Action Observation Training for Upper Limb Recovery in Patients With Stroke

Stroke Sequelae Clinical Trial

Official title: Action Observation Training for Upper Limb Recovery in Patients With Stroke: a Randomized Controlled Study

Status Completed

Clinical Trial Summary

Background: Due to the complexity of the interventions in recovering the upper limb, at the moment there is a lack of evidence about the efficacy of rehabilitative interventions. Action Observation Training (AOT) constitutes a promising rehabilitative method to improve upper limb motor recovery in stroke patients.

Objective: The aim of the present study was to evaluate the effect of AOT both on upper limb recovery and on functional outcome when compared to patients treated with the task oriented training (TOT). Both treatments were added to traditional rehabilitative treatment.

Clinical Trial Description

Participants Sample of 32 patients with stroke, randomly allocated in the experimental group (EG) or in the control group (CG).

Each participant underwent clinical assessments at Day 0 (the first day of treatment) and at the T1 time (last day of treatment after four weeks).

All assessment tools were performed by trained researchers not involved in the treatment administration.

All subjects underwent rehabilitative treatment for 4 consecutive weeks, 5 days per week. Each session consisted of 60 minutes of conventional treatment per day and, in addition, thirty minutes of Action Observation Training for the experimental group, or thirty minutes of Task Oriented Training for the control group.

Clinical scales

• Canadian Neurological Scale

• Bamford Classification

• Fugl-Meyer Assessment Upper Extremity

• Box and Block Test

• Functional Independence Measure

• Modified Ashworth Scale

Treatments adopted in the study:

• Action Observation Training

• Task Oriented Training

• Conventional Treatment

Statistical Analysis Preliminary descriptive analysis to check the normal distribution of data using the Kolmogorov-Smirnov test.

Parametric or non-parametric statistics depending on variables distribution. Student's T-test and Chi-square analyses to assess the homogeneity of the sample according to demographic and clinical data as appropriate.

Determination of statistical significance of intra-group improvement from admission to discharge, pre-treatment and post-treatment scores using Wilcoxon signed-rank test for MAS, FMA-UE motor function, and BBT of the paretic arm, using t-test for FIM scores.

Calculation of rehabilitative gain, as the difference between the post-treatment score and the baseline, divided by the difference between the maximum scoring of the test and the score obtained by the patient at the baseline. This index indicates the percentage of the improvement compared to the maximum obtainable improvement.

The alpha level for significance was set at p < 0.05 for first level of analysis.

Software for statistical analysis: Statistical Package for the Social Sciences (SPSS) software, version 20.0. ;

Related Conditions & MeSH terms

• Stroke
• Stroke Sequelae

• NCT number: NCT04604171
• Study type: Interventional
• Source: Azienda USL Toscana Sud Est
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Completion date: July 31, 2020