Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke

NCT05854485 | Completed DMC

• 1 other identifier: HP-00105650
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to investigate the efficacy of a hybrid-based rehabilitation program for the upper extremity(UE) combining the interventions- Functional Electrical Stimulation (FES) and Robotic rehabilitation in individuals with chronic stroke. The main question it aims to answer is if the Hybrid multi-muscle FES+Robot upper extremity rehabilitation is more effective in improving the upper extremity motor impairments and function as compared to robotic upper extremity training alone.

Conditions

Stroke

Keywords

Stroke Rehabilitation; Robotic Rehabilitation; Functional Electrical Stimulation

Outcome Measures

Primary Outcomes (3)

• Kinematic Assessment:Smoothness in 1/s2

  This measure will be collected as the participants performs target reaching out and in movements of the arm. Smoothness will be collected from the REACH robotic device to determine the kinematic changes in the reaching movements. Kinereach/trakStar system will also be utilized to conduct kinematic assessment and determine the translation of training effects into functional upper extremity use.

  Change from Baseline Smoothness at 6 weeks

• Kinematic Assessment:Speed in cm/seconds

  This measure will be collected as the participants performs target reaching out and in movements of the arm. Speed will be collected from the REACH robotic device to determine the kinematic changes in the reaching movements. Kinereach/trakStar system will also be utilized to conduct kinematic assessment and determine the translation of training effects into functional upper extremity use.

  Change from Baseline Speed at 6 weeks

• Kinematic Assessment:Range of Motion(ROM) in cms

  This measure will be collected as the participants performs target reaching out and in movements of the arm. ROM will be collected from the REACH robotic device to determine the kinematic changes in the reaching movements. Kinereach/trakStar system will also be utilized to conduct kinematic assessment and determine the translation of training effects into functional upper extremity use.

  Change from Baseline ROM at 6 weeks

Secondary Outcomes (3)

• Fugl-Meyer Upper Extremity(FMA-UE)

  Change from Baseline FMA-UE at 6 weeks

• Modified Ashworth Scale of muscle spasticity (MAS)

  Change from Baseline MAS at 6 weeks

• Wolf Motor Function Test (WMFT)

  Change from Baseline WMFT at 6 weeks

Study Arms (2)

Hybrid multi-muscle FES+Robot

EXPERIMENTAL

Participants will be receive hybrid upper extremity training involving the combination of REACH robotic device and multi-muscle FES. Water based electrodes will be positioned on the Triceps, Anconeus, wrist and finger extensors. Stimulation intensity of FES will be set at the participants tolerance level. The FES induced muscle contraction timing will be triggered in synchrony with the robotic movement. The training will be a multi-directional reach movement and hand opening re-training.

Combination Product: REACH robotic training and multi-muscle Functional Electrical Stimulation (FES) group

Robot only

ACTIVE COMPARATOR

Participants will receive upper extremity training with the REACH robotic device. The training will be a multi-directional reach movement re-training.

Combination Product: Robot only group

Interventions

REACH robotic training and multi-muscle Functional Electrical Stimulation (FES) group COMBINATION_PRODUCT

Participants in this group will receive multi-muscle FES during arm robotic training

Hybrid multi-muscle FES+Robot

Robot only group COMBINATION_PRODUCT

Participants in this group will receive arm robotic training only

Robot only

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with chronic stroke(\>6months post stroke)
• Age-22-85 years old
• Ability to perform a Upper Extremity forward reach of about 3 inches

You may not qualify if:

• Upper Extremity co-morbidities-pain, arthritis, and other neurological disorders
• Unable to tolerate electrical stimulation
• Have implants such as pacemaker, spinal cord or deep brain stimulator
• Have an elbow contracture of greater than 150 degrees
• Receiving Botox injections within 3 months

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Related Publications (10)

• Resquin F, Cuesta Gomez A, Gonzalez-Vargas J, Brunetti F, Torricelli D, Molina Rueda F, Cano de la Cuerda R, Miangolarra JC, Pons JL. Hybrid robotic systems for upper limb rehabilitation after stroke: A review. Med Eng Phys. 2016 Nov;38(11):1279-1288. doi: 10.1016/j.medengphy.2016.09.001. Epub 2016 Sep 29.

  PMID: 27692878 BACKGROUND

• Hughes AM, Freeman CT, Burridge JH, Chappell PH, Lewin PL, Rogers E. Feasibility of iterative learning control mediated by functional electrical stimulation for reaching after stroke. Neurorehabil Neural Repair. 2009 Jul-Aug;23(6):559-68. doi: 10.1177/1545968308328718. Epub 2009 Feb 3.

  PMID: 19190087 BACKGROUND

• Duret C, Grosmaire AG, Krebs HI. Robot-Assisted Therapy in Upper Extremity Hemiparesis: Overview of an Evidence-Based Approach. Front Neurol. 2019 Apr 24;10:412. doi: 10.3389/fneur.2019.00412. eCollection 2019.

  PMID: 31068898 BACKGROUND

• Kahn LE, Zygman ML, Rymer WZ, Reinkensmeyer DJ. Robot-assisted reaching exercise promotes arm movement recovery in chronic hemiparetic stroke: a randomized controlled pilot study. J Neuroeng Rehabil. 2006 Jun 21;3:12. doi: 10.1186/1743-0003-3-12.

  PMID: 16790067 BACKGROUND

• Volpe BT, Lynch D, Rykman-Berland A, Ferraro M, Galgano M, Hogan N, Krebs HI. Intensive sensorimotor arm training mediated by therapist or robot improves hemiparesis in patients with chronic stroke. Neurorehabil Neural Repair. 2008 May-Jun;22(3):305-10. doi: 10.1177/1545968307311102. Epub 2008 Jan 9.

  PMID: 18184932 BACKGROUND

• Ambrosini E, Zajc J, Ferrante S, Ferrigno G, Gasperina SD, Bulgheroni M, Baccinelli W, Schauer T, Wiesener C, Russold M, Gfoehler M, Puchinger M, Weber M, Becker S, Krakow K, Immick N, Augsten A, Rossini M, Proserpio D, Gasperini G, Molteni F, Pedrocchi A. A Hybrid Robotic System for Arm Training of Stroke Survivors: Concept and First Evaluation. IEEE Trans Biomed Eng. 2019 Dec;66(12):3290-3300. doi: 10.1109/TBME.2019.2900525. Epub 2019 Jun 5.

  PMID: 31180833 BACKGROUND

• Collins KC, Kennedy NC, Clark A, Pomeroy VM. Kinematic Components of the Reach-to-Target Movement After Stroke for Focused Rehabilitation Interventions: Systematic Review and Meta-Analysis. Front Neurol. 2018 Jun 25;9:472. doi: 10.3389/fneur.2018.00472. eCollection 2018.

  PMID: 29988530 BACKGROUND

• Turner DL, Ramos-Murguialday A, Birbaumer N, Hoffmann U, Luft A. Neurophysiology of robot-mediated training and therapy: a perspective for future use in clinical populations. Front Neurol. 2013 Nov 13;4:184. doi: 10.3389/fneur.2013.00184.

  PMID: 24312073 BACKGROUND

• Moon SH, Choi JH, Park SE. The effects of functional electrical stimulation on muscle tone and stiffness of stroke patients. J Phys Ther Sci. 2017 Feb;29(2):238-241. doi: 10.1589/jpts.29.238. Epub 2017 Feb 24.

  PMID: 28265148 BACKGROUND

• Rao S, Boettger B, Alon G, Whitall J, Hennessie B, Roy A, P Westlake K. Extending reach: hybrid robotic-functional electrical stimulation training for post-stroke upper extremity rehabilitation. J Neuroeng Rehabil. 2026 Mar 16. doi: 10.1186/s12984-026-01942-7. Online ahead of print. No abstract available.

  PMID: 41840604 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

proto-oncogene protein c-fes-fps; Population Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 11, 2023
• Study Start: September 6, 2023
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 23, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)