CO-OPerative Training for Stroke Rehabilitation

NCT02755805 | Completed Results DMC

• 2 other identifiers: PRO09010473K12HD055931
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive impairments occur frequently after stroke, and are associated with significant long-term activities of daily living (ADL) disability and poor quality of life. This research study will undertake an innovative approach addressing cognitive impairments, by examining a new patient-centered functionally-relevant rehabilitation intervention that teaches individuals with cognitive impairments to manage their deficits to reduce ADL disability.

Conditions

CO-OP; Attention Control

Keywords

Stroke; Rehabilitation; Cognition; Intervention; Strategy training

Outcome Measures

Primary Outcomes (1)

• Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time

  Difference between groups in mean scores (computed from Functional Independence Measure total scores) over time were examined with mixed effects models. The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated at baseline, rehabilitation discharge, month 3, and month 6 for each participant, and mean total scores were calculated fro each group at each time point.

  Baseline, rehabilitation discharge, month 3, month 6

Secondary Outcomes (3)

• Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale)

  Baseline, 3 months, 6 months

• Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale)

  Baseline, 3 months, 6 months

• Differences in Apathy Symptoms Between Groups Over Time

  Baseline, 3 months, 6 months

Study Arms (2)

CO-OP

EXPERIMENTAL

Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.

Behavioral: CO-OP

Attention Control

PLACEBO COMPARATOR

The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.

Behavioral: Attention Control

Interventions

CO-OP BEHAVIORAL

Also known as: Strategy Training

CO-OP

Attention Control BEHAVIORAL

Also known as: Reflective Listening

Attention Control

Eligibility Criteria

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

You may qualify if:

• primary diagnosis of acute stroke
• admission to acute inpatient rehabilitation
• impairment in cognitive functions (Quick Executive Interview ≥ 3)

You may not qualify if:

• dementia diagnosis (as indicated in the medical record)
• severe aphasia as indicated by score ≥ 2 on the Boston Diagnostic Aphasia Examination (3rd Edition) Severity Rating Scale (BDAE-3)
• current major depressive disorder (unless treated and in partial remission), bipolar or any other psychotic disorder (Primary Care Evaluation of Mental Disorders)
• drug or alcohol abuse within 3 months (Mini-International Neuropsychiatric Interview)
• anticipated length of stay less than 5 days

Sponsors & Collaborators

• University of Pittsburgh: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

• Kringle EA, Terhorst L, Butters MA, Skidmore ER. Clinical Predictors of Engagement in Inpatient Rehabilitation Among Stroke Survivors With Cognitive Deficits: An Exploratory Study. J Int Neuropsychol Soc. 2018 Jul;24(6):572-583. doi: 10.1017/S1355617718000085. Epub 2018 Mar 19.

  PMID: 29552996 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Elizabeth R. Skidmore, PhD, OTR/L, FAOTA
• Organization: University of Pittsburgh

skidmore@pitt.edu

(412) 383-6617

Study Officials

• Elizabeth R Skidmore, PhD, OTR/L

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair and Associate Professor

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 29, 2016
• Study Start: July 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 6, 2017
• Results First Posted: October 20, 2016

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)