Gait Training Through a Novel Over-ground Wearable Robotic System in People with Pyramidal Hemisyndromes

NCT04559724 | Active Not Recruiting DMC

• 1 other identifier: RP 20/13
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Over-ground exoskeletons for gait rehabilitation are studied enough in people suffering spinal cord injury, and its clinical use is escalating in the industrialized countries. Nevertheless, studies on gait rehabilitation through exoskeletons in subjects with Pyramidal Hemisyndrome (PH) are recognized by GRADE as Low Quality of evidence. This interventional longitudinal pilot study is aimed to investigate the feasibility, clinical effects, and compliance (from the experienced therapists (Indego Specialists)' point of view) of using an over-ground wearable robotic system (Indego) for gait rehabilitation of people with PH in the clinical practice. Two substudies will be conducted with the following aims: to explore changes in the gait pattern and muscle activity following Indego-assisted gait rehabilitation through the kinematic gait analysis (in subjects able to walk) associated with surface electromyography (sEMG) of 4 muscle groups of the lower limbs; to identify prognostic factors for walking recovery, investigating also the effect of the treatment on functional connectivity through the electroencephalographic (EEG) analysis. In order to satisfy the study aims, 30 subjects with PH and walking impairment will be recruited and assessed both clinically and instrumentally (in case of substudies) at the beginning (T0) and the end (T1) of the treatment period.

Conditions

Stroke; Brain Injuries, Traumatic; Brain Tumor Benign

Keywords

Gait rehabilitation; Robot-assisted rehabilitation; Walking recovery; Cerebro-vascular disease; Cereberal activity

Outcome Measures

Primary Outcomes (1)

• Changes in 6 Minute Walk Test (6MWT)

  The 6MWT measures the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The minimal detectable change in distance for people with sub-acute stroke is 60.98 meters. The 6MWT is a patient self-paced walk test and assesses the level of functional capacity. Patients are allowed to stop and rest during the test. However, the timer does not stop. If the patient is unable to complete the test, the time is stopped at that moment. The missing time and the reason of the stop are recorded.

  Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).

Secondary Outcomes (8)

• Change in 10 Meter Walk Test (10MWT)

  Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).

• Change in Timed Up And Go (TUG)

  Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).

• Change in Modified Ashworth Scale (MAS)

  Session 1 (treatment onset, T1), and Session 15+2 (end of treatment, T2).

• Change in Trunk Control Test (TCT)

  Session 1 (treatment onset, T1), and Session 15+2 (end of treatment, T2).

• Change in Functional Ambulation Classification (FAC)

  Session 1 (treatment onset, T1), and Session 15+2 (end of treatment, T2).

Other Outcomes (2)

• Gait Analysis (GA)

  Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).

• Electroencephalography (EEG)

  Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).

Study Arms (1)

Indego-Assisted Gait Rehabilitation

EXPERIMENTAL

Every session of Indego-assisted gait rehabilitation will last 30 minutes, excluding preparation times (dressing, measurements, and adaptation of the brace to the anthropological measures of the various patients). The Indego program will be set based on the patient's ambulatory abilities, assessed by the Functional Ambulation Classification (FAC): * subjects unable to walk or high-.assistance needed (FAC = 0-2): Motion + program; * Subjects able to walk with mid/mini assistance or with supervision only (FAC = 3-5): Therapy + program. * During the treatment, the program change from Motion + to Therapy + is allowed based on the experts' opinion.

Device: Indego Therapy

Interventions

Indego Therapy DEVICE

Indego Therapy consists of 15 + 2 sessions of Indego - Therapy, each lasting 30 minutes for a maximum of 6 weeks. All the device parameters such as step height (knee and hip), step length, step cycle speed, single and bilateral assistance are customizable. The use of aids during Idego-Therapy is allowed if needed. The Indego specialist should initially be positioned behind the patient, checking the exoskeleton and patient's gait pattern. The supervision of an assistant placed on the patient's healthy side is recommended in the first sessions in order to ensure greater safety to the patient. Constant supervision should be provided by Indego specialist during the whole treatment.

Indego-Assisted Gait Rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single or multiple unilateral Cerebral Stroke
• Mild / moderate Traumatic Brain Injury
• Brain Tumor Benign
• Possibility to keep the upright position for at least 1 minute with good cardiovascular compensation and:
• With double support and supervision;
• With double support without supervision;
• With single support and supervision;
• With single support without supervision;
• With assistance not exceeding 50%;
• With supervision only.

You may not qualify if:

• Severe cognitive impairment or behavioral dysfunction such as not to understand or participate in the whole execution
• Refusal or impossibility to provide informed consent
• Impossibility to wear the robot:
• for serious functional limitations in the coxo-femoral joints and knees;
• marked hyper tone with sudden spasms in flexion;
• Modified Ashworth Scale \> 3;
• weight over 113 Kg;
• height less than 155 cm or higher than 195 cm;
• hip width greater than 46 cm.
• Sever cardio-respiratory co-morbidities.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

IRCCS San Raffaele Pisana

Roma, Roma, 00163, Italy

Location

Related Publications (20)

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  BACKGROUND

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MeSH Terms

Conditions

Stroke; Brain Injuries, Traumatic; Brain Neoplasms

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Sanaz Pournajaf, Dr.

  IRCCS San Raffaele Pisana

  PRINCIPAL INVESTIGATOR

• Marco Franceschini, Prof.

  IRCCS San Raffaele Pisana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 23, 2020
• Study Start: September 1, 2020
• Primary Completion: May 21, 2025
• Study Completion: December 30, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)