Robot Therapy for Rehabilitation of Hand Movement After Stroke

NCT04536987 | Completed Phase 2 FDA Device

• 1 other identifier: 2012-315
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Movement Disorders; Hemiparesis

Keywords

robotic therapy; finger; hand

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer Test of Motor Function

  Measures motor impairment in the upper extremity after stroke

  6 month follow-up

Secondary Outcomes (5)

• Change in Action Research Arm Test

  6 month follow-up

• Change in finger extension range of motion (degrees)

  6 month follow-up

• Change in Modified Ashworth Test

  6 month follow-up

• Change in Motor Activity Log

  6 month follow-up

• Change in Grip Strength

  6 month follow-up

Study Arms (2)

low-dosage robot therapy

EXPERIMENTAL

12 sessions of robotic therapy over 4-5 weeks

Device: HEXORR

hi-dosage robot therapy

EXPERIMENTAL

24 sessions of robotic therapy over 8-10 weeks

Device: HEXORR

Interventions

HEXORR DEVICE

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.

hi-dosage robot therapy; low-dosage robot therapy

Eligibility Criteria

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

You may qualify if:

• a diagnosis of stroke more than 6 months prior to randomization
• 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 Mini-Mental Status Examination score \>24

You may not qualify if:

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

Sponsors & Collaborators

• The Catholic University of America: lead
• MedStar National Rehabilitation Network: collaborator

Study Sites (1)

MedStar National Rehabilitation Network

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (3)

• 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.

  PMID: 25667355 BACKGROUND

• 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.

  PMID: 23900016 BACKGROUND

• 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.

  PMID: 20667083 BACKGROUND

MeSH Terms

Conditions

Stroke; Movement Disorders; Paresis

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter Lum

  The Catholic University of America

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Staff performing clinical evaluations was unaware of the study design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Random assignment to two study groups

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: September 3, 2020
• Study Start: October 4, 2012
• Primary Completion: January 15, 2017
• Study Completion: January 15, 2017
• Last Updated: September 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)