StrokeNCT05854485

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

A study testing REACH robotic training and multi-muscle Functional Electrical Stimulation (FES) group and Robot only group in people with Stroke, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 22 to 85 years
Conditions the study is for: Stroke
What is being tested?: REACH robotic training and multi-muscle Functional Electrical Stimulation (FES) group and Robot only group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 6 Sep 2023to 30 Jun 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Maryland School of Medicine
Baltimore, Maryland, 21201

Other trials in United States

About this study

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.

Read the detailed description

Individuals with chronic stroke(> 6months after stroke) will be recruited. All participants will complete clinical and kinematic assessments at 2 time points(baseline and after 6 weeks training). Each participant will receive 18 sessions of 60 minute upper extremity training over 6 weeks.

Study participants will be randomly assigned to receive either of the following upper extremity training- 1. Hybrid multi-muscle FES+Robot training group or 2.Robot only training group.

The following clinical assessments to measure the motor impairments and functional recovery will be performed: Fugl-Meyer Upper Extremity, Modified Ashworth Scale, and Wolf Motor Function Test.

Kinematic assessments will be conducted using the REACH robotic device and the Kinereach/trakStar system. The following kinematic parameters will be collected: Smoothness, Range of Motion, and Speed.

Conditions: Stroke
Being tested: REACH robotic training and multi-muscle Functional Electrical Stimulation (FES) group, Robot only group
Keywords: Stroke Rehabilitation, Robotic Rehabilitation, Functional Electrical Stimulation
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

REACH robotic training and multi-muscle Functional Electrical Stimulation (FES) groupCombination product
Participants in this group will receive multi-muscle FES during arm robotic training
Robot only groupCombination product
Participants in this group will receive arm robotic training only

Study groups in NCT05854485
Study group	Role	What they receive
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. Receives: 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. Receives: Combination Product: Robot only group

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline ROM at 6 weeks

Secondary outcomes (3)

Fugl-Meyer Upper Extremity(FMA-UE)
FMA-UE is a standard measure for the clinical assessment of motor impairment. FMA mainly evaluates the degree of synergy pattern during volitional movements, along with reflex activity and coordination. It is based on 33 items and scores range from 0 to 66. A higher score means better motor function.
Measured: Change from Baseline FMA-UE at 6 weeks
Modified Ashworth Scale of muscle spasticity (MAS)
The MAS is a measurement of spasticity across specific muscle groups. The grading of spasticity ranges from 0 to 5 with higher score indicating worse functioning.
Measured: Change from Baseline MAS at 6 weeks
Wolf Motor Function Test (WMFT)
WMFT is a function based test designed to measure upper extremity movements and movement speed during functional tasks. The WMFT consists of 17 items, of which 15 measure time to perform functional tasks and 2 strength-based tasks. Two types of scores are recorded during the task:WMFT-TIME(time of the task) and WMFT-FAS (functional abilities). The maximum score of WMFT-TIME is 120 seconds, and a higher score means slower movement. WMFT-FAS is scored from 0 to 5, and a higher score indicates higher level of functional performance, better quality of the paretic upper extremity during the task.
Measured: Change from Baseline WMFT at 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 202330 Jun 2025

First posted11 May 2023
Study start6 Sep 2023
Primary completion30 May 2025
Study completion30 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05854485
Sponsor's protocol ID: HP-00105650
Status last verified: Sep 2024
First submitted: 18 Apr 2023
Last updated: 23 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 27692878
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.
PubMed 19190087
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.
PubMed 31068898
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.
PubMed 16790067
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.
PubMed 18184932
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.
PubMed 31180833
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.
PubMed 29988530
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.
PubMed 24312073
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.
PubMed 28265148
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;23(1):146. doi: 10.1186/s12984-026-01942-7.
PubMed 41840604

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
ClinicalTrials.gov ID: NCT05854485
Acronym / sponsor ID: HP-00105650
Conditions: Stroke
Keywords: Stroke Rehabilitation, Robotic Rehabilitation, Functional Electrical Stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Study start: 6 Sep 2023 (actual)
Primary completion: 30 May 2025 (actual)
Study completion: 30 Jun 2025 (actual)
First posted: 11 May 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study participants will be randomly assigned to receive either of the following upper extremity training- 1. Hybrid multi-muscle FES+Robot training group or 2.Robot only training group.

The following clinical assessments to measure the motor impairments and functional recovery will be performed: Fugl-Meyer Upper Extremity, Modified Ashworth Scale, and Wolf Motor Function Test.

Kinematic assessments will be conducted using the REACH robotic device and the Kinereach/trakStar system. The following kinematic parameters will be collected: Smoothness, Range of Motion, and Speed.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Hybrid multi-muscle FES+Robot	Experimental	Combination Product: REACH robotic training and multi-muscle Functional Electrical Stimulation (FES) groupParticipants 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.
Robot only	Active comparator	Combination Product: Robot only groupParticipants will receive upper extremity training with the REACH robotic device. The training will be a multi-directional reach movement re-training.

Who may qualify

Ages: 22 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
REACH robotic training and multi-muscle Functional Electrical Stimulation (FES) groupParticipants in this group will receive multi-muscle FES during arm robotic training	Combination product	Hybrid multi-muscle FES+Robot
Robot only groupParticipants in this group will receive arm robotic training only	Combination product	Robot only

Primary outcome

Kinematic Assessment:Smoothness in 1/s2
Time frame: Change from Baseline Smoothness at 6 weeks
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.
Kinematic Assessment:Speed in cm/seconds
Time frame: Change from Baseline Speed at 6 weeks
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.
Kinematic Assessment:Range of Motion(ROM) in cms
Time frame: Change from Baseline ROM at 6 weeks
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.

3 secondary outcomes

Fugl-Meyer Upper Extremity(FMA-UE)
Time frame: Change from Baseline FMA-UE at 6 weeks
Modified Ashworth Scale of muscle spasticity (MAS)
Time frame: Change from Baseline MAS at 6 weeks
Wolf Motor Function Test (WMFT)
Time frame: Change from Baseline WMFT at 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
Background: PubMed 27692878Resquin 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.
Background: PubMed 19190087Hughes 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.
Background: PubMed 31068898Duret 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.
Background: PubMed 16790067Kahn 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.
Background: PubMed 18184932Volpe 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.
Background: PubMed 31180833Ambrosini 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.
Background: PubMed 29988530Collins 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.
Background: PubMed 24312073Turner 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.
Background: PubMed 28265148Moon 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.
Derived from this study: PubMed 41840604Rao 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;23(1):146. doi: 10.1186/s12984-026-01942-7.
Individual participant dataSharing planned: No

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kinematic Assessment:Smoothness in 1/s2 (time frame: Change from Baseline Smoothness at 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05854485, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.