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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03780296
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
University of Michigan-Flint
Information provided by (Responsible Party):
Mary Roberts, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Chronic Stroke Hemiplegia Hemiparesis Paralysis Device: Real-time action observation with augmented Kinect Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group pre-test/post-test design
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Implementing Technology Enhanced Real Time Action Observation Therapy in Persons With Chronic Stroke
Actual Study Start Date : September 5, 2017
Actual Primary Completion Date : September 26, 2018
Actual Study Completion Date : September 26, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Motor Activity Log (MAL) [ Time Frame: 5 months ]
    MAL measures participants overall use or increased use and quality of use of affected upper limb

  2. Change in 9 Hole Peg Test (9HPT) [ Time Frame: 5 months ]
    9 HPT is a timed standardized measure participants overall function of dexterity.

  3. Change in 10 Meter Walk Test (10mWT) [ Time Frame: 5 months ]
    The 10mWT is a standardized measure used to assess participants timed walking speed in meters per second over a short distance

  4. Change in Functional Reach Test (FRT) [ Time Frame: 5 months ]
    The functional reach test is a standardized measure assessing the participants ability to reach forward with unaffected arm

  5. Change in Timed Up and Go (TUG) [ Time Frame: 5 months ]
    The TUG is a standardized measure which assesses participants mobility, balance, walking ability, and fall risk in older adults

  6. Change in 5 Time Sit to Stand (5xSS) [ Time Frame: 5 months ]
    This is a standardized measure assessing participants functional lower limb strength.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780296


Locations
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United States, Michigan
MedRehab Canton
Canton, Michigan, United States, 48187
Sponsors and Collaborators
University of Michigan
University of Michigan-Flint
Investigators
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Study Chair: Hendrika L Lietz, PT, DPT, NCS Michigan Medicine

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Responsible Party: Mary Roberts, Physical Therapist, University of Michigan
ClinicalTrials.gov Identifier: NCT03780296     History of Changes
Other Study ID Numbers: HUM00121813
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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

Share upon request.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mary Roberts, University of Michigan:
Kinect
Rehabilitation
Virtual reality
Mirror therapy
Additional relevant MeSH terms:
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Stroke
Paralysis
Hemiplegia
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms