Improving Hand Motor Function After Stroke: Role of Robotics

Two recent randomized clinical trials reported a significant contribute of Amadeo toward the recovery of hand motor function in acute stroke patients in association with physiotherapy and/or occupational therapy. However, no data are available in patients with chronic stroke, and the neurophysiological mechanisms underlying such clinical improvement need to be elucidated. Given that robotic devices harness brain plasticity to foster motor function recovery, a deeper understanding of the neurophysiological bases of Amadeo training could help clinician to realize patient-tailored rehabilitative training based brain plasticity knowledge. We planned a pilot randomized-controlled observer trial aimed at evaluating the effects of intensive robot-assisted hand therapy compared with intensive occupational therapy in chronic phase after stroke. We estimated that 40 patients per group will be required to demonstrate a greater effect of Amadeo as compared to occupational therapy, with an effect size of 0.5. Twenty chronic stroke patients (at their first-ever stroke) will be enrolled and randomized into two groups. The experimental group will be provided with Amadeo training. The Control group will be provided with occupational therapy executed by a trained physiotherapist.

Study Overview

• Status: Completed
• Conditions: It is Possible That Amadeo Will Guarantee a Greater Clinical Improvement as Compared to an Occupational Therapy Thanks to the Strengthening of Brain Plasticity
• Intervention / Treatment: Device: Amadeo Training

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Messina, Italy, 98124
    • IRCCS Centro Neurolesi "Bonino-Pulejo"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• chronic stroke patients at their first-ever supratentorial stroke

Exclusion Criteria:

• presence of severe medical, psychiatric and cognitive abnormalities as to interfere with the treatment.
• controindications to the device use.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amadeo training; All participants will receive 40 sessions of treatment (45-minute) for 8 consecutive weeks (5 days/week). The robotic exercises will be carried in passive modality (15 minutes), passive/plus (15 minutes), assisted modality (15 minutes).	Device: Amadeo Training; To understand the cortical modifications related to movement preparation and execution after robot-assisted training we will study the EEG modifications of cortical activity using time-frequency event-related EEG and task-related coherence (TRCoh). Friedman ANOVA with post-hoc t-test (corrected for multiple comparisons) will be used to assess the significance of training-induced changes in the two groups.
Active Comparator: occupational therapy; All participants will receive 40 sessions of treatment (45-minute) for 8 consecutive weeks (5 days/week). The control group will receive the same amount of training by physiotherapist skilled in occupational tharapy.	Device: Amadeo Training; To understand the cortical modifications related to movement preparation and execution after robot-assisted training we will study the EEG modifications of cortical activity using time-frequency event-related EEG and task-related coherence (TRCoh). Friedman ANOVA with post-hoc t-test (corrected for multiple comparisons) will be used to assess the significance of training-induced changes in the two groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nine hole peg test	Administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. The board should be placed at the client's midline, with the container holding the pegs oriented towards the hand being tested. Only the hand being evaluated should perform the test. Hand not being evaluated is permitted to hold the edge of the board in order to provide stability. Scores are based on the time taken to complete the test activity, recorded in seconds. Alternative scoring - the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second. Stopwatch should be started from the moment the participant touches the first peg until the moment the last peg hits the container.	by 5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cortical modifications related to movement preparation and execution after robot-assisted training	Assessment of EEG modifications of cortical activity using time-frequency event-related EEG and task-related coherence (TRCoh).	about 30 minutes

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Investigators: Study Chair: Placido Bramanti, IRCCS Neurolesi

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): February 20, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: September 22, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 44/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No