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

Primary Purpose

Chronic Stroke, Hemiplegia, Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Real-time action observation with augmented Kinect
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Chronic Stroke focused on measuring Kinect, Rehabilitation, Virtual reality, Mirror therapy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MedRehab Canton

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Real-Time Action Observation with augmented Kinect

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Motor Activity Log (MAL)
MAL measures participants overall use or increased use and quality of use of affected upper limb
Change in 9 Hole Peg Test (9HPT)
9 HPT is a timed standardized measure participants overall function of dexterity.
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
Change in Functional Reach Test (FRT)
The functional reach test is a standardized measure assessing the participants ability to reach forward with unaffected arm
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
Change in 5 Time Sit to Stand (5xSS)
This is a standardized measure assessing participants functional lower limb strength.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2018
Last Updated
December 17, 2018
Sponsor
University of Michigan
Collaborators
University of Michigan-Flint
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1. Study Identification

Unique Protocol Identification Number
NCT03780296
Brief Title
Implementing Technology Enhanced Real Time Action Observation Therapy in Persons With Chronic Stroke
Acronym
TERTAOT
Official Title
Implementing Technology Enhanced Real Time Action Observation Therapy in Persons With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
September 26, 2018 (Actual)
Study Completion Date
September 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
University of Michigan-Flint

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke, Hemiplegia, Hemiparesis, Paralysis
Keywords
Kinect, Rehabilitation, Virtual reality, Mirror therapy

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group pre-test/post-test design
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrika L Lietz, PT, DPT, NCS
Organizational Affiliation
Michigan Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
MedRehab Canton
City
Canton
State/Province
Michigan
ZIP/Postal Code
48187
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Dissemination at local, state and national conferences via platform and poster presentations. Share upon request.

Learn more about this trial

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

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