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Rehabilitation of neurologically impaired and spinal cord injured: exoskeleton trial

Physiological, biomechanical, and emotional responses to a 12-week exoskeleton-based physical activity and home-based strength training intervention among individuals with neurological impairments

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11222157
Enrollment
12
Registered
2022-07-20
Start date
2022-06-07
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

Rehabilitation of individuals with neurological impairments Nervous System Diseases

Interventions

Individuals with neurological impairments will complete a 12-week exoskeleton-based physical activity and home-based strength training intervention. Participants will complete three sessions per week
one exoskeleton-based walking session with The No Barriers Foundation lasting up to 1 hour, and two home-based strength training sessions. The Ekso NR™ is the exoskeleton that will be used throughout

Sponsors

Atlantic Technological University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults with a neurological impairment (e.g., spinal cord injury, multiple sclerosis, acquired brain injury, stroke) 2. Aged 18-70 years old 3. Height: =157.5 and =188 cm and body mass: =100 kg 4. Able to signal pain, discomfort, or fear reliably 5. Functional joint mobility (ankle dorsiflexion = neutral; knee flexion = 0–120°; hip flexion = 0–90°; and hip extension = 0–10°) 6. No orthopaedic surgery or neurosurgery within 6 months prior 7. A stable cardiovascular system

Exclusion criteria

Exclusion criteria: 1. Contractures, fractures or joint dislocations in the lower extremities 2. Osteoporosis 3. Height: 188 cm and body mass >100 kg 4. Unequal leg length 5. Unhealed skin lesions in the lower limbs 6. Thromboembolic diseases or cardiovascular instability

Design outcomes

Primary

MeasureTime frame
The physiological response to the intervention, measured using: 1. A range of cardiorespiratory measurements generated by the Ganshorn PowerCube® 2. HR recorded using a Polar FT2 (GEN 90037558, Electro, Finland) chest strap HR monitor 3. RPE measured using the Borg Scale (6-20 scale) These measurements will be recorded throughout the 6MWT, which will be conducted at baseline, mid, and post-intervention.

Secondary

MeasureTime frame
1. Gait function is measured using the 6MWT which includes total walking distance and walking speed and will be recorded at baseline, mid, and post intervention 2. Functional mobility will be measured by a qualified and registered chartered physiotherapist using specific exoskeleton protocols at baseline, mid, and post intervention 3. Biomechanical response will be measured using Shimmer 3 EMG sensors, which will record lower limb muscle activation, acceleration and angular velocity throughout the 6MWT at baseline, mid, and post intervention 4. Emotional response will be measured using a Shimmer 3 GSR+ unit during the 6MWT at baseline, mid, and post intervention 5. Quality of life will be measured using the EQ-5D-5L quality of life questionnaire developed by EuroQol at baseline, mid, and post intervention

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026