Action Observation Training for Upper Limb Recovery in Patients With Stroke

NCT04604171 | Completed

• 1 other identifier: AUSLToscanaSudEst
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Sequelae

Outcome Measures

Primary Outcomes (1)

• 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.

  The first day of treatment - The last day of treatment after four weeks

Secondary Outcomes (3)

• Box and Block Test

  The first day of treatment - The last day of treatment after four weeks

• Functional Independence Measure

  The first day of treatment - The last day of treatment after four weeks

• Modified Ashworth Scale

  The first day of treatment - The last day of treatment after four weeks

Study Arms (2)

Action Observation Training

EXPERIMENTAL

Conventional treatment for 60 mins plus Action Observation Training for 30 mins

Behavioral: Action Observation Training; Behavioral: Conventional Treatment

Task Oriented Training

ACTIVE COMPARATOR

Conventional treatment for 60 mins plus Task Oriented Training for 30 mins

Behavioral: Task Oriented Training; Behavioral: Conventional Treatment

Interventions

Action Observation Training BEHAVIORAL

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).

Action Observation Training

Task Oriented Training BEHAVIORAL

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.

Task Oriented Training

Conventional Treatment BEHAVIORAL

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.

Action Observation Training; Task Oriented Training

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda USL Toscana Sud Est: lead

Study Sites (1)

Mancuso Mauro

Grosseto, 58100, Italy

Location

Study Officials

• Mauro Mancuso

  P.O. Misericordia, Azienda USL Toscana Sud Est

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Physical and Rehabilitative Medicine Unit

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 27, 2020
• Study Start: May 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: July 31, 2020
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)