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

NCT ID: NCT05570838

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-07-01

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.

Detailed Description

On the first day, participants will be asked to sign the informed consent form and the inclusion and exclusion criteria will be reconfirmed. Subsequently, manual grip strength, terminal opposition grip strength, subterminal opposition grip strength, subterminal opposition grip strength, subterminal-lateral grip strength and tridigital grip strength will be assessed using a JAMAR dynamometer. After this, the CAVIDACE quality of life scale and the FIM-FAM functional independence scale will be completed. Finally, motor function assessment will be carried out with the ARAT.

After the end of the treatment, the reassessment will be carried out and the initial assessments will be repeated. Subsequently, study participants will be followed up telematically, assessing quality of life using the CAVIDACE scale. Follow-up will be carried out 3 and 6 months after the end of treatment.

The data collected will be stored in a database created for this purpose with the Microsoft Access programme. Subsequently, they will be analysed using the SPSS/PC statistical programme. An exploratory analysis of all the information collected will be carried out for descriptive purposes; qualitative variables will be analysed using percentages, while quantitative variables will be analysed using mean and standard deviation. In both cases, the confidence intervals will be 95%.

After verifying whether the distribution of the data is normal or not, the hypothesis tests indicated in each case will be applied (χ2, Student's t, ANOVA, etc.). A significance level of 0.05 will be used for hypothesis testing. All analyses will be performed on an intention-to-treat basis.

Conditions

Motor Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

FES + conventional treatment

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

Group Type: EXPERIMENTAL

Functional Electrical Stimulation

Intervention Type: 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

Hand Robotic-Assisted Therapy

Intervention Type: 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.

Conventional treatment

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

Group Type: ACTIVE_COMPARATOR

Hand Robotic-Assisted Therapy

Intervention Type: 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.

Interventions

Functional Electrical Stimulation

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

Intervention Type: DEVICE

Hand Robotic-Assisted Therapy

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.

Intervention Type: DEVICE

Other Intervention Names

FESIA grasp; AMADEO

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Castilla-La Mancha

OTHER

Sponsor Role: collaborator

Neuron, Spain

OTHER

Sponsor Role: lead

Responsible Party

Alfredo Lerín Calvo

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Neuron Mercedes

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

ALC001NR002

Identifier Type: -

Identifier Source: org_study_id