Clinical trial · Interventional
Gait Training Through a Novel Over-ground Wearable Robotic System in People with Pyramidal Hemisyndromes
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Injuries, Traumatic | — | UNRESOLVED | — |
| Brain Tumor Benign | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indego Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Indego-Assisted Gait Rehabilitation
- description
- 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.
- interventionNames
- Device: Indego Therapy
Primary outcomes (1)
- measure
- Changes in 6 Minute Walk Test (6MWT)
- timeFrame
- Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (20)
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- BACKGROUNDPerry J. Analisi del movimento. Elsevier Italia srl, Milano 2005.
- BACKGROUNDPearson 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. PMID 8460894
- BACKGROUNDBarbeau 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. PMID 3607464
- BACKGROUNDDietz 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. PMID 7851518
- BACKGROUNDEdgerton 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. PMID 15217329
- BACKGROUNDRichards 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.