Implementing a CO-OP Group in the Day Rehab Setting: A Pilot Study.

Status Completed

Clinical Trial Summary

This is pilot study will examine the effectiveness of a group curriculum developed from the CO-OP approach. This study has two aims, the first is to standardize the group curriculum and the second is to compare the data from the group receiving CO-OP group curriculum to the control group. Primary methods will include a standardized observation of occupational performance, an semi-structured interview measuring performance and satisfaction of occupational performance, a survey of community participation, and a focus group.

Clinical Trial Description

Many people affected by acquired brain injury do not return to participating in their environment. Cognition is a primary predictor of participation after stroke (Wong, Baum, Chen, Young, Heinemann, 2016). Metacognitive strategy training (MST) techniques are effective tools for increasing the independence of occupational therapy patients. The Cognitive Orientation to daily Occupational Performance (CO-OP) (Polatajko & Mandich, 2004) approach is an effective form of MST. The goal of CO-OP is to generalize and transfer skills and problem solving strategies learned in therapy to increase participants' participation in their environment. While CO-OP has proven effective in adults with executive function deficits in a one on one structure and in pediatrics in a group structure, adult day rehabilitation occupational therapists have found this intervention difficult to implement secondary to the current one on one structure favored for adults. As there is a dearth of literature on group CO-OP approaches for adults this is a novel study that provides a significant opportunity to improve outcomes for OT patients. The primary purpose of this study has two aims. The first is to standardize the CO-OP group curriculum first created for Zera's (2018) feasibility study. The second aim is to examine initial data comparing an adult CO-OP group with a control group. This randomized control pilot study will estimate for 22 participants, 11 for the CO-OP group and 11 for the control group, expecting 8 for each to complete the study. Quantitative data will be collected through the Canadian Occupational Performance Measure (COPM) (Law et al., 2014) an objective measure of performance and satisfaction of participants' goals, The Assessment of Motor and Process Skills (AMPS) (Fischer, & Bray Jones 2012) an observational assessment of motor and process skills, and the Community Participation Index (CPI) (Heinemann et al., 2011) a survey that measures community participation. To collect qualitative data a focus group will be completed and field notes collected. Groups will also be video recorded to collect additional qualitative data on participant group process and group facilitator use of the CO-OP cueing hierarchy. Videos will be analyzed for themes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04246385
Study type	Interventional
Source	Shirley Ryan AbilityLab
Contact
Status	Completed
Phase	N/A
Start date	January 3, 2020
Completion date	November 30, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05104645` - Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Units. Validation in Healthy Volunteers and Stroke Patients	N/A
Recruiting	`NCT05401799` - BURT Efficacy in Improving Upper Extremity Strength and Function During Post-stroke Inpatient Rehabilitation	N/A
Recruiting	`NCT04908241` - Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT)	N/A
Not yet recruiting	`NCT02431390` - Upper Limb Biofeedback Rehabilitation System (RAPAELⓇ Smart Glove Digital Treatment System) Training for Stroke Recovery	N/A
Not yet recruiting	`NCT06191549` - Brain Stimulation Enhance Post-stroke Walking Survivors and Healthy Adults	N/A
Terminated	`NCT05650606` - Inpatient Rehabilitation and Post-Discharge Outcomes With High Intensity Gait Training (HIGT) of Patients With Stroke	N/A
Active, not recruiting	`NCT05180812` - Safety and Feasibility of ExoNET	N/A
Completed	`NCT01807637` - Transcranial Direct Current Stimulation for Improving Gait Training in Stroke	N/A
Completed	`NCT03067818` - Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis	N/A
Enrolling by invitation	`NCT03986320` - Evaluation of the Effectiveness and Safety of Keeogo™ Dermoskeleton in Subjects With Mobility Impairments Due to Stroke	N/A
Recruiting	`NCT03318432` - Stroke Recovery Initiative - Registry for Stroke Research Studies
Recruiting	`NCT03934073` - Evaluation of the Benefit of the Training of the Manual Dexterity Post Stroke.	N/A
Completed	`NCT01947413` - New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke.	N/A
Recruiting	`NCT03350087` - Efficacy of rTMS and VCT on Upper Limb Function in Patients With Stroke	N/A
Active, not recruiting	`NCT02996721` - A Trial Evaluating Vitamin D Normalization on Major Adverse Cardiovascular-Related Events Among Myocardial Infarction Patients	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.