Action Observation Training for Upper Limb Recovery in Patients With Stroke
NCT ID: NCT04604171
Last Updated: 2020-10-27
Study Results
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Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2020-05-01
2020-07-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Action Observation Training
Conventional treatment for 60 mins plus Action Observation Training for 30 mins
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).
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.
Task Oriented Training
Conventional treatment for 60 mins plus Task Oriented Training for 30 mins
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.
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.
Interventions
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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).
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Azienda USL Toscana Sud Est
OTHER_GOV
Responsible Party
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Mauro Mancuso - Azienda USL Toscana Sud Est
Director of Physical and Rehabilitative Medicine Unit
Principal Investigators
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Mauro Mancuso
Role: PRINCIPAL_INVESTIGATOR
P.O. Misericordia, Azienda USL Toscana Sud Est
Locations
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Mancuso Mauro
Grosseto, , Italy
Countries
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Other Identifiers
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AUSLToscanaSudEst
Identifier Type: -
Identifier Source: org_study_id