Robot Walking Rehabilitation in Stroke Patients

NCT01678547 | Terminated

• 1 other identifier: RP 19/12
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

Stroke are the main causes of motor disability among adults and are expected to impose an increasing social and economic burden for our Country. The impact of stroke on patients is enormous, with negative ramifications on the persons participation in social, vocational, and recreational activities. It is the primary cause of long-term disability in these countries. At the present stage, it is well known that control of balance during upright standing depends upon the central integration of afferent information from vestibular, somatosensory (proprioceptive, tactile), and visual systems, which constitute a multilink neural network for the control of neck, hip, and ankle joints. More recently, it has been studied at the level of cerebral cortex; vestibular inputs would reach face/neck representation of primary somatosensory cortex and would be then integrated with visual and somatosensory inputs in intraparietal, posterior end of the insula and medial superior temporal cortices. Remarkably, balance impairment and the associated risk of falling represent one of the most prominent and potentially disabling features in stroke subjects. The specific aims of this project are: to verify whether the robotics lower limb treatment with body weight support is more effective than the treadmill treatment in the reduction of motor impairment in Stroke patients, and to improve the quality of the gait and the endurance and to analyze possible improvements in terms of physiological biomechanical gait through analysis of spatio-temporal parameters.

Conditions

Stroke; Gait Disorders, Neurologic

Keywords

Stroke; Robot; Treatment; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 6 minuts walking test.

  The 6 minuts walking test as primary outcome assessments will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day \> last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).

  Change from Baseline in gait speed at 6 months follow up.

Secondary Outcomes (5)

• Fugl Meyer (lower limb section)

  Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.

• Borg scale

  Change from Baseline in Borg scale at 6 months follow up.

• Gait Parameters with EMG

  baseline, weekly during intervention, 6 months follow up

• Functional Ambulation Classification

  Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.

• Walk Handicap Scale (WHS)

  Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.

Study Arms (3)

Robot G-EO

EXPERIMENTAL

Each subject will be asked to perform 15 sessions (3 to 5 days a week for 4 up to 5 weeks) consisting of a treatment cycle using the GE-O system device, according to individually tailored exercise scheduling.

Device: Robot-assisted walking

Treadmill Training

ACTIVE COMPARATOR

Each subject will be asked to perform 15 sessions (3 to 5 days a week for 4 up to 5 weeks) consisting of a treatment cycle using the treadmill system device, according to individually tailored exercise scheduling.

Device: Treadmill Training

Ground treatment

ACTIVE COMPARATOR

Ground Control Group (cCG): Each subject will be asked to perform 15 sessions (3 to 5 days a week for 4 up to 5 weeks) of traditional lower limb physiotherapy treatment.

Other: Ground treatment

Interventions

Robot-assisted walking DEVICE

The practice will included an add-on robot-assisted walking therapy at variable speeds for 40 min with a partial body weight support (BWS). All participants will start with 30-40% BWS and an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h and the BWS % will be decreased.

Also known as: G-EO System (Reha Technology AG Switzerland)

Robot G-EO

Treadmill Training DEVICE

The practice will included an add-on treadmill walking therapy at variable speeds for 40 min with a partial body weight support (BWS). All participants will start with 30-40% BWS and an initial comfortable treadmill speed and the speed will be increased to a range of 1,0 to 2.5 km/h and the BWS % will be decreased.

Also known as: Gait Trainer 3 (Biodex Medical Systems New York)

Treadmill Training

Ground treatment OTHER

The practice will included ground walking therapy s for 40 min with therapist support.

Also known as: Physiotherapy treatment.

Ground treatment

Eligibility Criteria

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

You may qualify if:

• between the ages of 18-95 years;
• able to walk 25 feet unassisted or with assistance
• truck control
• first acute event of cerebrovascular stroke
• unilateral paresis,
• ability to understand and follow simple instructions
• ability to walk without assistance prior to stroke
• endurance sufficient to stand at least 20 minutes unassisted per patient report.

You may not qualify if:

• unable to understand instructions required by the study (Informed Consent Test of Comprehension).
• medical or neurological comorbidities that might contribute to significant gait dysfunction.
• uncontrolled hypertension \> 190/110 mmHg.
• significant symptoms of orthostasis when standing up.
• circulatory problems, history of vascular claudication or significant (+3) pitting edema.
• lower extremity injuries or joint problems (hip or leg) that limit range of motion or function, or cause pain with movement
• bilateral impairment,
• severe sensory deficits in the paretic upper limb,
• cognitive impairment or behavioral dysfunction that would influence the ability to comprehend or participate in the study.
• Women who are pregnant and/or lactating.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (2)

San Raffaele Cassino

Cassino, Italy

Location

IRCCS San Raffaele Roma

Rome, 00166, Italy

Location

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michela Goffredo, BME

  IRCCS San Raffaele Rome Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 5, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2015
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

IT (2)