Stroke SequelaeNCT04604171
Action Observation Training for Upper Limb Recovery in Patients With Stroke
A study testing Action Observation Training, Task Oriented Training and Conventional Treatment in people with Stroke Sequelae, run by Azienda USL Toscana Sud Est at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke Sequelae
- What is being tested?
- Action Observation Training, Task Oriented Training and Conventional Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2020to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Action Observation Training for Upper Limb Recovery in Patients With Stroke: a Randomized Controlled Study
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.
Read the 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
- Being tested
- Action Observation Training, Task Oriented Training, Conventional Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation TrainingBehavioural
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 TrainingBehavioural
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 TreatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Action Observation Training | Experimental | Conventional treatment for 60 mins plus Action Observation Training for 30 mins Receives: Behavioral: Action Observation Training; Behavioral: Conventional Treatment |
| Task Oriented Training | Active comparator | Conventional treatment for 60 mins plus Task Oriented Training for 30 mins Receives: Behavioral: Task Oriented Training; Behavioral: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment Upper Extremity
the scale, which has good psychometric properties, is a quantitative measure of motor impairment in post stroke hemiplegic patients. Items are scored on a 3-point ordinal scale (0 = cannot perform; 1 = partially performs; 2 = fully performs). The upper limb section (FMA-UE) includes shoulder, elbow, wrist flexion and extension cooperative movement, wrist joint stability, coordination ability, and speed of small joint movement. The four domains assessed include motor function, sensation, passive joint motion, and joint pain. For this study we only used the motor function subscale. The total score of FMA-UE motor function range from 0 to 66.
Measured: The first day of treatment - The last day of treatment after four weeks
Secondary outcomes (3)
Box and Block Test
the BBT assesses unilateral gross manual dexterity in stroke subjects. It requests patients to seat at a table, facing a rectangular box that is divided into two sections of equal dimensions. One of the two compartments contains one hundred and fifty coloured, wooden cubes, measuring 2.5 cm in width. The subject is instructed to move as many blocks as possible, one at a time, from one section to the other for a period of 60 seconds. The final score is computed by counting the number of blocks moved during the one-minute trial period. Healthy adults aged 20 and up have been found to move around 75 cubes ± 9.1 within one minute, without any significant difference between the dominant and non-dominant hand. Its reliability and validity are satisfactory in stroke patients.
Measured: The first day of treatment - The last day of treatment after four weeks
Functional Independence Measure
the purpose of this scale is to assess the patients physical, psychological and social functions. It includes self-care, eating, grooming, bathing, dressing, toileting, swallowing, sphincter control, mobility, transfer and locomotion. The scale is composed of 18 items: 13 items are in physical domains and 5 items are related to cognition. Motor items measure self-care, sphincter control, locomotion and transfers. Cognitive items evaluate subject's communication abilities and social cognition. Based on the level of independence, each item is scored from 1 to 7. The lower score indicates total dependence and the higher represents complete independence. Total score ranges from 18 to 126. The total FIM score indicates the level of disability and the burden of their carer. The FIM has good reliability, validity, and responsiveness.
Measured: The first day of treatment - The last day of treatment after four weeks
Modified Ashworth Scale
this is a six-point ordinal scale for grading the resistance encountered during passive muscle stretching. The Scale assesses spasticity as follows: 0 = normal muscle tone; 1 = slight increase in muscle tone at the end of the range of motion (ROM) when limb is moved; 1+ = slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2 = more marked increase in muscle tone, but limb easily flexed; 3 = considerable increase in muscle tone; and 4 = limb rigid in flexion or extension.
Measured: The first day of treatment - The last day of treatment after four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 May 2020
- Primary completion30 Jun 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Toscana Sud Est
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mauro Mancuso - Azienda USL Toscana Sud Est, Azienda USL Toscana Sud Est
- Investigators
- Mauro Mancuso, Principal investigator, P.O. Misericordia, Azienda USL Toscana Sud Est
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604171
- Sponsor's protocol ID
- AUSLToscanaSudEst
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action Observation Training for Upper Limb Recovery in Patients With Stroke: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04604171
- Acronym / sponsor ID
- AUSLToscanaSudEst
- Conditions
- Stroke Sequelae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Azienda USL Toscana Sud EstOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Action Observation Training | Experimental | Behavioral: Action Observation Training, Behavioral: Conventional TreatmentConventional treatment for 60 mins plus Action Observation Training for 30 mins |
| Task Oriented Training | Active comparator | Behavioral: Task Oriented Training, Behavioral: Conventional TreatmentConventional treatment for 60 mins plus Task Oriented Training for 30 mins |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Both gender
- First ever stroke
- Unilateral cerebral lesion
- Onset of cerebrovascular pathology for a maximum of 30 days
- Age between 18 and 90 years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Observation TrainingAction 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). | Behavioural | Action Observation Training |
| Task Oriented TrainingIn 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. | Behavioural | Task Oriented Training |
| Conventional TreatmentConventional 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. | Behavioural | Action Observation Training, Task Oriented Training |
Primary outcome
Fugl-Meyer Assessment Upper Extremity
Time frame: The first day of treatment - The last day of treatment after four weeks
the scale, which has good psychometric properties, is a quantitative measure of motor impairment in post stroke hemiplegic patients. Items are scored on a 3-point ordinal scale (0 = cannot perform; 1 = partially performs; 2 = fully performs). The upper limb section (FMA-UE) includes shoulder, elbow, wrist flexion and extension cooperative movement, wrist joint stability, coordination ability, and speed of small joint movement. The four domains assessed include motor function, sensation, passive joint motion, and joint pain. For this study we only used the motor function subscale. The total score of FMA-UE motor function range from 0 to 66.
3 secondary outcomes
Box and Block Test
Time frame: The first day of treatment - The last day of treatment after four weeks
Functional Independence Measure
Time frame: The first day of treatment - The last day of treatment after four weeks
Modified Ashworth Scale
Time frame: The first day of treatment - The last day of treatment after four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro Mancuso principal investigator
P.O. Misericordia, Azienda USL Toscana Sud Est
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation Training, Task Oriented Training and Conventional Treatment in people with Stroke Sequelae, run by Azienda USL Toscana Sud Est at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment Upper Extremity (time frame: The first day of treatment - The last day of treatment after four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.