Theradrive: Usability Testing of Affordable Haptic Robots for Stroke Therapy

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02772809
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arm: 1
• Actual Duration (Months): 40
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Hemiplegia	Device: Haptic Robot Therapy with Games	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Usability Testing of Affordable Haptic Robots for Stroke Therapy
• Actual Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

3. 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 Outcome Measures

1. 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

2. 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.

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn Medicine Rittenhouse	Philadelphia	Pennsylvania	United States	19146

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Michelle J Johnson, PhD, PENN MEDICINE RITTENHOUSE

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 14, 2020

More Information

Additional Information:

• Affordable stroke therapy in high-, low- and middle-income countries: From Theradrive to Rehab CARES, a compact robot gym
• A computer model of the human arm: Predictive biomechanics for the theradrive rehabilitation system

Publications

• Johnson MJ, Ramachandran B, Paranjape RP, Kosasih JB. Feasibility study of TheraDrive: a low-cost game-based environment for the delivery of upper arm stroke therapy. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:695-8.
• Ruparel R, Johnson MJ, Strachota E, McGuire J, Tchekanov G. Evaluation of the TheraDrive system for robot/computer assisted motivating rehabilitation after stroke. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:811-4. doi: 10.1109/IEMBS.2009.5332386.
• Theriault A, Nagurka M, Johnson MJ. Design and development of an affordable haptic robot with force-feedback and compliant actuation to improve therapy for patients with severe hemiparesis. IEEE Trans Haptics. 2014 Apr-Jun;7(2):161-74. doi: 10.1109/TOH.2013.51.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02772809
• Other Study ID Numbers: 819787
• First Posted: May 16, 2016
• Last Update Posted: Sep 4, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of Pennsylvania: stroke; hemiplegia; rehabilitation; robotics; neuroplasticity
• Additional relevant MeSH terms: Stroke; Hemiplegia

Study Results

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

Arm/Group Title	Stroke Survivors With Varying Levels of Motor Impairment
Arm/Group Description	Stroke survivors with varying levels of motor deficit impairment in their upper extremity.
Period Title: Overall Study
STARTED	23
COMPLETED	17
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Subjects With Varying Levels of Motor Impairment
Arm/Group Description	Subjects with varying levels of motor impairments who are ages 18 and older.
Overall Participants	23
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	23 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	9 39.1%
Male	8 34.8%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Fugl Meyer
Description	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.
Time Frame	At 0 weeks

Outcome Measure Data

Analysis Population Description

6 subjects did not complete so not included in the analysis

Arm/Group Title	Stroke Survivors With Motor Impairment
Arm/Group Description	All subject used robot for tracking tasks
Measure Participants	17
Mean (Standard Deviation) [score on a scale]	42.5 (20.2)

2. Primary Outcome

Title	Box and Blocks
Description	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

Outcome Measure Data

Analysis Population Description

6 subjects did not complete so not included in the analysis

Arm/Group Title	Subjects With Motor Impairment
Arm/Group Description	Subjects with deficit ages 18 and older.
Measure Participants	17
Mean (Standard Deviation) [# of blocks]	19.11 (15.49)

3. Primary Outcome

Title	Tracking Accuracy
Description	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.
Time Frame	At Session 0

Outcome Measure Data

Analysis Population Description

6 subjects did not complete so not included in the analysis

Arm/Group Title	Stroke Survivors With Motor Impairments
Arm/Group Description	All subject used robot for tracking tasks
Measure Participants	17
Mean (Standard Deviation) [accuracy index]	0.73 (0.44)

4. Secondary Outcome

Title	Grip Strength
Description	Grip strength as measured by a dynamometer. Subjects were asked to squeeze a dynamometer with impaired arm. Higher forces mean better function
Time Frame	pre-intervention

Outcome Measure Data

Analysis Population Description

6 subjects did not complete so not included in the analysis

Arm/Group Title	Subjects With Motor Impairment
Arm/Group Description	Subjects completed tasks with robot and with clinical scale.
Measure Participants	17
Mean (Standard Deviation) [lbs]	26.88 (22.73)

5. Secondary Outcome

Title	Montreal Cognitive Assessment (MOCA)
Description	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.
Time Frame	pre-intervention

Outcome Measure Data

Analysis Population Description

6 subjects did not complete so not included in the analysis

Arm/Group Title	Subjects With Motor Impairments
Arm/Group Description	Subjects with motor impairments who are ages 18 and older.
Measure Participants	17
Mean (Standard Deviation) [units on a scale]	22.5 (4.6)

6. Secondary Outcome

Title	Becks Depression Scale
Description	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
Time Frame	Pre-intervention

Outcome Measure Data

Analysis Population Description

6 subjects did not complete so not included in the analysis

Arm/Group Title	Stroke Survivors With Motor Impairments
Arm/Group Description	All subject used robot for tracking tasks;
Measure Participants	17
Mean (Standard Deviation) [units on a scale]	7.25 (5.72)

Adverse Events

Time Frame	40 months
Adverse Event Reporting Description	No adverse events were reported.
Arm/Group Title	Haptic Robot Therapy With Games
Arm/Group Description	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. 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.
All Cause Mortality
	Haptic Robot Therapy With Games
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Serious Adverse Events
	Haptic Robot Therapy With Games
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Other (Not Including Serious) Adverse Events
	Haptic Robot Therapy With Games
	Affected / at Risk (%)	# Events
Total	0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.