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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04559724
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	IRCCS San Raffaele Roma
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sanaz Pournajaf, Dr.Marco Franceschini, Prof.
Principal Investigator Affiliation	IRCCS San Raffaele PisanaIRCCS San Raffaele Pisana
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Stroke, Brain Injuries, Traumatic, Brain Tumor Benign

Additional Details

The primary objective of this interventional longitudinal pilot study is to investigate the feasibility of using an over-ground wearable robotic system (Indego) for gait rehabilitation of people with PH associated with the traditional rehabilitation. Secondary objectives of the study are:

- To explore the clinical effects of the treatment; - To evaluate the feasibility of implementing this system in clinical practice from experienced therapists (Indego Specialists)' point of view.

Two Sub-Studies (SS) will be conducted with the following aims: 1. Kinematic gait analysis (in subjects able to walk) associated with surface electromyography (sEMG) of 4 muscle groups of the lower limbs in order to evaluate changes in the gait pattern and muscle activity following gait rehabilitation through an over-ground wearable exoskeleton system; 2. Electroencephalographic (EEG) analysis in order to: identify prognostic factors for walking recovery; investigate the effect of the treatment on functional connectivity. 30 subjects with PH and walking impairment who meet the research project inclusion and exclusion criteria will be recruited for this study. Patients will be evaluated at T0 and at T1. Demographic (gender, date of birth, height, weight, education, dominant side, work activity, presence of the social network, presence of architectural barriers at home) and clinical data (comorbidity, drug therapy, blood pressure, the cardiac frequency at rest, date of last acute event, number of previous neurological events, location of acute events) of all participants will be recorded at T0. In the case of Sub-Studies, 10 patients (able to walk fo 4 meters without aids but with supervision) for SS1 and 5 patients for SS2 following the first-ever monofocal cerebrovascular acute event will be recruited. These subjects will be assessed both clinically and instrumentally (SS1: through the gait analysis and sEMG; SS2: through the EEG) at T0 and T1.

Arms & Interventions

Arms

Experimental: Indego-Assisted Gait Rehabilitation

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.

Interventions

Device: - Indego Therapy

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.

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International Sites

IRCCS San Raffaele Pisana, Roma, Italy

Status

Address

IRCCS San Raffaele Pisana

Roma, , 00163

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