Clinical trial NCT04604171: Action Observation Training for Upper Limb Recovery in Patients With Stroke
Official title: Action Observation Training for Upper Limb Recovery in Patients With Stroke: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Sequelae
Lead sponsor: Azienda USL Toscana Sud Est
Sponsor class: OTHER_GOV
First posted: 2020-10-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: sample of 32 patients with stroke, randomly allocated in the experimental group (EG) or in the control group (CG). Sixteen patients were assigned to EG and sixteen to CG.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Both gender
* First ever stroke
* Unilateral cerebral lesion
* Onset of cerebrovascular pathology for a maximum of 30 days
* Age between 18 and 90 years
* Any schooling
* Preserved ability to understand (Token Test score higher than 8)
* Signature of consent by the patient and/or care giver.

Exclusion Criteria:

* Posterior circulation infarction
* Bilateral cerebral lesions
* Subarachnoid hemorrhage
* Severe unilateral spatial negligence (documented by a BIT star cancellation test score below 51)
* Presence of ideo-motor apraxia as documented by a score \< 53 in De Renzi's test
* Cognitive impairment (MMSE score below 23. 8)
* Severe visual impairment (documented by NIHSS field of vision examination)
* Failure of the patient and/or care-giver to sign consent
* Documented Alcohol and/or drug abuse

Primary outcomes:
measure: Fugl-Meyer Assessment Upper Extremity
timeFrame: The first day of treatment - The last day of treatment after four weeks
Secondary outcomes:
measure: Box and Block Test
timeFrame: The first day of treatment - The last day of treatment after four weeks
measure: Functional Independence Measure
timeFrame: The first day of treatment - The last day of treatment after four weeks
measure: Modified Ashworth Scale
timeFrame: The first day of treatment - The last day of treatment after four weeks
Other outcomes:
Locations:
city: Grosseto
country: Italy
facility: Mancuso Mauro
Study officials:
affiliation: P.O. Misericordia, Azienda USL Toscana Sud Est
name: Mauro Mancuso
role: PRINCIPAL_INVESTIGATOR
References: