Examination of the Role of Human Exoskeletons in Rehabilitation

Background and rationale Traumatic spinal cord injury (SCI) has major epidemiological andsocietal impact. Incidence is approximately 12,400 new cases/year in the USA, with aproportionally similar rate expected in Hungary. SCI most often results fromtraffic‐related injuries and typically affects young, previously healthy adults (20‐40years). Depending on neurological level and severity, SCI may causeparaparesis/paraplegia or tetraparesis/tetraplegia, leading to profound functionallimitations and reduced quality of life.For individuals with complete SCI above the lumbar region, independent standing andwalking are generally not achievable with current standard care. Long‐term wheelchair useand immobilization contribute to common secondary complications, including osteoporosis,diabetes mellitus, atherosclerosis, pressure ulcers, depression, and pathologicalfractures. Therefore, a central goal of rehabilitation after complete SCI is to preventor minimize immobilization‐related complications and to support the highest possiblelevel of independence and quality of life.Robotic lower‐limb exoskeletons have been introduced into rehabilitation since the 2000s.These externally worn robotic frames can enable upright standing, walking, andpotentially stair negotiation, supplementing wheelchair mobility. Prior clinical studiesindicate that the ReWalk exoskeleton is feasible and safe for supervised clinicalrehabilitation and, in selected users, for home/community use. Exoskeleton‐assisted gaitproduces measurable cardiorespiratory demands and may replicate some beneficialphysiological effects of able‐bodied walking. Published data suggest possibleimprovements in functional walking capacity compared with some conventional gait‐assistapproaches (e.g., dynamic gait orthoses), and potential benefits in spasticity, as wellas urogenital and gastrointestinal function, patient acceptance, sleep, well‐being, anddepressive symptoms.Based on these findings, the present study is designed to compare outcomes ofReWalk‐based robotic gait rehabilitation with outcomes achieved by conventionalphysiotherapy/fiziotherapy in a similar SCI population, with special attention to domainswhere exoskeleton‐assisted upright mobility may provide added value (e.g., spasticity,bone density, body composition, autonomic functions, and mental health).ObjectivesPrimary objective:To integrate exoskeleton‐assisted gait training into the rehabilitation process andcompare changes in selected functional and physiological parameters with those achievedthrough traditional conservative rehabilitation in patients with paralysis due to SCI.Secondary objectives:To study gastrointestinal and urogenital changes during and after exoskeleton‐basedrehabilitation.To assess general well‐being, patient satisfaction, and compliance/adherence. 3. Studydesign and setting Design: Prospective, controlled clinical study. Duration: Minimum 6months per participant (training plus follow‐up).Groups:Intervention group: ReWalk exoskeleton‐assisted rehabilitation in addition to standardrehabilitation elements.Control group: Patients from the same source population meeting the same eligibilitycriteria but receiving conventional physiotherapy/fiziotherapy only (no exoskeletontraining).Regulatory/quality framework: Conducted in accordance with applicable laws, currentprofessional recommendations, and Good Clinical Practice (GCP) principles.Ethics: Participation requires ethical approval and written informed consent. 4.Participant selection 4.1 Inclusion criteria (FDA‐based)Participants must meet all of the following:Complete SCI below T4 with paraparesis/paraplegia. At least 4 months since the SCI event.Adequate upper‐limb and shoulder strength to use forearm crutches. Adequate bone density,supported by DXA when required: hip T‐score greater than ‐3.5.Intact skeletal system: in addition to a stable or stabilized spine, there is no fresh,non‐consolidated fracture that could affect device use or walking.Ability to stand confidently using a standing aid such as EasyStand (or similar).Good general health.Anthropometrics compatible with the device:Height 160‐190 cm Femur length 43.5‐56 cm Tibia length 36‐48.5 cm Body weight maximum 100kg.Adequate lower‐limb range of motion:Physiological ankle position Hip extension to 0° Knee contracture less than 10° 4.2Exclusion criteria (FDA‐based)Any of the following will exclude participation:Severe neurological disease other than traumatic SCI (e.g., multiple sclerosis, cerebralpalsy, ALS, traumatic brain injury).Severe comorbidities that limit safe training (e.g., active infection, significantcardiovascular disorder affecting load tolerance, pulmonary disease).Abdominal or thoracic conditions that prevent safe exoskeleton use (e.g., enterostoma,chest deformity), or pressure ulcers that interfere with device wearing.Severe spasticity (Modified Ashworth Scale score 4). Unstable spine or lower‐limb/pelvicconditions limiting load‐bearing (e.g., non‐healed fracture, post‐amputation state).Heterotopic ossification that restricts joint mobility beyond allowed limits.Significant contractures:Plantar flexion contracture greater than 0° Knee contracture greater than 10° Hip flexioncontracture 20° Psychiatric or cognitive impairment that limits safe device handling orstudy participation.Pregnancy. 5. Intervention and rehabilitation protocol 5.1 Safety and supervisionParticipants are under continuous medical supervision during treatment. Exoskeletontraining is taught and delivered by trained movement therapists. Until independentwalking with the device is achieved, at least two physiotherapists ensure safe use.In early phases, sessions occur 5 times per week, 60‐90 minutes per session. After aparticipant acquires safe independent use, training continues and follow‐up assessmentsproceed for at least 6 months. For long‐term maintenance, session frequency may bereduced (see follow‐up phase).A multidisciplinary team supports assessment and management of outcomes, including aninternist, a urologist experienced in urodynamic testing, a dietitian, and a clinicalpsychologist, as required for physiological and mental‐health endpoints.5.2 Stepwise training phases Phase 1: Preparatory physiotherapy‐trunk and upper‐limbstrengtheningTo safely control the robotic device, specific motor capacities are required. Amulti‐week preparatory program is conducted, focusing on:Improving sitting balance, essential for safe device use. Strengthening abdominal andparavertebral muscles (performed in supine, prone, quadruped, and especially seatedpositions).Training dynamic trunk balance (with or without supportive tools). Strengthening upperlimbs due to increased load from crutch‐assisted walking during exoskeleton use.Progress is assessed weekly using the Trunk Control Measurement Scale. If the participantreaches 15/58 points, the program proceeds to the next phase.Phase 2: Donning/doffing, sit‐to‐stand and stand‐to‐sit, standing balanceParticipants learn:Independent donning of the device. Safe standing up and sitting down techniques.Standing balance and weight shifting tasks, including:Standing with one crutch (as appropriate) Maneuvering and turning tasks Trunk control andbalance are assessed repeatedly using the Trunk Control Measurement Scale and the BergBalance Scale. Advancement requires safe, independent task execution, stablefrontal‐plane weight shifting, and the ability to safely lift and reposition crutches.Phase 3: Gait acquisitionParticipants learn independent device operation using manufacturer/FDA‐defined stepsettings. Progress is evaluated with:Intermediate Skill Test every 2 weeks 10‐Meter Walk Test every 2 weeks Timed Up and Go(TUG) every 2 weeks After 8 weeks, if the participant can control and use the devicesafely, the Final Skill Test is performed.Phase 4: Stair training If Final Skill Test competencies are met, stair negotiationskills are introduced as the final step of training.Phase 5: Follow‐up/maintenance phase For participants capable of independent use, therapyfrequency may be reduced to three sessions per week as maintenance therapy, whilefollow‐up measurements continue per schedule.6. Outcome measures and assessments 6.1 Ongoing safety monitoringAt each session:Vital signs are measured and documented (blood pressure, heart rate). Skin is inspectedfor irritation/pressure injury before and after device use.If skin irritation or injury occurs:Lesion extent is monitored (diameter, longitudinal and transverse dimensions), withspecial focus on depth.Photo documentation is performed. Findings are categorized according to National PressureUlcer Advisory Panel (NPUAP) recommendations.If injury occurs at a device contact point, or if skin/soft tissue/bone injury issuspected, device use must be suspended.All relevant events and observations are recorded; documentation includes images andvideo as applicable.6.2 Baseline assessments (at enrollment) ASIA Impairment Scale (AIS) and Frankel scaleBone densitometry (DXA) Body composition measurement Spasticity: Modified Ashworth Scale(mAS) Barthel Index Functional Independence Measure (FIM) Pain and fatigue: Visual AnalogScale (VAS) Quality of life: SF‐36 Mental health: Beck Anxiety Inventory and BeckDepression Inventory (as specified) ReWalk medical clearance form Lower‐limbcircumference measurement 6.3 Assessments at major milestones (minimum at acquisition ofnew skills / next training level) Barthel Index FIM VAS pain/fatigue Trunk ControlMeasurement Scale Modified Ashworth Scale (mAS) 10‐Meter Walk Test Timed Up and Go (TUG)Spinal Cord Independence Measure (SCIM) Berg Balance Scale ReWalk skill tests (asscheduled) 6.4 Follow‐up phase assessments Bone densitometry (DXA) FIM Modified AshworthScale (mAS) SCIM SF‐36 Beck anxiety and depression questionnaires Compliance andsatisfaction assessed using a 5‐point Likert scale 7. Expected outcomesCompared with conventional rehabilitation alone, ReWalk exoskeleton‐assisted gaitrehabilitation is expected to be associated with:Improved body composition and improved or preserved bone density, reflecting benefits ofupright, load‐bearing, and increased physical activity.Improved general well‐being, patient satisfaction, and treatment adherence/compliance.8. Summary This prospective, controlled clinical study evaluates the added value ofintegrating ReWalk exoskeleton‐assisted gait training into SCI rehabilitation. Bycomparing a ReWalk intervention group with a matched control group receiving conventionaltherapy only, the study aims to quantify functional, physiological, autonomic, andpsychosocial effects of robotic upright mobility, while maintaining rigorous safetymonitoring and standardized outcome assessments over a minimum 6‐month period.