Clinical trial NCT05570838: RAT and FES Effects on Upper Limb Motor Function in Subacute Stroke Patients
Official title: Effects of Robotic Assisted Therapy and Functional Electrical Stimulation on Upper Limb Motor Function in Subacute Stroke Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Motor Function
Keywords: Functional Electrical Stimulation
Stroke
Motor function
Upper limb
Hand
Lead sponsor: Neuron, Spain
Sponsor class: OTHER
Collaborators: name: University of Castilla-La Mancha
First posted: 2022-10-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Upper limb motor function
timeFrame: Change from Baseline in upper limb motor function at 6 weeks
Secondary outcomes:
measure: Manual grip strength
timeFrame: Change from Baseline in manual grip strength at 6 weeks
measure: Pinch strength
timeFrame: Change from Baseline in pinch strength at 6 weeks
measure: Quality of life measured with CAVIDACE questionnaire (Evaluación de la Calidad de Vida de personas con Daño Cerebral)
timeFrame: Change from Baseline in quality of life at 6 weeks 3 months and 6 months
measure: Functional Independence
timeFrame: Change from Baseline in functional independence at 6 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Neuron Mercedes
Study officials:
References: