A Cognitive-Augmented Mobility Program

NCT03683160 | Completed

• 1 other identifier: 446-2016
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke

Keywords

Stroke, mobility, cognitive strategy training

Outcome Measures

Primary Outcomes (1)

• Mean Canadian Occupational Performance Measure scores

  The Canadian Occupational Performance Measure (COPM) is a self-report measure of performance and satisfaction with self-selected goals. Participants are asked to generate 5 personally meaningful rehabilitation goals and rate their current performance and satisfaction on a scale from 1 to 10. Total scores are the average performance and satisfaction score. Higher scores indicate better outcomes.

  1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention

Secondary Outcomes (7)

• Mean 5 metre walk test scores

  1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention

• Mean 6-minute walk test scores

  1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention

• Mean Berg Balance Scale scores

  1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention

• Mean Activity-specific Balance Confidence Scale scores

  1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention

• Mean Community Balance and Mobility Scale scores

  1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention

Other Outcomes (5)

• Acceptability - Participant satisfaction and intent to use

  1 week post-intervention

• Feasibility - Number of participants recruited

  Through study completion, up to 9 months

• Feasibility - Number of participants who attend the intervention session

  Through study completion, up to 9 months

Study Arms (1)

Cognitive Augmented Mobility Program

EXPERIMENTAL

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).

Other: Cognitive Augmented Mobility Program

Interventions

Cognitive Augmented Mobility Program 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).

Cognitive Augmented Mobility Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre, St. John's Rehab

Toronto, Ontario, M2M 2G1, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sara McEwen, PhD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm design with two blocks.

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 25, 2018
• Study Start: March 1, 2017
• Primary Completion: January 4, 2018
• Study Completion: January 31, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Locations

CA (1)