Combined Cognitive and Gait Training

NCT ID: NCT02362282

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-06-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gait plus cognitive training

Rehabilitation of walking/gait, combined with rehabilitation of cognitive function

Group Type: ACTIVE_COMPARATOR

Gait training

Intervention Type: 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.

cognitive training

Intervention Type: 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.

Gait plus arm training

Rehabilitation of walking/gait, combined with rehabilitation of arm function

Group Type: ACTIVE_COMPARATOR

Gait training

Intervention Type: 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.

Arm training

Intervention Type: BEHAVIORAL

Treatment will include coordination exercises for reaching and grasping. Activities will include movement of shoulder, elbow, wrist and fingers.

Interventions

Gait 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.

Intervention Type: BEHAVIORAL

cognitive 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.

Intervention Type: BEHAVIORAL

Arm training

Treatment will include coordination exercises for reaching and grasping. Activities will include movement of shoulder, elbow, wrist and fingers.

Intervention Type: BEHAVIORAL

Eligibility 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.

• 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.)

Exclusion Criteria

• Acute or progressive cardiac, vascular, renal, respiratory, neurological disorders or malignancy.
• Active psychiatric diagnosis or psychological condition, or active drug/alcohol abuse.
• Lower motor neuron damage or radiculopathy.
• Orthopedic impairment. **
• More than one stroke.
• Cerebellar dysfunction.
• Fugl-Meyer lower limb motor sub-score greater than 32.
• No simultaneous gait rehabilitation participation.
• Pregnant.
• Claustrophobia (only for the sub-sample asked to undergo fMRI.)
• Criteria specific to MR scanning, including pregnancy, weight inappropriate for height, ferrous objects within the body (only for the sub-sample asked to undergo fMRI.)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janis J. Daly, PhD MS

Role: PRINCIPAL_INVESTIGATOR

North Florida/South Georgia Veterans Health System, Gainesville, FL

Locations

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, United States

Countries

United States

Other Identifiers

D7675-R

Identifier Type: -

Identifier Source: org_study_id