ESTIM-UL: FES for Upper Limb Recovery After Stroke

NCT07513714 | Recruiting

• 1 other identifier: FoggiaFisiatria02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a leading cause of long-term disability, frequently resulting in impaired upper limb motor function and spasticity. Although Botulinum Toxin Type A (BoNT-A) is effective in reducing focal spasticity, functional recovery of the upper limb often remains limited without intensive, task-specific rehabilitation. Functional Electrical Stimulation (FES), when synchronized with voluntary movement during Task-Oriented Training, may enhance motor recovery by facilitating muscle activation and neuroplasticity. This randomized controlled trial aims to evaluate whether FES combined with Task-Oriented Training is superior to conventional Task-Oriented Training alone in improving upper limb function in post-stroke patients treated with BoNT-A.

Conditions

Stroke; Post-Stroke Spasticity; Post-Stroke Hemiparesis

Keywords

functional electrical stimulation; Botulinum Toxin Type A; stroke; motor recovery; upper limb

Outcome Measures

Primary Outcomes (1)

• Change in Gross Manual Dexterity

  Measured as the mean change in score on the Box and Block Test (BBT), defined as the difference in the number of blocks transferred in 60 seconds between baseline and post-treatment

  Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)

Secondary Outcomes (3)

• Upper Limb Muscle Strength

  Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)

• Upper Limb Muscle Tone

  Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)

• Spasticity-related Quality of Life 6-Dimensions (SQoL-6D)

  Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)

Study Arms (2)

Functional Electrical Stimulation plus Task-Oriented Training

EXPERIMENTAL

Participants in the experimental arm receive Task-Oriented Training of the affected upper limb with Functional Electrical Stimulation (FES) applied to upper limb muscles based on the movement. FES is delivered using a wireless stimulation system and is synchronized with the participant's voluntary movement attempts to facilitate active motor execution. The first module includes active Task-Oriented Training of the paretic upper limb, such as reaching, grasping, and object manipulation. During task execution, Functional Electrical Stimulation is applied to upepr limb muscles and is synchronized with the participant's voluntary movement attempts to facilitate active motor execution and provide proprioceptive feedback.The second module consists of conventional physiotherapy focused on joint mobilization (passive and active-assisted movements) and muscle stretching. Each session lasts 60 minutes and is conducted 5 days per week for 2 consecutive weeks (10 sessions total).

Device: Functional Electrical Stimulation (FES)

Task-Oriented Training with Conventional Rehabilitation

ACTIVE COMPARATOR

Participants in the control arm receive Task-Oriented Training of the affected upper limb with conventional manual facilitation provided by a physiotherapist, without electrical stimulation. The first module includes Task-Oriented Training of the paretic upper limb, such as reaching, grasping, and object manipulation. When required, assistance to movement is provided manually by the physiotherapist through neuromuscular facilitation techniques, without Functional Electrical Stimulation. The second module consists of conventional physiotherapy focused on joint mobilization and muscle stretching, identical to that delivered in the experimental arm. Each session lasts 60 minutes and is conducted 5 days per week for 2 consecutive weeks (10 sessions total).

Other: Conventional Rehabilitation

Interventions

Functional Electrical Stimulation (FES) DEVICE

Functional Electrical Stimulation is applied to wrist and finger extensor muscles of the paretic upper limb using a surface electrode system. Electrical stimulation is synchronized with the participant's voluntary movement attempts during Task-Oriented Training to facilitate active motor execution and sensorimotor integration. Stimulation is delivered during 60-minute rehabilitation sessions, 5 days per week for 2 consecutive weeks.

Functional Electrical Stimulation plus Task-Oriented Training

Conventional Rehabilitation OTHER

Conventional rehabilitation consists of therapist-assisted Task- Oriented Training of the paretic upper limb, including manual facilitation and guidance as needed to support task execution. No electrical stimulation is applied. Sessions last 60 minutes and are performed 5 days per week for 2 consecutive weeks.

Task-Oriented Training with Conventional Rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Diagnosis of ischemic or hemorrhagic stroke, documented by CT or MRI.
• Clinical presence of focal upper limb spasticity, defined as a score ≥ 1+ on the Modified Ashworth Scale (MAS) in at least one target muscle group (elbow, wrist, or finger flexors), treated with Botulinum Toxin Type A injection.
• Presence of residual voluntary muscle activation (minimal active movement) sufficient to initiate the motor task required by the training (Box and Block score ≥ 1).
• Preserved cognitive function, defined as a Mini-Mental State Examination (MMSE) score ≥ 24 or clinical judgment confirming adequate comprehension and cooperation.

You may not qualify if:

• Absolute contraindications to Functional Electrical Stimulation (FES), including the presence of a cardiac pacemaker or implantable cardioverter defibrillator (ICD), pharmacologically uncontrolled epilepsy, or skin lesions/dermatitis at the electrode application sites.
• Presence of severe muscle-tendon contractures or fixed joint deformities (ankylosis) that mechanically limit passive movement and make active functional recovery unlikely.
• Severe cognitive impairment, global aphasia, or severe unilateral spatial neglect that prevents task comprehension or active participation in the training program.
• Concomitant orthopedic or rheumatologic conditions affecting the upper limb (e.g., recent fractures, severe arthritis) that could interfere with treatment delivery or outcome assessment.

Sponsors & Collaborators

• University of Foggia: lead

Study Sites (1)

Università degli studi di Foggia

Foggia, Foggia, 71121, Italy

RECRUITING

Related Publications (10)

• Timmermans AA, Seelen HA, Willmann RD, Kingma H. Technology-assisted training of arm-hand skills in stroke: concepts on reacquisition of motor control and therapist guidelines for rehabilitation technology design. J Neuroeng Rehabil. 2009 Jan 20;6:1. doi: 10.1186/1743-0003-6-1.

  PMID: 19154570 BACKGROUND

• Lee JM, Gracies JM, Park SB, Lee KH, Lee JY, Shin JH. Botulinum Toxin Injections and Electrical Stimulation for Spastic Paresis Improve Active Hand Function Following Stroke. Toxins (Basel). 2018 Oct 25;10(11):426. doi: 10.3390/toxins10110426.

  PMID: 30366407 BACKGROUND

• Reebye R, Jacinto LJ, Balbert A, Biering-Sorensen B, Carda S, Draulans N, Molteni F, O'Dell MW, Picelli A, Santamato A, Verduzco-Gutierrez M, Walker H, Wissel J, Francisco GE. Multimodal therapy and use of adjunctive therapies to BoNT-A in spasticity management: defining terminology to help enhance spasticity treatment. Front Neurol. 2024 Aug 30;15:1432330. doi: 10.3389/fneur.2024.1432330. eCollection 2024.

  PMID: 39281409 BACKGROUND

• Chen HM, Chen CC, Hsueh IP, Huang SL, Hsieh CL. Test-retest reproducibility and smallest real difference of 5 hand function tests in patients with stroke. Neurorehabil Neural Repair. 2009 Jun;23(5):435-40. doi: 10.1177/1545968308331146. Epub 2009 Mar 4.

  PMID: 19261767 BACKGROUND

• Kwakkel G, van Wegen EEH, Burridge JH, Winstein CJ, van Dokkum LEH, Alt Murphy M, Levin MF, Krakauer JW; ADVISORY group. Standardized Measurement of Quality of Upper Limb Movement After Stroke: Consensus-Based Core Recommendations From the Second Stroke Recovery and Rehabilitation Roundtable. Neurorehabil Neural Repair. 2019 Nov;33(11):951-958. doi: 10.1177/1545968319886477. Epub 2019 Oct 29.

  PMID: 31660781 BACKGROUND

• Eraifej J, Clark W, France B, Desando S, Moore D. Effectiveness of upper limb functional electrical stimulation after stroke for the improvement of activities of daily living and motor function: a systematic review and meta-analysis. Syst Rev. 2017 Feb 28;6(1):40. doi: 10.1186/s13643-017-0435-5.

  PMID: 28245858 BACKGROUND

• Picelli A, Santamato A, Chemello E, Cinone N, Cisari C, Gandolfi M, Ranieri M, Smania N, Baricich A. Adjuvant treatments associated with botulinum toxin injection for managing spasticity: An overview of the literature. Ann Phys Rehabil Med. 2019 Jul;62(4):291-296. doi: 10.1016/j.rehab.2018.08.004. Epub 2018 Sep 13.

  PMID: 30219307 BACKGROUND

• Mills PB, Finlayson H, Sudol M, O'Connor R. Systematic review of adjunct therapies to improve outcomes following botulinum toxin injection for treatment of limb spasticity. Clin Rehabil. 2016 Jun;30(6):537-48. doi: 10.1177/0269215515593783. Epub 2015 Jul 21.

  PMID: 26198891 BACKGROUND

• Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.

  PMID: 27145936 BACKGROUND

• GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11.

  PMID: 30871944 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study uses a single-blind design. Outcome assessors are blinded to treatment allocation. Due to the nature of the intervention, participants and care providers are not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: md phd pmr Specialist

Model Details: Eligible participants are randomized in a 1:1 ratio to one of two parallel intervention groups. One group receives Functional Electrical Stimulation applied to wrist and finger extensor muscles during Task-Oriented Training, while the control group receives Task-Oriented Training with conventional manual facilitation. Both groups undergo the same treatment duration and intensity. Outcomes are assessed by a blinded evaluator at baseline, post-treatment, and follow-up.

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: April 7, 2026
• Study Start: May 1, 2026
• Primary Completion: October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)