Implementing Technology Enhanced Real Time Action Observation Therapy in Persons With Chronic Stroke (TERTAOT)

This is a feasibility study to alter the Microsoft Kinect software to be used as a rehabilitation tool. The prototype used is still in the early developing stage. The purpose of this research study is to develop a prototype of altered Microsoft Kinect Software and determine its use in improving the function of the study subjects' weaker extremities. The altered software will allow a viewing of the mirror image of the involved limb as it is moved. However, the image that is viewed will reflect normal movement even if the limb cannot move normally. By viewing normal movement of the weaker limbs the "mirror neuron" network in the brain will become activated and will ultimately improve the function of the weaker side.

Study Overview

• Status: Completed
• Conditions: Paralysis; Hemiplegia; Hemiparesis; Chronic Stroke
• Intervention / Treatment: Device: Real-time action observation with augmented Kinect

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Canton, Michigan, United States, 48187
      • MedRehab Canton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• - Adults 40 years of age and older having had a stroke greater than 6-months post onset
• Able to follow commands in English
• Medically stable and without acute illness, such as infection, inflammation, ongoing chest pain, or short of breath with walking and light activities
• Able to stand up off of a standard height chair (16-18 inches)

Exclusion Criteria:

• - Cognitive impairment as measured by a score below 24/30 on Mini Mental State Examination
• A diagnoses of cancer involving the nervous or musculoskeletal system
• Severe pain in arms, legs, or spine measured by >6/10 using Verbal Numerical Pain Rating Scale that prevents them from standing or walking independently
• Diagnoses of other neurological diseases except for stroke, such as spinal cord injury or Parkinson's disease etc.
• Individuals at the advanced stage of a disease and with less than 12 months to live.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• 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: Real-Time Action Observation with augmented Kinect; Participants will receive 30 minutes of the augmented kinect software in real-time undergoing an exercise protocol involving seated upper extremity exercises, seated lower extremity exercises and standing upper extremity exercises.	Device: Real-time action observation with augmented Kinect; Participants will receive 30 minutes of the augmented kinect software in real-time undergoing an exercise protocol involving seated upper extremity exercises, seated lower extremity exercises and standing upper extremity exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Motor Activity Log (MAL)	MAL measures participants overall use or increased use and quality of use of affected upper limb	5 months
Change in 9 Hole Peg Test (9HPT)	9 HPT is a timed standardized measure participants overall function of dexterity.	5 months
Change in 10 Meter Walk Test (10mWT)	The 10mWT is a standardized measure used to assess participants timed walking speed in meters per second over a short distance	5 months
Change in Functional Reach Test (FRT)	The functional reach test is a standardized measure assessing the participants ability to reach forward with unaffected arm	5 months
Change in Timed Up and Go (TUG)	The TUG is a standardized measure which assesses participants mobility, balance, walking ability, and fall risk in older adults	5 months
Change in 5 Time Sit to Stand (5xSS)	This is a standardized measure assessing participants functional lower limb strength.	5 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: University of Michigan-Flint
• Investigators: Study Chair: Hendrika L Lietz, PT, DPT, NCS, Michigan Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Actual): September 26, 2018
• Study Completion (Actual): September 26, 2018

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 17, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Rehabilitation; Virtual reality; Mirror therapy; Kinect
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paralysis; Hemiplegia; Paresis
• Other Study ID Numbers: HUM00121813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Dissemination at local, state and national conferences via platform and poster presentations.

Share upon request.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No