Task Oriented Training and Evaluation at Home (TOTE Home)

Objective: To determine the effectiveness of an upper extremity, task oriented training program delivered at home (TOTE Home) for people who are in the subacute recovery phase of a stroke.

Method: A single-subject AB series design with a follow-up to assess the effectiveness of TOTE Home which includes a maximum of 30, one hour sessions of training conducted in participants' homes. Repeated target measures of accelerometry and level of confidence to be analyzed throughout the study. Change scores from standardized assessments to be evaluated at baseline, post-intervention, and follow-up time periods.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Task Oriented Treatment

Detailed Description

Hemiparesis following a stroke frequently leads to "learned non-use" of the weaker arm and hand. Task oriented training has been suggested as a contemporary neurorehabilitation technique. A single-subject AB series design with a follow-up was conducted to assess the effectiveness of a task oriented training program administered in participants' homes. This intervention, Task Oriented Training at Home (TOTE Home), incorporated current experience-dependent plasticity aspects modeled after the Acquired Skill Acquisition Program (ASAP) protocol parameters and principles of task oriented training as suggested by Lang and Birkenmeier in 2014. Repeated measures of accelerometry and level of confidence on a priority task were analyzed with visual analysis of changes in level, trend, and slope. Change scores from standardized assessments for the upper extremity, Motor Activity Log, Stroke Impact Scale question of recovery, Functional Test for the Hemiparetic Upper Extremity, and Canadian Occupational Performance Measure were evaluated on data collected at baseline, post-intervention, and follow-up time periods.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• upper extremity hemiparesis due to a stroke but met minimal movement criteria in the affected arm and hand (at least 10 degrees of active movement at the wrist, elbow, and shoulder movement, along with 10 degrees of active movement in the thumb and two other fingers)
• minimal cognitive deficits as demonstrated by a 24 or higher on the Mini-Mental Status Exam
• able to identify at least five specific tasks participants wish to achieve with their affected upper extremity. This was assessed with the Canadian Occupational Performance Measure (COPM)
• at least 21 years of age
• able to communicate in English
• 3-12 months after their stroke which would classify them in the subacute level of recovery
• all formal occupational therapy was completed.

Exclusion Criteria:

• upper extremity pain that interfered with activities of daily living
• requiring maximal assistance for mobility
• arm or hand injury (unrelated to the stroke)
• upper extremity amputations
• inability to participate due to any illness, social or geographical reason, and any other diagnosis or limiting conditions that would affect participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Task Oriented Training; The intervention administered during each of the training sessions was modeled after the protocol outlined in Winstein et al. (2013) however implementation was in the participant's home setting and involved tasks in the participant's real world. The manual entitled, "Upper-Extremity Task-Specific Training After Stroke or Disability" by Lang and Birkenmeier (2014) was also utilized to give a general overview of task specific training for the upper extremity and to help guide each activity the participant chose to work on.

Behavioral: Task Oriented Treatment; The intervention administered during each of the training sessions was modeled after the protocol outlined in Winstein et al. (2013) however implementation was in the participant's home setting and involved tasks in the participant's real world. The manual entitled, "Upper-Extremity Task-Specific Training After Stroke or Disability" by Lang and Birkenmeier (2014) was also utilized to give a general overview of task specific training for the upper extremity and to help guide each activity the participant chose to work on.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Movement of the hemiparetic upper extremity as measured by accelerometry	24 hour recordings over 8 day periods

Collaborators and Investigators

• Sponsor: Rowe, Veronica, M.D.
• Investigators: Study Chair: Marsha Neville, PhD, OT, Texas Woman's University

Publications and helpful links

General Publications

• Rowe VT, Neville M. Task Oriented Training and Evaluation at Home. OTJR (Thorofare N J). 2018 Jan;38(1):46-55. doi: 10.1177/1539449217727120. Epub 2017 Aug 31.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Estimate): August 2, 2016
• Last Update Submitted That Met QC Criteria: August 1, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: TOTE Home 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO