RAT and FES Effects on Upper Limb Motor Function in Subacute Stroke Patients

NCT05570838 | Terminated

• 1 other identifier: ALC001NR002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is one of the leading causes of mortality worldwide and is the leading cause of disability. Currently, a large number of novel treatments are emerging with the aim of recovering the highest functionality and quality of life for these patients, including Robot Assisted Therapy (RAT) and functional electrostimulation (FES). The aim of this study is to observe the effect of FES with respect to conventional treatment and RAT for the improvement of motor function of the upper limb. For this purpose, a clinical trial will be carried out in which participants will be divided into two groups, a first group that will receive conventional treatment together with RAT and FES and a second group that will only receive conventional treatment combined with RAT. The hypothesis of the research group is that the group receiving conventional treatment together with RAT and FES will obtain greater improvements in motor function.

Conditions

Motor Function

Keywords

Functional Electrical Stimulation; Stroke; Motor function; Upper limb; Hand

Outcome Measures

Primary Outcomes (1)

• Upper limb motor function

  the ability to learn or demonstrate the ability to acquire, maintain, modify and control voluntary postures and movement patterns with a goal framed motor behaviour. It will be measured wit the Action Research Arm Test (ARAT). This test asses the motor dexterity of the patient by 4 subtest based on functional movements (grasping, holding, clamping and gross movement

  Change from Baseline in upper limb motor function at 6 weeks

Secondary Outcomes (4)

• Manual grip strength

  Change from Baseline in manual grip strength at 6 weeks

• Pinch strength

  Change from Baseline in pinch strength at 6 weeks

• Quality of life measured with CAVIDACE questionnaire (Evaluación de la Calidad de Vida de personas con Daño Cerebral)

  Change from Baseline in quality of life at 6 weeks 3 months and 6 months

• Functional Independence

  Change from Baseline in functional independence at 6 weeks

Study Arms (2)

FES + conventional treatment

EXPERIMENTAL

60 minutes per session, 5 sessions per week with 30 minutes of task-specific training using Functional Electrical Stimulation applyed by Fesia Grasp device and 30 minutes of Robotic-Assisted Therapy using Amadeo robot for hand rehabilitation

Device: Functional Electrical Stimulation; Device: Hand Robotic-Assisted Therapy

Conventional treatment

ACTIVE COMPARATOR

60 minutes per session, 5 sessions per week with 30 minutes of task-specific training and 30 minutes of Robotic-Assisted Therapy using Amadeo robot for hand rehabilitation

Device: Hand Robotic-Assisted Therapy

Interventions

Functional Electrical Stimulation DEVICE

Functional Electrical Stimulation consist on applying a current on the damaged muscles when the patient is doing a task that requires them. 120 repetitions will be made on the 6 first sessions and 180 repetitions will be done after the sixth session

Also known as: FESIA grasp

FES + conventional treatment

Hand Robotic-Assisted Therapy DEVICE

The hand Robotic-Assisted Therapy will be applyed using the AMADEO robot for hand rehabilitation by Tyromotion. The protocol that will be used consists on 200 repetitions on the active-assisted mode with flexion and extension of all the finguers and 50 repetitions on the active mode.

Also known as: AMADEO

Conventional treatment; FES + conventional treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acquired brain damage (caused by stroke or TBI) with less than one year of evolution.
• Upper limb impairment and a score on the FMA-UE scale \>11 and \<55.
• To present a stable clinical condition.
• Have no other neurological or disabling pathology or previous dependence.
• Agree to participate in the study and sign the informed consent form.

You may not qualify if:

• Having suffered epileptic seizures within 6 months prior to the start of the study.
• Pain \>5 on the Visual Analogue Scale (VAS) or the Verbal Numerical Scale (VNS).
• Score \<21 points on the Mini-Mental State Examination scale.
• Failure to sign the informed consent form.
• Occurrence of adverse events during or after the sessions.

Sponsors & Collaborators

• Neuron, Spain: lead
• University of Castilla-La Mancha: collaborator

Study Sites (1)

Neuron Mercedes

Madrid, Madrid, 28022, Spain

Location

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: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 7, 2022
• Study Start: May 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)