Change in the Gait Assessment and Intervention (G.A.I.T.) Score | post treatment mean | 28.7 units on a scale | Standard Deviation 7.7 |
p-value: 0.54t-test, 2 sided