A Cognitive-Augmented Mobility Program

NCT ID: NCT03683160

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-01-31

Brief Summary

This project will combine best-evidence gait and mobility training with best evidence cognitive strategy training to produce a new cognitive-augmented mobility intervention that is expected to optimize long-term functional mobility outcomes for those living with stroke. More importantly, the new cognitive-augmented mobility program (CAMP) will address two crucial outcomes that do not occur with current approaches: 1. Maintenance of mobility gains after discharge from formal rehabilitation and 2. Transfer of skills learned in rehabilitation to real-world community living. This project will result in a new, fully defined intervention, and will provide effect size and cost estimates to design a future appropriately powered randomized controlled trial (RCT).

Detailed Description

Difficulty walking is a leading cause of activity restriction in survivors of stroke. It is directly related to important functional issues, such as challenges in crossing a street in time, difficulty walking to a bus stop and increased risk of falls. These functional issues can then impact a person's confidence to move around their community, ultimately leading to lower levels of physical activity and potential negative health consequences. The best way to optimize recovery in walking and mobility is not yet known, and there are critical gaps in existing treatments. While some approaches are effective in the short term, strategies to promote the maintenance of improvements are not well established, benefits are usually not transferred beyond the specific skills trained and the specific context in which they were learned, few interventions impact community participation, and cost effectiveness has rarely been investigated. A potential solution exists in combining best-evidence interventions: task-specific gait and mobility training to improve skill quality, cardiorespiratory and strength exercises to improve endurance and speed, and cognitive strategy training to teach problem solving, improve confidence and to ensure long-term maintenance and transfer of skills to home and community settings. The investigators will combine best evidence mobility interventions with best evidence cognitive strategy training to develop and evaluate a new intervention to optimize long-term functional mobility outcomes for those living with stroke. The project consists of two sequential stages: 1) intervention development through literature synthesis; face validity testing using focus groups with patients, family members and expert stroke rehabilitation clinicians; and intervention refinement; followed by 2) feasibility/pilot testing with 10 people more than 6 months post stroke. Anticipated outcomes include a fully developed intervention with the potential to optimize mobility rehabilitation and effect size estimates to permit the design of a future, appropriately-powered randomized controlled trial.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive Augmented Mobility Program

CAMP will combine education, one-on-one cognitive strategy training, and a cardiovascular and strength-training program conducted within a group setting. It will be run as a group of up to 6 participants, facilitated by a physiotherapist and a physiotherapy assistant or kinesiologist. It consists of 2 phases with a total of 19 sessions: Intervention Preparation (3 sessions), Active Intervention (16 sessions), and Follow-Up (1 session).

Group Type: EXPERIMENTAL

Cognitive Augmented Mobility Program

Intervention Type: OTHER

CAMP will combine education, one-on-one cognitive strategy training, and a cardiovascular and strength-training program conducted within a group setting. It will be run as a group of up to 6 participants, facilitated by a physiotherapist and a physiotherapy assistant or kinesiologist. It consists of 2 phases with a total of 19 sessions: Intervention Preparation (3 sessions), Active Intervention (16 sessions), and Follow-Up (1 session).

Interventions

Cognitive Augmented Mobility Program

CAMP will combine education, one-on-one cognitive strategy training, and a cardiovascular and strength-training program conducted within a group setting. It will be run as a group of up to 6 participants, facilitated by a physiotherapist and a physiotherapy assistant or kinesiologist. It consists of 2 phases with a total of 19 sessions: Intervention Preparation (3 sessions), Active Intervention (16 sessions), and Follow-Up (1 session).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients aged 18 years of age or older
• post stroke
• have completed outpatient therapy
• can walk a minimum of 3 metres with or without an aid

Exclusion Criteria

• patient does not a mobility goal
• neurological diagnoses other than stroke
• major psychiatric illness
• significant dementia (MoCA scores < 21)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara McEwen, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Research Institute

Locations

Sunnybrook Health Sciences Centre, St. John's Rehab

Toronto, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

446-2016

Identifier Type: -

Identifier Source: org_study_id