Usability Testing of Affordable Haptic Robots for Stroke Therapy (Theradrive)
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|ClinicalTrials.gov Identifier: NCT02772809|
Recruitment Status : Terminated (The robot was no longer available to the study.)
First Posted : May 16, 2016
Results First Posted : September 4, 2020
Last Update Posted : September 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke Hemiplegia||Device: Haptic Robot Therapy with Games||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Usability Testing of Affordable Haptic Robots for Stroke Therapy|
|Actual Study Start Date :||March 2014|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
Stroke survivors with low and moderate motor deficits
Subjects with low and moderate motor deficits will 1) complete exercises with 2 commercial (joystick and wheel) and the Theradrive haptic robot after pre assessment 2) then experience 12 therapy sessions on the Theradrive haptic robot with Adaptive Feedback. 3) Assessments pre and post therapy.
Device: Haptic Robot Therapy with Games
Commercial Joystick and Wheels Plus the Haptic TheraDrive Robot will be used. Haptic Theradrive is a low-cost robotic system for post-stroke upper extremity rehabilitation. The system uses off-the-shelf computer gaming wheels with force feedback to help reduce motor impairment and improve function in the arms of stroke survivors.
- Fugl Meyer [ Time Frame: At 0 weeks ]The primary outcomes are motor control for the upper limb: Subjects completed tasks on scale; Motor scale maximum is 66. minimum is 0. Lower is more impaired. Higher is less impaired.
- Box and Blocks [ Time Frame: At Session 0. Pre-intervention ]Measures ADL Function. Completed reach and grasp activities. Reached for 1 inch cube and placed with impaired arm. More blocks indicate higher function. Less blocks lower function
- Tracking Accuracy [ Time Frame: At Session 0 ]Tracking accuracy is measured using the normalized root mean square, which is a measure for error in tracking performance with respect to a desired goal. Root mean squared divided by the maximum error if person does not move. The higher the decimal the higher the error made. Lower is better performance.
- Grip Strength [ Time Frame: pre-intervention ]Grip strength as measured by a dynamometer. Subjects were asked to squeeze a dynamometer with impaired arm. Higher forces mean better function
- Montreal Cognitive Assessment (MOCA) [ Time Frame: pre-intervention ]A brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for impairment in cognition domains. Maximum is 30. Minimum is 0; Low is <17 is severe cognitive impairment; a score 26 and higher is normal cognition.
- Becks Depression Scale [ Time Frame: Pre-intervention ]Measures depression. The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression (Beck, et al., 1961). Maximum is 63 Total Score_______________Levels of Depression 1-10____________________These ups and downs are considered normal 11-16___________________ Mild mood disturbance 17-20___________________Borderline clinical depression 21-30___________________Moderate depression 31-40___________________Severe depression over 40__________________Extreme depression
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): NCT02772809
|United States, Pennsylvania|
|Penn Medicine Rittenhouse|
|Philadelphia, Pennsylvania, United States, 19146|
|Principal Investigator:||Michelle J Johnson, PhD||PENN MEDICINE RITTENHOUSE|