Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05570838 |
Other study ID # |
ALC001NR002 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.