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

Motor Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05570838
• Other study ID #: ALC001NR002
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: November 2023
• Source: Neuron, Spain
• Contact: Lerín Calvo
• Phone: 620187457
• Email: alfre_lerin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: July 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Motor Function
• Stroke

Intervention

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
• 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.

Locations

Country	Name	City	State
Spain	Neuron Mercedes	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Neuron, Spain	University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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