Not provided
Not provided
Not provided
Not provided
unable to hire qualified personnel to run the study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gait plus cognitive training | Active Comparator | Rehabilitation of walking/gait, combined with rehabilitation of cognitive function |
|
| Gait plus arm training | Active Comparator | Rehabilitation of walking/gait, combined with rehabilitation of arm function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gait training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | pre-training (0 weeks), post training (about 12 weeks) |
Not provided
Not provided
Inclusion Criteria:
Stroke Survivor inclusion/exclusion criteria Inclusion Criteria
Able-bodied Inclusion criteria
Exclusion Criteria:
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janis J. Daly, PhD MS | North Florida/South Georgia Veterans Health System, Gainesville, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville | Florida | 32608 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were screened out if presenting with unstable medical conditions that could affect safety.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Gait and Cognitive Training | Gait rehabilitation combined with cognitive rehabilitation |
| FG001 | Gait and Arm Training | Gait rehabilitation combined with arm (reach/grasp) rehabilitation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gait and Cognitive Training | Gait rehabilitation combined with cognitive rehabilitation |
| BG001 | Gait and Arm Training | Gait rehabilitation combined with arm (reach/grasp) rehabilitation |
| 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 | 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). | Adults with chronic post-stroke hemiparesis and gait deficits | Posted | Mean | Standard Deviation | units on a scale | pre-training (0 weeks), post training (about 12 weeks) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gait and Cognitive Training | Gait rehabilitation combined with cognitive rehabilitation |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Early closure leading to small numbers of subjects analyzed. early enrollment closure due to inability for the institution to hire skilled clinicians in a timely manner in order to enroll and treat participants in the available time frame.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janis J Daly, Ph.D., Director Brain Rehabilitation Research Center | North Florida/South Georgia Gainesville VA Medical Center | 352-548-6000 | 6603 | Janis.Daly@va.gov |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| cognitive training | Behavioral | 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. |
|
| Arm training | Behavioral | Treatment will include coordination exercises for reaching and grasping. Activities will include movement of shoulder, elbow, wrist and fingers. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | Gait and Arm Training | Gait rehabilitation combined with arm (reach/grasp) rehabilitation | 0 | 7 | 0 | 7 | 0 | 7 |
Not provided
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |