Clinical Research Directory

Examination of the Role of Human Exoskeletons in Rehabilitation

Sponsor: University of Pecs

Summary

Background and Rationale: Traumatic spinal cord injury (SCI) affects approximately 12,400 individuals annually in the USA, predominantly impacting healthy young adults aged 20-40 years. Complete SCI above the lumbar region results in paraplegia or tetraplegia, severely compromising quality of life. Wheelchair-dependent lifestyle and immobilization lead to serious secondary complications including osteoporosis, diabetes mellitus, atherosclerosis, pressure ulcers, depression, and pathological fractures. Robotic exoskeletons have emerged as promising rehabilitation tools since the 2000s, enabling independent walking and stair climbing beyond wheelchair use. Study Objectives: This clinical trial investigates the role of ReWalk lower-limb human exoskeleton in rehabilitation by: Integrating exoskeleton-assisted gait training into rehabilitation protocols and comparing functional and physiological outcomes with conventional conservative treatment in SCI-induced paralysis Examining gastrointestinal and urogenital changes Assessing general well-being and patient compliance Methods: This prospective, controlled study enrolls patients with lower limb paralysis following SCI for minimum 6-month rehabilitation. The control group receives traditional physiotherapy and physical rehabilitation only. All procedures comply with Good Clinical Practice principles and applicable regulations. Inclusion criteria (FDA-approved): Complete SCI below T4 with paraparesis/paraplegia; ≥4 months post-injury; adequate arm/shoulder strength for crutch use; appropriate bone density (hip t-score \>-3.5); intact skeletal system with stable spine; ability to stand safely; good general health; height 160-190cm; weight ≤100kg; adequate lower limb range of motion. Exclusion criteria: Severe neurological diseases beyond SCI; significant concurrent illnesses; severe spasticity (Modified Ashworth 4); unstable spine or limbs; heterotopic ossification; significant contractures; psychiatric/cognitive impairment; pregnancy. Training Protocol: The rehabilitation program consists of five phases: Paravertebral and back muscle strengthening (weeks 1-4): Core strengthening exercises focusing on sitting balance, assessed weekly via trunk control measurement scale Standing, sitting, and device donning (weeks 5-6): Learning independent device application and safe standing balance Gait training (weeks 7-8): Mastering independent device control through various stepping patterns Stair training (weeks 9+): Learning stair negotiation after passing final skill test Follow-up phase (6+ months): Maintenance therapy at reduced frequency (3x/week) Assessment Parameters: Baseline assessments include: ASIA Impairment Scale, bone densitometry, Modified Ashworth Scale, Barthel Index, Functional Independence Measure (FIM), VAS pain/fatigue scales, SF-36, Beck's anxiety/depression inventories. Progress evaluations at major milestones include functional tests (10-meter walk, Timed Up-and-Go, Berg Balance, Spinal Cord Independence Measure) and ReWalk skill assessments. Follow-up assessments (6-month minimum) repeat baseline measures focusing on bone density, functional independence, quality of life, and mental health. Expected Outcomes: Improved bone density with exoskeleton training compared to conventional treatment Improved general well-being and better patient compliance This study aims to confirm previous international findings demonstrating superior outcomes with robotic rehabilitation technology regarding spasticity reduction, bone density preservation, body composition improvement, and gastrointestinal/urogenital/mental health enhancement compared to traditional treatment approaches.

Official title: The Effect of High Intensity Exoskeleton Assisted Gait Training for Spinal Cord Injured Patients

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