Robot-aided Therapy in Stroke Patients for Upper Limb Rehabilitation

NCT01658111 | Terminated

• 1 other identifier: MIT02012EEG
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Numerous studies showed that ascertaining the effectiveness of rehabilitative interventions on conditions leading to long-term disability, such as stroke, is a complex task because the outcome depends on many interacting factors. Several studies underline the importance of brain plasticity and its therapeutic potential in neurological disorders. Accredited theories of cortical reorganization after brain lesion endorse the use of early, intensive, repetitive, and context-related exercise as optimal strategies to promote motor relearning and minimize motor deficit. The use of robotic systems in upper limb motor rehabilitation programs has been already demonstrated to provide safe and intensive treatment to subjects with motor impairments due to a neurological injury: several studies showed the advantages of robotic therapy on chronic post-stroke patients, even if no consistent influence on functional abilities was found and evidence of better results providing intensive treatments, both robotic and conventional rehabilitative techniques, was found. Recent development and recent trial in robot-assisted rehabilitation has shown the great potential of robotic devices for delivering repetitive training, thus facilitating a high intensity and a large dose of training during sub-acute and chronic phases of stroke rehabilitation. The proposed project, through a randomized controlled observer-blind multicenter trial is aimed at evaluating the effectiveness of robot-assisted therapy as additional treatment to the standard physical therapy in the early phase after stroke onset and evaluating in conjunction with EEG and EMG recordings the effects of the rehabilitative treatments in a quantitative, measurable way, by providing reliable and objective methods for measuring functional recovery after stroke.

Conditions

Stroke

Keywords

Stroke; Robots; EEG; EMG

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Fugl-Meyer Scale at 28 weeks.

  at inclusion, week 4 and week 28

• Change from Baseline in Box and Block Test at 28 weeks.

  at inclusion, week 4 and week 28.

Secondary Outcomes (1)

• Change from Baseline in Modified Ashworth Scale at 28 weeks.

  at inclusion, week 4 and week 28.

Other Outcomes (1)

• Change from Baseline in Frenchay Arm Test at 28 weeks.

  at inclusion, week 4 and week 28.

Study Arms (2)

Traditional physiotherapy

ACTIVE COMPARATOR

Each subject will receive 4 weeks of traditional upper limb rehabilitation treatment (20 sessions, 5 days a week for 4 weeks).

Procedure: Traditional physiotherapy

Robot Group

EXPERIMENTAL

Each subject will be asked to perform five sessions per week goal-directed, planar reaching tasks, which emphasizes shoulder and elbow movements, moving from the centre target to each of 8 peripheral targets equally spaced on a 0.14 m radius circumference around a centre target using the InMotion2 (IM2) system (20 sessions- 5 days a week for 4 weeks).

Device: Robot Group

Interventions

Robot Group DEVICE

The MIT-MANUS/InMotion2 (Interactive Motion Technologies, Inc., Watertown, MA, USA) system has two translational degrees of freedom (dof): shoulder abduction-adduction (ab-ad), elbow flexion-extension (flexext). The robotic system supports the execution of reaching movements in the horizontal plane through an assist as needed control strategy. The robot can guide the movement of the upper limb of the patients and record end-effector physical quantities such as the position, velocity, and applied forces. The device is designed to have a low intrinsic end-point impedance (i.e., be back-drivable to easily carry the weight of the patient's arm, to execute movements without constraint and offer minimal resistance. A 3-dof force transducer is placed at the robots end-effector, as well.

Also known as: MIT-MANUS/InMotion2

Robot Group

Traditional physiotherapy PROCEDURE

Active or passive exercises.

Also known as: FKT

Traditional physiotherapy

Eligibility Criteria

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

You may qualify if:

• first acute event of cerebrovascular stroke
• unilateral paresis,
• ability to understand and follow simple instructions,
• ability to remain in a sitting posture, even through seat belts for trunk fixation.

You may not qualify if:

• bilateral impairment,
• severe sensory deficits in the paretic upper limb,
• cognitive impairment or behavioral dysfunction that would influence the ability to comprehend or perform the experiment,
• refusal or inability to provide informed consent
• other current severe medical problems.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (2)

IRCCS San Raffaele Roma

Roma, 00161, Italy

Location

Auxilium Viate Volterra

Volterra, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michela Goffredo, BME

  IRCCS San Raffaele Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: August 6, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2014
• Last Updated: October 3, 2022

Record last verified: 2012-08

Locations

IT (2)