Robot Therapy for Rehabilitation of Hand Movement After Stroke (HEXORR)

August 28, 2020 updated by: The Catholic University of America
A study will be performed where individuals with chronic stroke will be randomly assigned to receive 2 different dosages of robotic hand therapy. One group will receive 12 sessions of robot-assisted repetitive movement practice in the HEXORR robot over a 4-5 week period. A second group will receive 24 sessions of HEXORR therapy over a 8-10 week period.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The overall goal of the proposed work is to improve hand function after stroke. Adequate hand function is critical to a functional upper limb, and is often resistant to conventional therapeutic interventions. Many stroke survivors have residual ability to flex the fingers, but extension is often limited and impeded by increased passive stiffness in flexors, involuntary activation of flexors and inability to activate extensors. The rationale for this approach stems from the growing evidence that neuro-rehabilitation after stroke may be enhanced via the application of motor learning strategies within the context of repetitive movement practice. The key therapeutic aspects of these strategies are high repetition, volitional effort, and successful completion of tasks to prevent frustration. While these represent promising therapeutic strategies, they are limited to mildly impaired subjects who already have enough control of finger extension to tolerate high repetitions of grasp/release tasks without succumbing to fatigue and/or frustration. There is a very large population of stroke patients who don't fall into this category and often must rely on compensatory strategies. In these patients, repetitive task practice facilitated by a robotic device may be more effective than unassisted task practice.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar National Rehabilitation Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. a diagnosis of stroke more than 6 months prior to randomization
  2. 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
  3. adequate cognitive status, as determined by Mini-Mental Status Examination score >24

Exclusion Criteria:

  1. were under the influence of oral or injected antispasticity medications during the study
  2. had MCP and IP passive extension limit > 30 degrees from full extension
  3. had pain that interfered with daily activities
  4. had excessive tone in the fingers and thumb as determined by Ashworth scores >=3
  5. had severe sensory loss or hemispatial neglect as determined by clinical exam.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: low-dosage robot therapy
12 sessions of robotic therapy over 4-5 weeks
The subject receives robotic assistance from the HEXORR robot during finger and thumb movements. Several different video games are used to provide feedback of performance and motivate the training. The assistance level is adjusted automatically in some games and manually in other games to enable a target success rate of 67% when playing the games.
EXPERIMENTAL: hi-dosage robot therapy
24 sessions of robotic therapy over 8-10 weeks
The subject receives robotic assistance from the HEXORR robot during finger and thumb movements. Several different video games are used to provide feedback of performance and motivate the training. The assistance level is adjusted automatically in some games and manually in other games to enable a target success rate of 67% when playing the games.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fugl-Meyer Test of Motor Function
Time Frame: 6 month follow-up
Measures motor impairment in the upper extremity after stroke
6 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Action Research Arm Test
Time Frame: 6 month follow-up
Measures functional limitations of the upper extremity
6 month follow-up
Change in finger extension range of motion (degrees)
Time Frame: 6 month follow-up
Motion capture of finger and thumb movement will be used to assess extension ability in units of degrees. The task will be to open the hand as far as possible from a closed fist. Data from all digits will be averaged to provide a single metric for extension ability of the fingers and thumb.
6 month follow-up
Change in Modified Ashworth Test
Time Frame: 6 month follow-up
Measures hypertonia in the flexors of the fingers, wrist and elbow joints
6 month follow-up
Change in Motor Activity Log
Time Frame: 6 month follow-up
Measures the amount of use of the upper extremity in ADL
6 month follow-up
Change in Grip Strength
Time Frame: 6 month follow-up
Jamar Dynamometer
6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Peter Lum, The Catholic University of America

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 4, 2012

Primary Completion (ACTUAL)

January 15, 2017

Study Completion (ACTUAL)

January 15, 2017

Study Registration Dates

First Submitted

July 29, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (ACTUAL)

September 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 3, 2020

Last Update Submitted That Met QC Criteria

August 28, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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