CLINICAL RESEARCH BACKED BY LEADING NEUROREHAB HOSPITALS

Clinical Evidence

Clinical trials have been performed in European centres of excellence in rehabilitation, proving the safety and performance of the exoskeleton for persons with spinal cord injury. Results have been published in peer-reviewed scientific journals with high impact factors.

Improved clinical outcomes:

Dosage and tolerance for gait training.
Patient quality of life and well-being.
Patient mobility independence.
Body motor function (incomplete SCI).
Walk time and number of steps.
Therapist efficiency and patient safety.
Therapy and patient satisfaction

Scientific Publications

Enhancing exoskeleton technology through co-creation with clinicians and patients: A pilot study and comparative analysis of the ABLE Exoskeleton

E. Porras-Martínez, K. Kreamer-Tonin, J. Lobo-Prat, H. López-Matas, A. Carnicero-Carmona, M. Tolrà-Campanyà, F. Pérez-Cañabate, J. Estay-Girardi & B. Samitier-Pastor. Disability and Rehabilitation, vol 1, 15 (2025).

All 5 participants completed all training activities with the majority (4/5) requiring minimal assistance after 9 training sessions.
The average walking-standing ratio per session with the ABLEhipknee was at least 77.2% higher than the average accomplished in the studies with the ABLEknee.
Compared to previous studies with the ABLEknee, participants with similar injury characteristics achieved at least 3 times more steps and covered 7 times more distance with the ABLEhipknee.
The highest-rated categories were safety, comfort, and effectiveness, all of which were notably superior to the scores obtained in the other two clinical trials with the ABLEknee.
The results of the comparative analysis showed that in a population with high thoracic, motor-complete injuries, the ABLEhipknee version exhibits a better performance than the ABLEknee version
The co-creation methodology presented in this study has led to the development of an enhanced version of the ABLE Exoskeleton.

Read full publication

User-centered design of a personal-use exoskeleton: a clinical investigation on the feasibility and usability of the ABLE Exoskeleton device for individuals with spinal cord injury to perform skills for home and community environments

F. Nadorf, M.A. Wright, H. López-Matas, E. Porras, A. Carnicero-Carmona, C. Hensel, S. Franz, N. Weidner, J. Vidal, E. Opisso & R. Rupp. Frontiers in Neuroscience, vol 18, 1437358 (2024).

Donning and doffing of the device required an average total time of 10 minutes and 23 seconds with the majority of participants (80%) requiring only minimal assistance or less.
At least 50% of participants were able to complete 4 out of the 6 basic skills only with supervision or less.
The median duration to complete the Home-Skills-Test was 7:45 min:sec and half of the skills in the test were performed by at least 50% of participants with only supervision or better.
The Dimensions of the device was the best-rated category among physiotherapists, followed by Comfort, Weight and Ease of use
Positive perceived improvement in 5 out of the 7 categories assessed when training with the ABLE Exoskeleton: cardiovascular fitness, musculoskeletal pain, bladder/bowel, spasticity, and sleep quality.

Read full publication

Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury: a framework towards the standardisation of clinical evaluations

M.A. Wright, F. Herzog, A. Mas-Vinyals, A. Carnicero-Carmona, J. Lobo-Prat, C. Hensel, S. Franz, N. Weidner, J. Vidal, E. Opisso & R. Rupp. Journal of NeuroEngineering and Rehabilitation, vol 20, 45 (2023)

The ABLE Exoskeleton is safe and feasible for gait training in persons with SCI.
It was feasible for all the participants to don and doff the device within an efficient timeframe.
Improvements in level of assistance and gait parameters (time, steps, distance and speed) were observed in all participants.
The findings of the psychosocial impact assessment suggest that it may have a positive impact on quality of life and well-being.
Walking function and RPE improved in participants able to complete walking tests with and without the device.

Read full publication

Comparing walking with knee-ankle-foot orthoses and a knee-powered exoskeleton after spinal cord injury: a randomised, crossover clinical trial

A. Rodríguez-Fernández, J. Lobo-Prat, R. Tarragó, D. Chaverri, X. Iglesias, L. Guirao-Cano, J.M. Font-Llagunes. NATURE Scientific Reports, vol. 12, 19150 (2022).

Participants had a more natural walking pattern (less compensatory movements, better weight shifting, and longer step length) when walking with the ABLE Exoskeleton.
9 out of the 10 participants did the final test with the automatic step initiation trigger and used the remote controller to control state transitions.
Walking with the ABLE Exoskeleton is less conditioned by the LOI of the user compared to walking with KAFOs.
Training with the ABLE Exoskeleton met the recommendations of exercise intensity for people with SCI. 
The ABLE Exoskeleton was considered significantly safer than the KAFOs, and was evaluated as more comfortable and easier to use and adjust than the KAFOs.

Read full publication