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

NCT03780296 | Completed FDA Device

• 1 other identifier: HUM00121813
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke; Hemiplegia; Hemiparesis; Paralysis

Keywords

Kinect; Rehabilitation; Virtual reality; Mirror therapy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Real-Time Action Observation with augmented Kinect

EXPERIMENTAL

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

Interventions

Real-time action observation with augmented Kinect DEVICE

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.

Real-Time Action Observation with augmented Kinect

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University of Michigan: lead
• University of Michigan-Flint: collaborator

Study Sites (1)

MedRehab Canton

Canton, Michigan, 48187, United States

Location

MeSH Terms

Conditions

Hemiplegia; Paresis; Paralysis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hendrika L Lietz, PT, DPT, NCS

  Michigan Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Model Details: Single group pre-test/post-test design

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: September 5, 2017
• Primary Completion: September 26, 2018
• Study Completion: September 26, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)