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

Effects of Robotic Assisted Therapy and Functional Electrical Stimulation on Upper Limb Motor Function in Subacute Stroke Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Motor Function
• Intervention / Treatment: Device: Functional Electrical Stimulation; Device: Hand Robotic-Assisted Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lerín Calvo; Phone Number: 620187457; Email: alfre_lerin@hotmail.com

Study Locations

• Spain
  • Madrid, Spain, 28022
    • Neuron Mercedes
    • Contact: Mónica Grifol Domingo, PT; Phone Number: 679664850; Email: mgrifol@neuronrehab.es
    • Sub-Investigator: Mónica Grifol Domingo, PT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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; Other Names: FESIA grasp; 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.; Other Names: AMADEO
Active Comparator: 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	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.; Other Names: AMADEO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manual grip strength	strength is the ability of a muscle or group of muscles to generate tension during maximum dynamic or static effort in relation to the demands placed upon it. In this way, the capacity of the flexor muscles of wrist and finguers will be measured using a manual dynamometer	Change from Baseline in manual grip strength at 6 weeks
Pinch strength	strength is the ability of a muscle or group of muscles to generate tension during maximum dynamic or static effort in relation to the demands placed upon it. In this way, the capacity of the flexor muscles of finguers will be measured using a pinch dynamometer	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)	multidimensional phenomenon composed of 8 domains: emotional well-being, physical well-being, material well-being, self-determination, interpersonal relationships, social inclusion, personal development and individual rights. CAVIDACE questionnaire will be used to asses quality of life.The scale score ranges from 0 to 120, with higher scores corresponding to a higher quality of life.	Change from Baseline in quality of life at 6 weeks 3 months and 6 months
Functional Independence	Functional independence refers to the person's ability to carry out functional activities of daily living without the assistance of others. The FIM-FAM test will be used to asses the functional independence in this population	Change from Baseline in functional independence at 6 weeks

Collaborators and Investigators

• Sponsor: Neuron, Spain
• Collaborators: University of Castilla-La Mancha

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Upper limb; Hand; Motor function; Functional Electrical Stimulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: ALC001NR002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan for sharing IPD with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No