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Combined Cognitive and Gait Training (CogGait)

Primary Purpose

Stroke

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gait training

cognitive training

Arm training

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, walking, cognition, rehabilitation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.)

Exclusion Criteria:

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.)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Gait plus cognitive training

Gait plus arm training

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT02362282

First Posted

January 29, 2015

Last Updated

September 18, 2018

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT02362282

Brief Title

Combined Cognitive and Gait Training

Acronym

CogGait

Official Title

Combined Cognitive and Gait Training

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Terminated

Why Stopped

unable to hire qualified personnel to run the study

Study Start Date

December 2013 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

stroke, walking, cognition, rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gait plus cognitive training

Arm Type

Active Comparator

Arm Description

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

Arm Title

Gait plus arm training

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Gait training

Intervention Description

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

Intervention Name(s)

cognitive training

Intervention Description

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

Intervention Name(s)

Arm training

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in the Gait Assessment and Intervention (G.A.I.T.) Score

Description

Time Frame

pre-training (0 weeks), post training (about 12 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.) Exclusion Criteria: 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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janis J. Daly, PhD MS

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Combined Cognitive and Gait Training

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