Clinical trial NCT04559724: Gait Training Through a Novel Over-ground Wearable Robotic System in People with Pyramidal Hemisyndromes
Official title: Longitudinal Pilot Study on the Feasibility of Integrating Gait Training Through a Novel Over-ground Wearable Robotic System to Traditional Rehabilitation in People with Pyramidal Hemisyndromes.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Brain Injuries, Traumatic
Brain Tumor Benign
Keywords: Gait rehabilitation
Robot-assisted rehabilitation
Walking recovery
Cerebro-vascular disease
Cereberal activity
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Changes in 6 Minute Walk Test (6MWT)
timeFrame: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).
Secondary outcomes:
measure: Change in 10 Meter Walk Test (10MWT)
timeFrame: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).
measure: Change in Timed Up And Go (TUG)
timeFrame: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).
measure: Change in Modified Ashworth Scale (MAS)
timeFrame: Session 1 (treatment onset, T1), and Session 15+2 (end of treatment, T2).
measure: Change in Trunk Control Test (TCT)
timeFrame: Session 1 (treatment onset, T1), and Session 15+2 (end of treatment, T2).
measure: Change in Functional Ambulation Classification (FAC)
timeFrame: Session 1 (treatment onset, T1), and Session 15+2 (end of treatment, T2).
measure: Change in Barthel Index (BI)
timeFrame: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).
measure: Change in Walking Handicap Scale (WHS)
timeFrame: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).
measure: Change in Motricity Index (MI)
timeFrame: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).
Other outcomes:
measure: Gait Analysis (GA)
timeFrame: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).
measure: Electroencephalography (EEG)
timeFrame: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).
Locations:
city: Roma
country: Italy
facility: IRCCS San Raffaele Pisana
Study officials:
affiliation: IRCCS San Raffaele Pisana
name: Sanaz Pournajaf, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS San Raffaele Pisana
name: Marco Franceschini, Prof.
role: STUDY_CHAIR
References:
citation: Lord SE, McPherson K, McNaughton HK, Rochester L, Weatherall M. Community ambulation after stroke: how important and obtainable is it and what measures appear predictive? Arch Phys Med Rehabil. 2004 Feb;85(2):234-9. doi: 10.1016/j.apmr.2003.05.002.
citation: Robinson CA, Shumway-Cook A, Ciol MA, Kartin D. Participation in community walking following stroke: subjective versus objective measures and the impact of personal factors. Phys Ther. 2011 Dec;91(12):1865-76. doi: 10.2522/ptj.20100216. Epub 2011 Oct 14.
citation: Perry J. Analisi del movimento. Elsevier Italia srl, Milano 2005.
citation: Pearson KG. Common principles of motor control in vertebrates and invertebrates. Annu Rev Neurosci. 1993;16:265-97. doi: 10.1146/annurev.ne.16.030193.001405. No abstract available.
citation: Barbeau H, Rossignol S. Recovery of locomotion after chronic spinalization in the adult cat. Brain Res. 1987 May 26;412(1):84-95. doi: 10.1016/0006-8993(87)91442-9.
citation: Dietz V, Zijlstra W, Duysens J. Human neuronal interlimb coordination during split-belt locomotion. Exp Brain Res. 1994;101(3):513-20. doi: 10.1007/BF00227344.
citation: Edgerton VR, Tillakaratne NJ, Bigbee AJ, de Leon RD, Roy RR. Plasticity of the spinal neural circuitry after injury. Annu Rev Neurosci. 2004;27:145-67. doi: 10.1146/annurev.neuro.27.070203.144308.
citation: Richards CL, Malouin F, Bravo G, Dumas F, Wood-Dauphinee S. The role of technology in task-oriented training in persons with subacute stroke: a randomized controlled trial. Neurorehabil Neural Repair. 2004 Dec;18(4):199-211. doi: 10.1177/1545968304269397.
citation: Nichols-Larsen DS, Clark PC, Zeringue A, Greenspan A, Blanton S. Factors influencing stroke survivors' quality of life during subacute recovery. Stroke. 2005 Jul;36(7):1480-4. doi: 10.1161/01.STR.0000170706.13595.4f. Epub 2005 Jun 9.
citation: Franceschini M, Carda S, Agosti M, Antenucci R, Malgrati D, Cisari C; Gruppo Italiano Studio Allevio Carico Ictus. Walking after stroke: what does treadmill training with body weight support add to overground gait training in patients early after stroke?: a single-blind, randomized, controlled trial. Stroke. 2009 Sep;40(9):3079-85. doi: 10.1161/STROKEAHA.109.555540. Epub 2009 Jun 25.
citation: Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK, Cen S, Hayden SK; LEAPS Investigative Team. Body-weight-supported treadmill rehabilitation after stroke. N Engl J Med. 2011 May 26;364(21):2026-36. doi: 10.1056/NEJMoa1010790.
citation: Hidler JM, Wall AE. Alterations in muscle activation patterns during robotic-assisted walking. Clin Biomech (Bristol). 2005 Feb;20(2):184-93. doi: 10.1016/j.clinbiomech.2004.09.016.
citation: Mehrholz J, Thomas S, Werner C, Kugler J, Pohl M, Elsner B. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2017 May 10;5(5):CD006185. doi: 10.1002/14651858.CD006185.pub4.
citation: Sale P, Franceschini M, Waldner A, Hesse S. Use of the robot assisted gait therapy in rehabilitation of patients with stroke and spinal cord injury. Eur J Phys Rehabil Med. 2012 Mar;48(1):111-21.
citation: Esquenazi A, Talaty M, Jayaraman A. Powered Exoskeletons for Walking Assistance in Persons with Central Nervous System Injuries: A Narrative Review. PM R. 2017 Jan;9(1):46-62. doi: 10.1016/j.pmrj.2016.07.534. Epub 2016 Aug 24.
citation: Poberznik, A. (2018). Therapeutic use of exoskeletons in spinal cord injury gait rehabilitation-a systematic literature review.
citation: Swank C, Sikka S, Driver S, Bennett M, Callender L. Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. Disabil Rehabil Assist Technol. 2020 May;15(4):409-417. doi: 10.1080/17483107.2019.1587014. Epub 2019 Mar 19.
citation: Pournajaf S, Goffredo M, Agosti M, Massucci M, Ferro S, Franceschini M; Italian Study Group on Implementation of Stroke Care (ISC Study). Community ambulation of stroke survivors at 6 months follow-up: an observational study on sociodemographic and sub-acute clinical indicators. Eur J Phys Rehabil Med. 2019 Aug;55(4):433-441. doi: 10.23736/S1973-9087.18.05489-8. Epub 2018 Dec 13.
citation: Calabro RS, Naro A, Russo M, Bramanti P, Carioti L, Balletta T, Buda A, Manuli A, Filoni S, Bramanti A. Shaping neuroplasticity by using powered exoskeletons in patients with stroke: a randomized clinical trial. J Neuroeng Rehabil. 2018 Apr 25;15(1):35. doi: 10.1186/s12984-018-0377-8.
citation: Morone G, Masiero S, Coiro P, De Angelis D, Venturiero V, Paolucci S, Iosa M. Clinical features of patients who might benefit more from walking robotic training. Restor Neurol Neurosci. 2018;36(2):293-299. doi: 10.3233/RNN-170799.