Usability Testing of Affordable Haptic Robots for Stroke Therapy

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02772809

Acronym

Theradrive

Enrollment

Registered

2016-05-16

Start date

2014-03-31

Completion date

2017-07-31

Last updated

2020-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegia, Stroke

Keywords

stroke, hemiplegia, rehabilitation, robotics, neuroplasticity

Brief summary

Stroke survivors with hemiplegia will be evaluated by rehabilitation professionals and asked to perform a battery of assessments to test the viability and usability of a force-feedback robot that adapts to each individual subject's performance. Subsequently, they will be asked to complete post-assessment questionnaires that provide feedback to the researchers on their observations and thoughts about the therapy devices.

Detailed description

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. Preliminary results from various studies have shown that the original TheraDrive system lacked a robust mechanical linkage which could withstand the forces exerted by patients, lacked a patient-specific adaptive controller to deliver personalized therapy, and was not capable of delivering effective therapy to severely low-functioning patients. A new low-cost, high-force haptic robot with a single degree of freedom has been developed to address these concerns. This study has two purposes: first, to test the viability and usability of the new robot system alongside the original TheraDrive system; and second, to test if low-functioning patients benefit, and if so how much, from using force-feedback therapy as opposed to devices with zero impedance. This will be done by recruiting approximately 36 human subjects. Exercises will be performed by study subjects and an adaptive controller will monitor patient performance to ensure that exercises are difficult but doable, which is important for maintaining patient motivation. It is hypothesized that not only will the new system be viable, but that it will provide better robot-assisted therapy to a large variety of patients, especially low-functioning stroke survivors with hemiplegia.

Interventions

DEVICEHaptic 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Stroke survivors at least 18 years of age with hemiplegia. * The subject's stroke must have occurred at least 3 months prior to enrollment in the study. * Low and Moderate functioning stroke survivors as measured by Fugl- Meyer * Not depressed * No more than Mild Cognitive Deficit * Participants must be able to sit upright for 4 hours at a time in Part A of the study; and 2 hours at a time, 3 days a week, for Part B of the study. * The subject's stroke must have occurred at least 3 months prior to enrollment in the study.

Exclusion criteria

* Greater than mild cognitive deficits * Greater than mild depression. A member of the research team will administer Beck's Depression Inventory (BDI) to each study participant over the phone. If the participant is found to have greater than mild depression, as measured by the BDI, they will not qualify for the study. * Receiving rehabilitation on the upper limb. * Received Botox injections within the past 3 months. * Suffering from contractures (chronic loss of joint motion) or debilitating spasticity in the upper extremity. * Experiencing greater than mild pain, and/or the PI determines that the participant should no longer continue working with the novel therapy devices, the study will be stopped.

Design outcomes

Primary

Measure	Time frame	Description
Fugl Meyer	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	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	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.

Secondary

Measure	Time frame	Description
Grip Strength	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)	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	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

Countries

United States

Participant flow

Recruitment details

Stroke survivors over the age of 18 with hemiplegia, who are three months post event, and have varying levels of impairment in the upper extremities will be recruited. All use of the TheraDrive system will take place at the Rehabilitation Robotics Lab on the ﬁrst ﬂoor of Penn Rittenhouse

Participants by arm

Arm	Count
Subjects With Varying Levels of Motor Impairment Subjects with varying levels of motor impairments who are ages 18 and older.	23
Total	23

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	not completed some tasks	6

Baseline characteristics

Characteristic	Subjects With Varying Levels of Motor Impairment	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	23 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	9 Participants	—
Sex: Female, Male Male	8 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 17
other Total, other adverse events	0 / 17
serious Total, serious adverse events	0 / 17

Outcome results

Primary

Box and Blocks

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

Time frame: At Session 0. Pre-intervention