Robotic Training for Stroke Neurorehabilitation

NCT02639390 | Terminated Phase 2 Results

• 1 other identifier: A1966-R
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal is to further develop a robotic exoskeleton for neurorehabilitation of arm function after stroke. The investigators previously developed a novel training protocol that combined the ARMin and HandSOME exoskeletons. This is one of only a few arm exoskeletons that allow coordinated whole limb training in reach and grasp tasks with both virtual and real objects. However, the robot has a very large inertia and friction, and only gross grasp patterns are available. In development work, the investigators will significantly modify the AMRin and HandSOME to deliver a state-of-the-art lightweight robotic exoskeleton capable of retraining a wide range of functional activities. In the subsequent testing phase, a clinical trial will examine the effects of robotic training in chronic stroke subjects.

Conditions

Stroke

Keywords

Robotics; upper extremity; neurorehabilitation; movement therapy

Outcome Measures

Primary Outcomes (6)

• Change in Fugl-Meyer Score

  The Fugl-Meyer Test of Motor Function will be used to assess motor impairments at the shoulder, elbow, wrist and fingers. The Fugl-Meyer test scores reflexes and the ability to perform several movements and tasks on a 3-point scale. The Fugl-Meyer was designed for the recovery patterns observed after stroke and is very responsive to change in severe and moderately impaired subjects.

  Change from baseline to 8 weeks

• Change in Action Research Arm Test

  The Action Research Arm Test (ARAT) is an impairment level measurement tool that assesses the functional limitations of the upper extremities. It is one of the most frequently used primary endpoints in upper extremity (UE) training trials in stroke. The assessment incorporates 19 items that are divided into four subscales: Grasp, Grip, Pinch, and Gross movement. Item scores are summed to form a subtest score, and then a full-scale score.

  Change from baseline to 8 weeks

• Change in Motor Activity Log

  The Motor Activity Log (MAL) will be used to assess use of the limb at home. It is a structured interview during which respondents are asked to rate how they use their more-impaired arm for 28 activities of daily living (ADL) in the home over a specified period. Activities include brushing teeth, buttoning a shirt or blouse, and eating with a fork or spoon.

  Change from baseline to 8 weeks

• Change in Fugl-Meyer Score at Follow-up

  The Fugl-Meyer Test of Motor Function will be used to assess motor impairments at the shoulder, elbow, wrist and fingers. The Fugl-Meyer test scores reflexes and the ability to perform several movements and tasks on a 3-point scale. The Fugl-Meyer was designed for the recovery patterns observed after stroke and is very responsive to change in severe and moderately impaired subjects.

  Change from baseline to 8 months

• Change in Action Research Arm Test at Follow-up

  The Action Research Arm Test (ARAT) is an impairment level measurement tool that assesses the functional limitations of the upper extremities. It is one of the most frequently used primary endpoints in upper extremity (UE) training trials in stroke. The assessment incorporates 19 items that are divided into four subscales: Grasp, Grip, Pinch, and Gross movement. Item scores are summed to form a subtest score, and then a full-scale score.

  Change from baseline to 8 months

• Change in Motor Activity Log at Follow-up

  The Motor Activity Log (MAL) will be used to assess use of the limb at home. It is a structured interview during which respondents are asked to rate how they use their more-impaired arm for 28 activities of daily living (ADL) in the home over a specified period. Activities include brushing teeth, buttoning a shirt or blouse, and eating with a fork or spoon.

  Change from baseline to 8 months

Study Arms (2)

Robotic

EXPERIMENTAL

The experimental group will receive 1-hour robotic training sessions, 3 times per week for a total of 12 sessions supervised by a research assistant. Immediately following this robot training, these subjects will receive the same dosage and schedule (1-hour sessions, 3 times/week, 12 total sessions) of conventional one-on-one therapy from an occupational therapist.

Device: Robotic Therapy; Other: Conventional Therapy

Conventional

ACTIVE COMPARATOR

Subjects will receive 24 hours of one-on-one treatment from an occupational therapist. The treatment schedule will parallel that given to the experimental group (1-hour sessions, 3 times/week).

Other: Conventional Therapy

Interventions

Robotic Therapy DEVICE

Subjects will be placed in the robot and practice common upper extremity tasks involving grasping, manipulating and moving objects.

Robotic

Conventional Therapy OTHER

An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement.

Conventional; Robotic

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 or older
• Ischemic or hemorrhagic stroke (with confirmatory neuroimaging) that occurred more than 6 months before entering the study
• Presence of voluntary hand activity indicated by a score of at least 1 on the finger mass extension/grasp release item of the Fugl-Meyer Test of Motor Function
• Adequate cognitive status, as determined by clinical evaluation
• No upper extremity injury or conditions that limited use prior to the stroke

You may not qualify if:

• Cannot give informed consent
• Have clinically significant fluctuations in mental status within a month of enrollment
• Were not independent prior to the stroke as measured by scores \<95 on the Barthel Index or \>1 on the Modified Rankin Scale
• Have hemispatial neglect as determined by \>3 errors on the Star Cancellation Test
• Have severe sensory loss as determined by a score of 2 on the sensory item of the NIHSS
• Receiving oral or injected antispasticity medications during study treatment
• Pain that interferes with daily activities
• History of prior stroke

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Peter Lum
• Organization: Department of Veterans Affairs

lum@cua.edu

12023195181

Study Officials

• Peter S. Lum, PhD

  Washington DC VA Medical Center, Washington, DC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 24, 2015
• Study Start: May 7, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 13, 2021
• Results First Posted: November 12, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)