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

Hemiplegia Clinical Trial

— TERTAOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780296
• Other study ID #: HUM00121813
• Status: Completed
• Phase: N/A
• Start date: September 5, 2017
• Est. completion date: September 26, 2018

Study information

• Verified date: December 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 26, 2018
• Est. primary completion date: September 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Stroke
• Hemiparesis
• Hemiplegia
• Paralysis
• Paresis
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	MedRehab Canton	Canton	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	University of Michigan-Flint

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Motor Activity Log (MAL)	MAL measures participants overall use or increased use and quality of use of affected upper limb	5 months
Primary	Change in 9 Hole Peg Test (9HPT)	9 HPT is a timed standardized measure participants overall function of dexterity.	5 months
Primary	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
Primary	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
Primary	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
Primary	Change in 5 Time Sit to Stand (5xSS)	This is a standardized measure assessing participants functional lower limb strength.	5 months