Towards low-complexity robotic exoskeleton: benchmarking and benefits for spinal cord injury patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202601530951871

Enrollment

Registered

2026-01-05

Start date

2025-05-15

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury, Occupational Diseases, Poisoning

Interventions

EXOPS Robotic Exoskeleton

Conventional Passive Orthotics

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults aged 18–64 years. Body Mass Index (BMI) between 17–29.9 kg/m². Traumatic spinal cord injury (SCI) confirmed by MRI. Neurological level of injury between D4–D12. Duration of injury = 3 months. Ability to participate in rehabilitation and follow instructions.

Exclusion criteria

Exclusion criteria: Associated head injury or cognitive dysfunction. Severe spasticity: Modified Ashworth Scale (MAS) = 3. Uncontrolled chronic diseases: Hypertension (resting BP = 160/100 mmHg) Diabetes (random glucose >16.7 mmol/L or HbA1C >7.0%) Severe organic disease (cardiovascular, pulmonary, liver failure, CKD stage =3) Severe peripheral vascular disease Other neurological disorders: stroke, multiple sclerosis, Parkinsonism. Poor compliance or inability to cooperate with assessment or training. Combined mental disorders. Enrollment in another rehabilitation program.

Design outcomes

Primary

Measure	Time frame
Distance walked, 6-Minute Walk Test (6MWD, total distance in meters);Oxygen consumption (VO2) using K5 Cosmed device;Metabolic cost, measured using K5 Cosmed device;Physiological Cost Index (PCI), measured using Heart rate: (Working HR – Resting HR) / walking speed;Spasticity, measured using Modified Ashworth Scale (MAS) & nerve conduction (F/M and H/M ratios);Bowel & bladder function, measured using Clinical exam & monomeric biofeedback (resting/max anal pressure);Gait & postural assessment, measured using Force platform (COP, symmetry, ground reaction forces), gait lab (stride length, speed, stance/swing times, step length, double limb support)	—

Measure

Time frame

Distance walked, 6-Minute Walk Test (6MWD, total distance in meters);Oxygen consumption (VO2) using K5 Cosmed device;Metabolic cost, measured using K5 Cosmed device;Physiological Cost Index (PCI), measured using Heart rate: (Working HR – Resting HR) / walking speed;Spasticity, measured using Modified Ashworth Scale (MAS) & nerve conduction (F/M and H/M ratios);Bowel & bladder function, measured using Clinical exam & monomeric biofeedback (resting/max anal pressure);Gait & postural assessment, measured using Force platform (COP, symmetry, ground reaction forces), gait lab (stride length, speed, stance/swing times, step length, double limb support)

—

Secondary

Measure	Time frame
Functional Ambulation, measured using Walking Index for Spinal Cord Injury (WISCI-II);Pain, measured using Visual Analog Scale (VAS);Fatigue, measured using Visual Analog Scale VAS;Quality of Life, measured using SF-12 Version 2 (Physical & Mental Health composite scores);Heart rate & oxygen saturation, measured during 6MWT;Adverse Events, Patient-reported; monitored by therapist	—

Countries

Egypt

Contacts

Public ContactShereen Ismail Fawaz

Assistant Lecturer

shereen_fawaz@med.asu.edu.eg+201001242964

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026