NCT04604171

Action Observation Training for Upper Limb Recovery in Patients With Stroke

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Azienda USL Toscana Sud Est · Other Government
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stroke Sequelae

Interventions

Type	Name	Description
BEHAVIORAL	Action Observation Training	Action Observation Training (AOT) is composed, according to Franceschini et al. (2012), by 20 different videos of daily activities (actions) carried out with the upper limbs. Patients underwent only one task per day for 20 sessions, starting from the easiest. Each action (unimanual or bimanual) is observed from a first-person perspective. Actors in the videos are young non-disabled people, either men or women. Patients are asked to carefully observe the videos, in order to prepare themselves to imitate the presented actions, while the therapist consistently holds the patient's attention with verbal feedback. At the end of each sequence, the therapist prompts the patient to perform the same movement with the paretic upper limb over a time period of 2 minutes, providing verbal instructions or help, if needed. Each session lasts about 30 minutes (3 min of sequence observation and 2 min of action performance for 3 motor sequences repeated twice).
BEHAVIORAL	Task Oriented Training	In Task Oriented Training patients performed functional activities with the upper limbs, using the same objects for AOT, in both unimanual and bimanual modalities, without watching the video beforehand. The therapist just provided for verbal instructions and feedback, avoiding demonstrative or imitative indications. The therapist could passively support the movement if patients were completely unable to perform the actions. When necessary, the therapists could also actively facilitate the upper limb movement if patients were unable to correctly perform the actions. Based on the patient's level of motor ability and progress, the levels of movement and task difficulty could be adjusted accordingly. Patients underwent one task per day for 20 sessions. Each session lasted about 30 minutes.
BEHAVIORAL	Conventional Treatment	Conventional treatment consists of a range of different patient-tailored interventions, selected by the therapist on the basis of the functional level of the patient. Treatment sessions include training for transfers, mobility, walking up and down steps, balance tasks and tailored functional tasks for the upper limbs (unimanual and bimanual). Moreover, it is also provided for joint and soft tissue mobilization, specific sensory stimulation, exercises to increase strength, both for lower and upper limbs. Each session lasted about 60 minutes.

Timeline

• Start date: 2020-05-01
• Primary completion: 2020-06-30
• Completion: 2020-07-31
• First posted: 2020-10-27
• Last updated: 2020-10-27

Locations

1 site across 1 country: Italy