NCT02852369

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable stroke

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
Last Updated

August 2, 2016

Status Verified

July 1, 2016

Enrollment Period

9 months

First QC Date

July 27, 2016

Last Update Submit

August 1, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Movement of the hemiparetic upper extremity as measured by accelerometry

    24 hour recordings over 8 day periods

Study Arms (1)

Task Oriented Training

EXPERIMENTAL

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

Interventions

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.

Task Oriented Training

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • months after their stroke which would classify them in the subacute level of recovery
  • all formal occupational therapy was completed.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Marsha Neville, PhD, OT

    Texas Woman's University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Student

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 2, 2016

Study Start

June 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 2, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share