Improving Hand Motor Function After Stroke: Role of Robotics

NCT ID: NCT03292276

Last Updated: 2018-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2018-03-31

Brief Summary

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Amadeo Training

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Amadeo Training

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

Sponsor Role: lead

Responsible Party

Rocco Salvatore Calabrò

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Placido Bramanti

Role: STUDY_CHAIR

IRCCS Neurolesi

Locations

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, , Italy

Countries

Italy

Other Identifiers

44/2016

Identifier Type: -

Identifier Source: org_study_id