Effects of Using Advanced NEUROrehabilitation TECHnologies in Upper Limb Motor Function and Capacity Recovery in People With Stroke

NCT07698405 | Recruiting

• 1 other identifier: NEURO-TECH
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of a personalized technology-based rehabilitative intervention on Upper Limb (UL) motor function and capacity recovery in People with Stroke (PwS). The study is single-cohort study in which eligible participants will undergo baseline and follow-up clinical and instrumental assessments over a 4-5 week period. The intervention consists of a personalized and specific upper limb technology-based rehabilitation programme delivered three times per week for a total of 12-15 sessions. Each session lasts approximately one hour and is integrated with conventional rehabilitation treatments. Primary outcomes include Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT). Secondary outcomes include instrumental assessment of active range of motion and grip strength.

Conditions

Stroke

Keywords

Stroke; Technology-Assisted Rehabilitation; Robotics; Virtual Reality; Motor Recovery

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

  Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is an ordinal scale used to assess sensorimotor function following stroke. The upper extremity motor function section includes four subscales assessing synergistic and non-synergistic movements of shoulder, elbow, wrist and hand, as well as coordination/speed. The maximum score is 66 points, indicating normal upper limb motor function. In addition to motor function, the FMA-UE assesses Non-motor domains (i.e., sensation, passive joint movement and pain), with a maximum total score of 60 points.

  Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)

• Action Research Arm Test (ARAT)

  Action Research Arm Test (ARAT) consists of 19 items grouped in subtests (i.e., grasp, grip, pinch, and gross arm movement) and performance of each item rated on a 4 points scale (from 0 - no movement possible, to 3 - movement performed normally.

  Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)

Secondary Outcomes (2)

• Instrumented Active Range of Motion (AROM) of affected Upper Limb

  Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)

• Instrumental gross and fine motor grip strength of hand affected

  Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)

Other Outcomes (8)

• National Institute of Health Stroke Scale Italian version (NIHSS-IT)

  Baseline (T0) at enrollment

• Oxford Community Stroke Project (OCSP)

  Baseline (T0) at enrollment

• Modified Ashworth Scale (MAS)

  Baseline (T0) at enrollment

Study Arms (1)

PwS

Adult People with Stroke (PwS) with Upper Limb (UL) motor function impairment

Device: Technology-based UL rehabilitation

Interventions

Technology-based UL rehabilitation DEVICE

Participants will receive conventional treatments, including neuromotor, occupational therapy, speech therapy and/or neuropsychology treatments, as clinically indicated. In addition, they will undergo a personalized and specific UL technology-based rehabilitation programme, delivered 3 times per week, for a total of 12 - 15 sessions. Each session will last 1 hour and will be conducted in a 1:1 format (physiotherapist : participant). Data on rehabilitation dosage will be collected, including the total number of hours of rehabilitation received. Physiotherapists who will have in charge participant, will compiled a treatment diary for each technology session in which they will record: number of session, total hour of technology-based treatments, type of device used and any adverse events.

PwS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult PwS admitted to the Intensive Rehabilitation Unit at Fiorenzuola d'Arda hospital. Sampling will be consecutive and carried out on the basis of feasibility and the flow of admissions to the Clinical Unit, amounting to approximately 3-5 individuals per month. The study will include PwS who meet eligibility criteria at the time of recruitment and who are able to understand and provide informed consent to participate.

You may qualify if:

• Age ≥ 18 years;
• First-ever unilateral ischemic or hemorrhagic stroke;
• Presence of upper limb motor impairment;
• Modified Ashworth Scale (MAS) \< 3;
• Montreal Cognitive Assessment (MoCA) \> 24;
• Medically stable and able to participate in an intensive rehabilitation programme;
• Ability to understand and follow study procedures;
• Written informed consent.

You may not qualify if:

• Diagnosis of severe aphasia, based on medical records, preventing participation;
• Bilateral hemisphere lesions;
• Severe and unstable medical conditions (e.g. untreated seizure, heart failure) that preclude participation in rehabilitation;
• Other neurological and/or psychiatric diseases;
• Recent and unstabilized upper limb fracture.

Sponsors & Collaborators

• Azienda Unita Sanitaria Locale di Piacenza: lead

Study Sites (1)

Fiorenzuola d'Arda Hospital - AUSL Piacenza

Fiorenzuola d'Arda, Piacenza, 29017, Italy

RECRUITING

Related Publications (17)

• Saposnik G, Levin M; Outcome Research Canada (SORCan) Working Group. Virtual reality in stroke rehabilitation: a meta-analysis and implications for clinicians. Stroke. 2011 May;42(5):1380-6. doi: 10.1161/STROKEAHA.110.605451. Epub 2011 Apr 7.

  PMID: 21474804 BACKGROUND

• Yoo SD, Lee HH. The Effect of Robot-Assisted Training on Arm Function, Walking, Balance, and Activities of Daily Living After Stroke: A Systematic Review and Meta-Analysis. Brain Neurorehabil. 2023 Sep 20;16(3):e24. doi: 10.12786/bn.2023.16.e24. eCollection 2023 Nov.

  PMID: 38047093 BACKGROUND

• O'Flaherty D, Ali K. Recommendations for Upper Limb Motor Recovery: An Overview of the UK and European Rehabilitation after Stroke Guidelines (2023). Healthcare (Basel). 2024 Jul 18;12(14):1433. doi: 10.3390/healthcare12141433.

  PMID: 39057576 BACKGROUND

• Collin C, Wade D. Assessing motor impairment after stroke: a pilot reliability study. J Neurol Neurosurg Psychiatry. 1990 Jul;53(7):576-9. doi: 10.1136/jnnp.53.7.576.

  PMID: 2391521 BACKGROUND

• Kwakkel G, Kollen BJ, Krebs HI. Effects of robot-assisted therapy on upper limb recovery after stroke: a systematic review. Neurorehabil Neural Repair. 2008 Mar-Apr;22(2):111-21. doi: 10.1177/1545968307305457. Epub 2007 Sep 17.

  PMID: 17876068 BACKGROUND

• Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.

  PMID: 24505342 BACKGROUND

• Mehrholz J, Pollock A, Pohl M, Kugler J, Elsner B. Systematic review with network meta-analysis of randomized controlled trials of robotic-assisted arm training for improving activities of daily living and upper limb function after stroke. J Neuroeng Rehabil. 2020 Jun 30;17(1):83. doi: 10.1186/s12984-020-00715-0.

  PMID: 32605587 BACKGROUND

• MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

  PMID: 14258950 BACKGROUND

• Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.

  PMID: 3160243 BACKGROUND

• McDonnell M. Action research arm test. Aust J Physiother. 2008;54(3):220. doi: 10.1016/s0004-9514(08)70034-5. No abstract available.

  PMID: 18833688 BACKGROUND

• Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.

  PMID: 1135616 BACKGROUND

• Lang CE, Edwards DF, Birkenmeier RL, Dromerick AW. Estimating minimal clinically important differences of upper-extremity measures early after stroke. Arch Phys Med Rehabil. 2008 Sep;89(9):1693-700. doi: 10.1016/j.apmr.2008.02.022.

  PMID: 18760153 BACKGROUND

• Arya KN, Verma R, Garg RK. Estimating the minimal clinically important difference of an upper extremity recovery measure in subacute stroke patients. Top Stroke Rehabil. 2011 Oct;18 Suppl 1:599-610. doi: 10.1310/tsr18s01-599.

  PMID: 22120029 BACKGROUND

• Cicerone Consensus Conference. Linee di indirizzo per l'utilizzo delle tecnologie riabilitative. Consensus Conference CICERONE 2022

  BACKGROUND

• Loureiro RC, Harwin WS, Nagai K, Johnson M. Advances in upper limb stroke rehabilitation: a technology push. Med Biol Eng Comput. 2011 Oct;49(10):1103-18. doi: 10.1007/s11517-011-0797-0. Epub 2011 Jul 20.

  PMID: 21773806 BACKGROUND

• Veerbeek JM, Langbroek-Amersfoort AC, van Wegen EE, Meskers CG, Kwakkel G. Effects of Robot-Assisted Therapy for the Upper Limb After Stroke. Neurorehabil Neural Repair. 2017 Feb;31(2):107-121. doi: 10.1177/1545968316666957. Epub 2016 Sep 24.

  PMID: 27597165 BACKGROUND

• GBD 2021 Stroke Risk Factor Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Neurol. 2024 Oct;23(10):973-1003. doi: 10.1016/S1474-4422(24)00369-7.

  PMID: 39304265 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Gianfranco Lamberti, MD

  Azienda Unita Sanitaria Locale di Piacenza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianfranco Lamberti, MD

CONTACT

+39 0523 404656; g.lamberti2@ausl.pc.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-07

Locations

IT (1)