Spinal Cord InjuryNCT07036107
A Trial on the Clinical and Socioeconomic Impact of Wearable Exoskeletons for Spinal Cord Injury Rehabilitation in the Spanish Healthcare System
A study testing ABLE Exoskeleton and Conventional therapy in people with Spinal Cord Injury, run by ABLE Human Motion S.L. at 2 sites in Spain.
Trial summary
This clinical trial aims to collect evidence on the clinical benefits and the socioeconomic impact of integrating a novel wearable powered lower-limb exoskeleton for gait rehabilitation in acute/subacute spinal cord injured individuals and to evaluate the efficiency of this technology to the current standard of care… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- ABLE Exoskeleton and Conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Jan 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of spinal cord injury (SCI) in the acute or subacute phase (< 6 months of evolution)
- traumatic or non-traumatic aetiology
- neurological level of the SCI between C5 and L5 for patients with American Spinal Injury Association Impairment Scale (AIS) C or D, and SCI between C7 and L5 for patients with AIS A or B.
- sufficient strength in the upper extremities to handle a walker (triceps muscle score ≥ 4 according to the Medical Research Council (MRC) scale).
- range of motion (ROM) without limitations in the lower extremities (achieve at least a knee extension of 10 degrees and neutral ankle position)
- muscle spasticity in the lower extremities with a score ≤ 3 on the Modified Ashworth Scale (MAS)
- tolerate bipedalism (having stood up in the last year)
- aged between 18 and 70 years, with height between 150 cm and 190 cm, and weight less than 100 kg
Who cannot join
- WISCI ≥ 15
- cognitive or neurological limitations that prevent following instructions
- another neurologic disorder permanently affecting gait and gait therapy (other than SCI)
- grade I or higher in the European Pressure Ulcer Advisory Panel (EPUAP) in the areas of contact with the exoskeleton
- unresolved fractures at the time of the study
- uncontrolled autonomic dysautonomia
Show all 12Show fewer
- intolerance to exercise
- uncontrolled epilepsy
- previous experience with Robotic-Assisted Gait Training (RAGT).
- ROM restriction such as flexing or arthrodesis will be excluded
- spinal instability (or spinal orthotics unless cleared by a medical doctor).
- deterioration >3 points of the total in the motor score of the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) in the last 4 weeks. Loss of sensation and/or motor activity above the level of injury detected that has not been evaluated by a doctor.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario de Vall d'Hebron
Barcelona, Catalonia, 08035
Lluïsa Montesinos Magraner, Dr, 620951308, lluisa.montesinos@vallhebron.cat
Lluïsa Montesinos Magraner, Dr
- Not yet recruiting
Hospital Nacional de Parapléjicos
Toledo, Castille-La Mancha, 45071
Ana de los Reyes Guzmán, PhD, 925247771, adlos@sescam.jccm.es
Ana de los Reyes Guzmán, PhD
About this study
Official title: Robotic-SNS: A Multicenter, Randomized Trial on the Clinical and Socioeconomic Impact of Wearable Exoskeletons for Spinal Cord Injury Rehabilitation in the Spanish Healthcare System
This clinical trial aims to collect evidence on the clinical benefits and the socioeconomic impact of integrating a novel wearable powered lower-limb exoskeleton for gait rehabilitation in acute/subacute spinal cord injured individuals and to evaluate the efficiency of this technology to the current standard of care in the Spanish Healthcare System (SNS).. The main questions it aims to answer are:
- Is robotic therapy for gait rehabilitation more effective and efficient than conventional therapy?
- Does robotic therapy for gait rehabilitation reduce the burden on healthcare professionals and caregivers?
- Does robotic therapy for gait rehabilitation reduce direct healthcare costs?
- Does robotic therapy for gait rehabilitation reduce intervention-related costs?
Read more
Researchers will compare a novel wearable powered lower-limb exoskeleton for gait rehabilitation to conventional therapy to see if the robotic exoskeleton is more effective and efficient in improving clinical benefits and to assess if it reduces the burden of healthcare professionals and caregivers, as well as healthcare and intervention-related costs.
Participants will:
- Be randomized on a 1:1 basis to receive rehabilitation treatment with either the robotic exoskeleton or conventional therapy for gait recovery, 3 times a week on non-consecutive days for 8 weeks (24-session program).
- Undergo a pre- and post-intervention assessment of clinical, functional, physiological, psychological, and socioeconomic variables.
- Have a follow-up visit 2 months after the end of the treatment.
Read the detailed description
Participants will be recruited from among patients admitted to the institutions involved in the project: Vall d'Hebron University Hospital (HVH) through its research institute (VHIR) and the National Hospital for Paraplegics of Toledo (HNP), through its research foundation (FHNP). After checking the inclusion and exclusion criteria, informing the patient and signing the consent, they will be randomly distributed between the control group (CG) and the intervention group (IG). Open random parallel groups. The IG will receive rehabilitation treatment with the ABLE Exoskeleton, while the CG will receive conventional therapy for gait rehabilitation. The latter includes joint mobilizations, strengthening of paretic muscles and re-education of walking with parallel bars, making use of the technical aids and orthoses required by the patient (KAFOs, crutches and walkers). For both groups, participation in the study is based on a baseline visit, the 24-session rehabilitation treatment (including mid-training and end-training assessments at 12-session and 24-session, respectively) and a follow-up visit two months after the end of the treatment. Caregiver overload will also be assessed at baseline visit, after patient's treatment and at the follow-up visit two months after patient treatment.
- Conditions
- Spinal Cord Injury
- Being tested
- ABLE Exoskeleton, Conventional therapy
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABLE ExoskeletonDevice
Participants will receive a 24-session rehabilitation treatment program with the ABLE Exoskeleton, 3 times a week for up to 8 weeks
Conventional therapyOther
Participants will receive a 24-session conventional therapy program for gait rehabilitation, 3 times a week for up to 8 weeks.
Conventional therapy includes joint mobilizations, strengthening of paretic muscles and re-education of walking with parallel bars, making use of the technical aids and orthoses required by the patient (KAFOs, crutches and walkers).
| Study group | Role | What they receive |
|---|---|---|
| Robotic exoskeleton | Experimental | The intervention group will receive rehabilitation treatment with the ABLE Exoskeleton Receives: Device: ABLE Exoskeleton |
| Conventional therapy | Active comparator | The control group will receive conventional therapy for gait rehabilitation Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walking ability
The walking ability will be assessed using the Walking Index Spinal Cord Injury (WISCI) II which evaluates the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from Spinal Cord Injury (SCI).
The WISCI II score ranges from 0 to 20 (0: the individual is unable to walk, 20: the individual walks without assistance or devices)
Measured: Baseline , end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)
Change in Balance
The balance will be assessed by the time taken to complete the Timed-Up-and-Go (TUG) test which evaluates mobility and balance.
Measured: Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)
Change in Gait speed
The gait speed will be assessed by the time taken to complete the 10 meter Walk Test (10mWT) which evaluates walking speed in meters per second over a short duration.
Measured: Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)
Change in Lower Extremity Motor Score (LEMS)
The Lower Extremity Motor Score (LEMS) evaluates motor function on a scale of 0 (no motor function) to 5 (full motor function) for 5 lower extremity muscle groups with a 50-point maximum (25 per side).
Measured: Baseline, mid-training (at 4 weeks), end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)
Change in Trunk control
The trunk control will be assessed using the Trunk Assessment Scale for Spinal Cord Injury (TASS). The TASS consists of nine sitting tasks without upper-limb support: one task is static, and the other eight tasks are dynamic. Each item is assigned a score of 0-2, 0-4, or 0-6 for a total score of 44, with higher scores indicating better trunk function.
Measured: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)
Change in Endurance
Endurance will be assessed by the distance (in meters) walked during the 2-Minute Walk Test (2MWT), which evaluates walking capacity and functional mobility.
Measured: Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)
Change in Endurance
Endurance will be assessed by the distance (in meters) walked during the 6-Minute Walk Test (6MWT), which evaluates walking capacity and functional mobility.
Measured: Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)
Change in Level of Exertion
Perceived exertion associated with the walking test (2MWT/6MWT) will be assessed using the Borg Rating of Perceived Exertion Scale, a self-report scale ranging from 0 to 10. A score of 0 indicates no exertion, and 10 indicates maximal exertion. Higher scores represent greater perceived exertion.
Measured: Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)
Change in Gait pattern
The gait pattern and compensatory movements will be assessed through kinetic and kinematic gait parameters collected using a 3-D gait analysis system. The Gait Deviation Index for SCI (SCI-GDI) will be calculated to evaluate the difference between the patient' gait pattern compared to the reference gait pattern.
The SCI-GDI score typically ranges from 0 to 100, with 100 representing a normal gait pattern.
Measured: Baseline, mid-training (at 4 weeks), end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)
Change in Bladder and Bowel function
Bladder and bowel function will be assessed using the International Standards to document Autonomic Function following SCI (ISAFSCI), which identifies which autonomic functions (e.g., bladder, bowel) are intact, impaired, or lost.
Measured: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)
Change in Bladder and Bowel function
Bowel function will also be assessed using the Neurogenic Bowel Dysfunction score (NBD score), a self-report questionnaire.
The total NBD score ranges from 0 to 47, with higher scores indicating more severe dysfunction.
Measured: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)
Change in Bone density
The Bone density will be assessed through analytical control, 24-hour urine, and dual-energy X-ray absorptiometry (DEXA) scan in the spine, hip and knee.
Measured: At baseline and end of treatment (at 8 weeks)
Change in Cardiovascular function
The cardiovascular function will be asssessed by an arm ergometry test, which is a test that measures the heart's response to physical exertion. The maximum heart rate (HR) will be documented.
Measured: At baseline and end of treatment (at 8 weeks)
Change in Respiratory function
The respiratory function will be assessed by a simple spirometry, which is a test that measures the volume of air exhaled in one second (FEV1) and the total volume of air exhaled forcefully (FVC).
Measured: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)
Pain reduction
The reduction in pain will be assessed using International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) which is used to document the interference of pain with physical and emotional function and sleep, probable pain diagnosis, location, intensity and duration.
Each value is scored on a 0 to 10 numerical rating scale, where 0 represents no pain and 10 represents the worst pain imaginable.
Measured: From baseline to follow-up (at 2 months after the end of treatment)
Change in Spasticity
The spasticity in the lower limbs will be assessed using both the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) score, which evaluates three types of spastic motor behaviors in SCI patients - clonus, flexor spasms, and extensor spasms, as well as the Modified Ashworth Scale (MAS).
SCATS total score (0-9; higher = worse outcome)
Measured: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after the end of treatment)
Change in Functional independence
The functional independence will be assesed using the Spinal Cord Independence Measure III (SCIM III) which is a patient-reported outcome measure that evaluates three main domains: self-care, respiration and sphincter management, and mobility. The SCIM III score is calculated on a scale of 0-100, with 0 indicating complete dependence and 100 indicating complete independence.
Measured: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after the end of treatment)
Change in Quality of Life
Quality of life will be assessed using the 5-level EQ-5D version (EQ-5D-5L), a standardized instrument for measuring generic health status.
Ranging from 1 (best possible health) to values less than 0.
Measured: At baseline and end of treatment (at 8 weeks)
Change in Quality of Life
Emotional well-being will be assessed using the Hospital Anxiety and Depression Scale (HADS), which measures anxiety and depression.
Score on HADS subscales (0-21 per subscale; with higher numbers indicating a greater level of anxiety or depression)
Measured: At baseline and end of treatment (at 8 weeks)
Change in Quality of Life
Motivation will be assessed using the interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI).
Interest/Enjoyment score on IMI subscale (1-7; where 1 represents "Not at all true" and 7 represents "Very true")
Measured: At baseline and end of treatment (at 8 weeks)
Burden of healthcare professionals
The burden on healthcare professionals will be assessed using the NASA Task Load Index (NASA-TLX), a self-report questionnaire to assess work load on five 7-point scales. NASA-TLX scores can range from 0 to 100, where a higher score generally indicates a higher workload
Measured: At end of treatment (8 weeks)
Change in Burden of the caregiver
The caregiver burden will be assessed using the Zarit Burden Interview, a 22-item self-report questionnaire which total score ranges from 0 to 88. The higher the value, the higher the caregiver burden.
Measured: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after the end of treatment)
Change in Direct healthcare costs
The medical costs including hospitalization days, transportations, specialists consultations, rehabilitation services, emergency room visits, and hospital admissions will be calculated.
Measured: Baseline (Day 0), end of treatment (8 weeks), and follow-up (16 weeks)
Intervention-related costs
The costs associated to the rehabilitation sessions, treatment, and equipment during the intervention period will be calculated.
Measured: At the end of treatment (8 weeks)
Change in the productivity losses
Variation in indirect costs for patient and caregiver, associated with reduced work capacity, absenteeism, or early retirement, as a result of the intervention.
Measured: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after the end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start15 Jan 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ABLE Human Motion S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo, Universitat de Lleida, Hospital Universitari Vall d'Hebron Research Institute
- Responsible party
- Sponsor
- Investigators
- Lluïsa Montesinos Magraner, Dr, Principal investigator, Hospital Universitario de Vall d'HebronAna de los Reyes Guzmán, PhD, Principal investigator, Hospital Nacional de Parapléjicos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036107
- Sponsor's protocol ID
- Robotic-SNS
- Status last verified
- Jan 2026
- First submitted
- 6 Jun 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-SNS: A Multicenter, Randomized Trial on the Clinical and Socioeconomic Impact of Wearable Exoskeletons for Spinal Cord Injury Rehabilitation in the Spanish Healthcare System
- ClinicalTrials.gov ID
- NCT07036107
- Acronym / sponsor ID
- Robotic-SNS
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ABLE Human Motion S.L.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo, Universitat de Lleida, Hospital Universitari Vall d'Hebron Research Institute
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to collect evidence on the clinical benefits and the socioeconomic impact of integrating a novel wearable powered lower-limb exoskeleton for gait rehabilitation in acute/subacute spinal cord injured individuals and to evaluate the efficiency of this technology to the current standard of care in the Spanish Healthcare System (SNS).. The main questions it aims to answer are:
- Is robotic therapy for gait rehabilitation more effective and efficient than conventional therapy?
- Does robotic therapy for gait rehabilitation reduce the burden on healthcare professionals and caregivers?
- Does robotic therapy for gait rehabilitation reduce direct healthcare costs?
- Does robotic therapy for gait rehabilitation reduce intervention-related costs?
Researchers will compare a novel wearable powered lower-limb exoskeleton for gait rehabilitation to conventional therapy to see if the robotic exoskeleton is more effective and efficient in improving clinical benefits and to assess if it reduces the burden of healthcare professionals and caregivers, as well as healthcare and intervention-related costs.
Participants will:
- Be randomized on a 1:1 basis to receive rehabilitation treatment with either the robotic exoskeleton or conventional therapy for gait recovery, 3 times a week on non-consecutive days for 8 weeks (24-session program).
- Undergo a pre- and post-intervention assessment of clinical, functional, physiological, psychological, and socioeconomic variables.
- Have a follow-up visit 2 months after the end of the treatment.
Detailed description
Participants will be recruited from among patients admitted to the institutions involved in the project: Vall d'Hebron University Hospital (HVH) through its research institute (VHIR) and the National Hospital for Paraplegics of Toledo (HNP), through its research foundation (FHNP). After checking the inclusion and exclusion criteria, informing the patient and signing the consent, they will be randomly distributed between the control group (CG) and the intervention group (IG). Open random parallel groups. The IG will receive rehabilitation treatment with the ABLE Exoskeleton, while the CG will receive conventional therapy for gait rehabilitation. The latter includes joint mobilizations, strengthening of paretic muscles and re-education of walking with parallel bars, making use of the technical aids and orthoses required by the patient (KAFOs, crutches and walkers). For both groups, participation in the study is based on a baseline visit, the 24-session rehabilitation treatment (including mid-training and end-training assessments at 12-session and 24-session, respectively) and a follow-up visit two months after the end of the treatment. Caregiver overload will also be assessed at baseline visit, after patient's treatment and at the follow-up visit two months after patient treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic exoskeleton | Experimental | Device: ABLE ExoskeletonThe intervention group will receive rehabilitation treatment with the ABLE Exoskeleton |
| Conventional therapy | Active comparator | Other: Conventional therapyThe control group will receive conventional therapy for gait rehabilitation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- diagnosis of spinal cord injury (SCI) in the acute or subacute phase (< 6 months of evolution)
- traumatic or non-traumatic aetiology
- neurological level of the SCI between C5 and L5 for patients with American Spinal Injury Association Impairment Scale (AIS) C or D, and SCI between C7 and L5 for patients with AIS A or B.
- sufficient strength in the upper extremities to handle a walker (triceps muscle score ≥ 4 according to the Medical Research Council (MRC) scale).
- range of motion (ROM) without limitations in the lower extremities (achieve at least a knee extension of 10 degrees and neutral ankle position)
Key exclusion criteria (12 listed)
- WISCI ≥ 15
- cognitive or neurological limitations that prevent following instructions
- another neurologic disorder permanently affecting gait and gait therapy (other than SCI)
- grade I or higher in the European Pressure Ulcer Advisory Panel (EPUAP) in the areas of contact with the exoskeleton
- unresolved fractures at the time of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABLE ExoskeletonParticipants will receive a 24-session rehabilitation treatment program with the ABLE Exoskeleton, 3 times a week for up to 8 weeks | Device | Robotic exoskeleton |
| Conventional therapyParticipants will receive a 24-session conventional therapy program for gait rehabilitation, 3 times a week for up to 8 weeks. Conventional therapy includes joint mobilizations, strengthening of paretic muscles and re-education of walking with parallel bars, making use of the technical aids and orthoses required by the patient (KAFOs, crutches and walkers). | Other | Conventional therapy |
Primary outcome
Change in Walking ability
Time frame: Baseline , end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)
The walking ability will be assessed using the Walking Index Spinal Cord Injury (WISCI) II which evaluates the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from Spinal Cord Injury (SCI). The WISCI II score ranges from 0 to 20 (0: the individual is unable to walk, 20: the individual walks without assistance or devices)
Change in Balance
Time frame: Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)
The balance will be assessed by the time taken to complete the Timed-Up-and-Go (TUG) test which evaluates mobility and balance.
Change in Gait speed
Time frame: Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)
The gait speed will be assessed by the time taken to complete the 10 meter Walk Test (10mWT) which evaluates walking speed in meters per second over a short duration.
Change in Lower Extremity Motor Score (LEMS)
Time frame: Baseline, mid-training (at 4 weeks), end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)
The Lower Extremity Motor Score (LEMS) evaluates motor function on a scale of 0 (no motor function) to 5 (full motor function) for 5 lower extremity muscle groups with a 50-point maximum (25 per side).
Change in Trunk control
Time frame: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)
The trunk control will be assessed using the Trunk Assessment Scale for Spinal Cord Injury (TASS). The TASS consists of nine sitting tasks without upper-limb support: one task is static, and the other eight tasks are dynamic. Each item is assigned a score of 0-2, 0-4, or 0-6 for a total score of 44, with higher scores indicating better trunk function.
Change in Endurance
Time frame: Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)
Endurance will be assessed by the distance (in meters) walked during the 2-Minute Walk Test (2MWT), which evaluates walking capacity and functional mobility.
Change in Endurance
Time frame: Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)
Endurance will be assessed by the distance (in meters) walked during the 6-Minute Walk Test (6MWT), which evaluates walking capacity and functional mobility.
Change in Level of Exertion
Time frame: Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)
Perceived exertion associated with the walking test (2MWT/6MWT) will be assessed using the Borg Rating of Perceived Exertion Scale, a self-report scale ranging from 0 to 10. A score of 0 indicates no exertion, and 10 indicates maximal exertion. Higher scores represent greater perceived exertion.
Change in Gait pattern
Time frame: Baseline, mid-training (at 4 weeks), end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)
The gait pattern and compensatory movements will be assessed through kinetic and kinematic gait parameters collected using a 3-D gait analysis system. The Gait Deviation Index for SCI (SCI-GDI) will be calculated to evaluate the difference between the patient' gait pattern compared to the reference gait pattern. The SCI-GDI score typically ranges from 0 to 100, with 100 representing a normal gait pattern.
Change in Bladder and Bowel function
Time frame: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)
Bladder and bowel function will be assessed using the International Standards to document Autonomic Function following SCI (ISAFSCI), which identifies which autonomic functions (e.g., bladder, bowel) are intact, impaired, or lost.
Change in Bladder and Bowel function
Time frame: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)
Bowel function will also be assessed using the Neurogenic Bowel Dysfunction score (NBD score), a self-report questionnaire. The total NBD score ranges from 0 to 47, with higher scores indicating more severe dysfunction.
Change in Bone density
Time frame: At baseline and end of treatment (at 8 weeks)
The Bone density will be assessed through analytical control, 24-hour urine, and dual-energy X-ray absorptiometry (DEXA) scan in the spine, hip and knee.
Change in Cardiovascular function
Time frame: At baseline and end of treatment (at 8 weeks)
The cardiovascular function will be asssessed by an arm ergometry test, which is a test that measures the heart's response to physical exertion. The maximum heart rate (HR) will be documented.
Change in Respiratory function
Time frame: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)
The respiratory function will be assessed by a simple spirometry, which is a test that measures the volume of air exhaled in one second (FEV1) and the total volume of air exhaled forcefully (FVC).
Pain reduction
Time frame: From baseline to follow-up (at 2 months after the end of treatment)
The reduction in pain will be assessed using International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) which is used to document the interference of pain with physical and emotional function and sleep, probable pain diagnosis, location, intensity and duration. Each value is scored on a 0 to 10 numerical rating scale, where 0 represents no pain and 10 represents the worst pain imaginable.
Change in Spasticity
Time frame: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after the end of treatment)
The spasticity in the lower limbs will be assessed using both the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) score, which evaluates three types of spastic motor behaviors in SCI patients - clonus, flexor spasms, and extensor spasms, as well as the Modified Ashworth Scale (MAS). SCATS total score (0-9; higher = worse outcome)
Change in Functional independence
Time frame: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after the end of treatment)
The functional independence will be assesed using the Spinal Cord Independence Measure III (SCIM III) which is a patient-reported outcome measure that evaluates three main domains: self-care, respiration and sphincter management, and mobility. The SCIM III score is calculated on a scale of 0-100, with 0 indicating complete dependence and 100 indicating complete independence.
Change in Quality of Life
Time frame: At baseline and end of treatment (at 8 weeks)
Quality of life will be assessed using the 5-level EQ-5D version (EQ-5D-5L), a standardized instrument for measuring generic health status. Ranging from 1 (best possible health) to values less than 0.
Change in Quality of Life
Time frame: At baseline and end of treatment (at 8 weeks)
Emotional well-being will be assessed using the Hospital Anxiety and Depression Scale (HADS), which measures anxiety and depression. Score on HADS subscales (0-21 per subscale; with higher numbers indicating a greater level of anxiety or depression)
Change in Quality of Life
Time frame: At baseline and end of treatment (at 8 weeks)
Motivation will be assessed using the interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). Interest/Enjoyment score on IMI subscale (1-7; where 1 represents "Not at all true" and 7 represents "Very true")
Burden of healthcare professionals
Time frame: At end of treatment (8 weeks)
The burden on healthcare professionals will be assessed using the NASA Task Load Index (NASA-TLX), a self-report questionnaire to assess work load on five 7-point scales. NASA-TLX scores can range from 0 to 100, where a higher score generally indicates a higher workload
Change in Burden of the caregiver
Time frame: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after the end of treatment)
The caregiver burden will be assessed using the Zarit Burden Interview, a 22-item self-report questionnaire which total score ranges from 0 to 88. The higher the value, the higher the caregiver burden.
Change in Direct healthcare costs
Time frame: Baseline (Day 0), end of treatment (8 weeks), and follow-up (16 weeks)
The medical costs including hospitalization days, transportations, specialists consultations, rehabilitation services, emergency room visits, and hospital admissions will be calculated.
Intervention-related costs
Time frame: At the end of treatment (8 weeks)
The costs associated to the rehabilitation sessions, treatment, and equipment during the intervention period will be calculated.
Change in the productivity losses
Time frame: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after the end of treatment)
Variation in indirect costs for patient and caregiver, associated with reduced work capacity, absenteeism, or early retirement, as a result of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lluïsa Montesinos Magraner, Dr principal investigator
Hospital Universitario de Vall d'Hebron
Ana de los Reyes Guzmán, PhD principal investigator
Hospital Nacional de Parapléjicos
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABLE Exoskeleton and Conventional therapy in people with Spinal Cord Injury, run by ABLE Human Motion S.L. at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lluïsa Montesinos Magraner, Dr (+34 620951308, lluisa.montesinos@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Walking ability (time frame: Baseline , end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.