Usability Testing of Affordable Haptic Robots for Stroke Therapy

NCT02772809 | Terminated Results DMC

• 1 other identifier: 819787
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiplegia

Keywords

stroke; hemiplegia; rehabilitation; robotics; neuroplasticity

Outcome Measures

Primary Outcomes (3)

• Fugl Meyer

  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.

  At 0 weeks

• 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

  At Session 0. Pre-intervention

• Tracking Accuracy

  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.

  At Session 0

Secondary Outcomes (3)

• Grip Strength

  pre-intervention

• Montreal Cognitive Assessment (MOCA)

  pre-intervention

• Becks Depression Scale

  Pre-intervention

Study Arms (1)

Stroke survivors with low and moderate motor deficits

OTHER

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

Interventions

Haptic Robot Therapy with Games DEVICE

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.

Stroke survivors with low and moderate motor deficits

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Medicine Rittenhouse

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (3)

• 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.

  PMID: 19963475 BACKGROUND

• 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. doi: 10.1109/IEMBS.2006.259971.

  PMID: 17946851 BACKGROUND

• 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.

  PMID: 24968380 BACKGROUND

Related Links

• A computer model of the human arm: Predictive biomechanics for the theradrive rehabilitation system

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michelle J Johnson
• Organization: University of Pennsylvania

johnmic@pennmedicine.upenn.edu

215 893-2665

Study Officials

• Michelle J Johnson, PhD

  PENN MEDICINE RITTENHOUSE

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: May 16, 2016
• Study Start: March 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 4, 2020
• Results First Posted: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)