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

• ClinicalTrials.gov Identifier: NCT04536987
• Recruitment Status: Completed
• First Posted: September 3, 2020
• Last Update Posted: September 3, 2020
• Sponsor: The Catholic University of America
• Collaborator: MedStar National Rehabilitation Network
• Information provided by (Responsible Party): The Catholic University of America

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Stroke; Movement Disorders; Hemiparesis	Device: HEXORR	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Random assignment to two study groups
• Masking: Single (Outcomes Assessor)
• Masking Description: Staff performing clinical evaluations was unaware of the study design.
• Primary Purpose: Treatment
• Official Title: Robot Therapy for Rehabilitation of Hand Movement After Stroke
• Actual Study Start Date: October 4, 2012
• Actual Primary Completion Date: January 15, 2017
• Actual Study Completion Date: January 15, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: low-dosage robot therapy; 12 sessions of robotic therapy over 4-5 weeks	Device: HEXORR; 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	Device: HEXORR; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Fugl-Meyer Test of Motor Function [ Time Frame: 6 month follow-up ]
   Measures motor impairment in the upper extremity after stroke

Secondary Outcome Measures :

1. Change in Action Research Arm Test [ Time Frame: 6 month follow-up ]
   Measures functional limitations of the upper extremity
2. 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.
3. Change in Modified Ashworth Test [ Time Frame: 6 month follow-up ]
   Measures hypertonia in the flexors of the fingers, wrist and elbow joints
4. Change in Motor Activity Log [ Time Frame: 6 month follow-up ]
   Measures the amount of use of the upper extremity in ADL
5. Change in Grip Strength [ Time Frame: 6 month follow-up ]
   Jamar Dynamometer

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, District of Columbia

MedStar National Rehabilitation Network

Washington, District of Columbia, United States, 20010

Sponsors and Collaborators

The Catholic University of America

MedStar National Rehabilitation Network

Investigators

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

More Information

Publications:

Godfrey SB, Holley RJ, Lum PS. Evaluation of HEXORR Tone Assistance Mode Against Spring Assistance. IEEE Trans Neural Syst Rehabil Eng. 2015 Jul;23(4):610-7. doi: 10.1109/TNSRE.2015.2398933. Epub 2015 Feb 4.

Godfrey SB, Holley RJ, Lum PS. Clinical effects of using HEXORR (Hand Exoskeleton Rehabilitation Robot) for movement therapy in stroke rehabilitation. Am J Phys Med Rehabil. 2013 Nov;92(11):947-58. doi: 10.1097/PHM.0b013e31829e7a07.

Schabowsky CN, Godfrey SB, Holley RJ, Lum PS. Development and pilot testing of HEXORR: hand EXOskeleton rehabilitation robot. J Neuroeng Rehabil. 2010 Jul 28;7:36. doi: 10.1186/1743-0003-7-36.

• Responsible Party: The Catholic University of America
• ClinicalTrials.gov Identifier: NCT04536987
• Other Study ID Numbers: 2012-315
• First Posted: September 3, 2020
• Last Update Posted: September 3, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: There is no plan to share data.

• 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

Keywords provided by The Catholic University of America:

robotic therapy; finger; hand

Additional relevant MeSH terms:

Stroke; Movement Disorders; Paresis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations