Spinal Cord InjuriesNCT02600013
Locomotor Training With Exoskeleton EKSO-GT in Patients With Incomplete Motor Spinal Cord Injury in a Hospital Setting
An observational study of Spinal Cord Injuries, run by Montecatone Rehabilitation Institute S.p.A. at 1 site in Italy.
Trial summary
The aim of this observational, non-controlled, non-profit study is to describe the responses to rehabilitative training with the robotic exoskeleton EKSO-GT in patients with incomplete motor Spinal Cord Injury (AIS C or D). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2015to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Incomplete motor SCI patients in a setting of inpatient intensive rehabilitation (3rd level hospital)
Who may be able to join
- inpatient consecutive SCI subjects;
- incomplete motor SCI of any etiology, classified as AIS C or D;
- ability to rest the upper limbs on a mobile support (e.g. walker);
- orthostatic exercise well tolerated for at least 60 continuously minutes and regularly exercised; or regular locomotor exercise; or ability of functional walk;
- sufficient range of motion (ROM) of lower limbs joints to achieve a mutual path pattern and allow transition from sitting to vertical position;
- height: minimum 157 cm, maximum 188 cm;
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- maximum weight: 100 kg;
- intertrochanteric maximum distance: 46 cm;
- stable medical condition;
- intact cognitive abilities and full cooperation of the subject;
- research informed consent signed.
Who cannot join
- skin lesions in areas of EKSO contact;
- instability or major deformity of the spine;
- limbs joint instability;
- indication to the use of spinal orthoses;
- presence of uncontrolled spasticity (score > 3 of the Modified Ashworth Scale) in most of the muscle groups of the lower limbs;
- active acute deep vein thrombosis;
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- uncontrolled, severe and recurrent autonomic dysreflexia;
- significant bone fragility;
- recent traumatic and/or pathological bone fractures, significant for the required training;
- limb-length discrepancy for femur length (> 1.3 cm) and leg length (> 1.9 cm);
- neurogenic paraosteoarthropathy (at onset or inflammatory);
- symptomatic orthostatic hypotension;
- cardiopulmonary comorbidities limiting exertion;
- documented psychiatric condition that might hinder the training with EKSO-GT;
- active pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Locomotor Training With the Exoskeleton EKSO-GT in Patients With Incomplete Motor Spinal Cord Injury in a Hospital Setting: an Observational Study
The aim of this observational, non-controlled, non-profit study is to describe the responses to rehabilitative training with the robotic exoskeleton EKSO-GT in patients with incomplete motor Spinal Cord Injury (AIS C or D). Such rehabilitative tool is employed during inpatient intensive rehabilitation in a 3rd level Italian hospital. Safety and tolerability of the device are also assessed and described.
Read the detailed description
The locomotor training, defined as any "therapeutic program aimed at the recovery of walking through intense practice of the task of walking", is a very important part of the treatment plan for patients with locomotor dysfunction of the lower extremities and is aimed at retraining the nervous system, facilitating the recovery of muscle strength, improving balance and voluntary motor coordination. In fact, the majority of gait rehabilitation strategies is based on the concept of plasticity of the Central Nervous System and of "Central Pattern Generator": this plasticity is supposed to be facilitated by early, intensive and specific therapies, able to enhance the natural recovery processes.
The final goal is to help patients regain the highest level of personal autonomy which consequently translates also in a better overall quality of life.
The anthropomorphic robotic exoskeleton EKSO (Ekso Bionics, USA) is designed to assist in upright, weight bearing over ground gait training of people with weakness or paralysis of the lower limbs, due to a disorder, a disease or a neurologic injury. The training with EKSO is possible even in the presence of minimal forearm strength in order to resting to an upfront mobile walker. The device is available on the market for some years and it has recently been introduced in the clinical practice of some Italian rehabilitative centers. Montecatone Rehabilitation Institute acquired the most recent "GT" version of EKSO that enables variable, adaptive assistance.
This observational, longitudinal research study has a descriptive/exploratory intent. It aims at describing the responses to rehabilitative training with the robotic exoskeleton EKSO-GT in a cohort of incomplete motor Spinal Cord Injury patients (AIS C or D), as a rehabilitative tool in a setting of intensive inpatient rehabilitation (3rd level hospital). Safety and tolerability are also assessed and described.
This kind of study is justified by the fact that although the global network of professional users agree on the potential of such "young" technology on rehabilitation outcomes, few are the clinical data published in the scientific literature in relation to its use. It is believed that the results obtained from this study will be useful for the future definition of better protocols of use of the exoskeleton, more specific for the different types of SCI people.
Primary objective: to describe the responses to the robotic over ground gait training with EKSO-GT in an inpatient rehabilitative hospital setting, in people with incomplete motor SCI (AIS C or D). This objective is achieved by means of the administration of walking tests and the assessment of both lower limbs motor function and kinetic and endurance characteristics of walking.
Secondary objectives, description in the same patients' population:
- Safety and tolerability of locomotor training with the EKSO-GT;
- Level of strength and muscle trophism of the patient subjected to the robotic training;
- Any reductions in pain and/or spasticity due to SCI during and after the locomotor training with the EKSO-GT;
- Quality of life and mood status of patients;
- Level of patient satisfaction in relation to the gait training with the EKSO-GT;
- Maintenance of any acquired benefits (follow-up 45 days after the conclusion of the training with the EKSO-GT), with respect to most outcomes taken into account.
All functional assessments are carried out when the patient does not wear the exoskeleton; however, functional gait specific test (10-meter walk test and 6-minutes walk test) are performed when the exoskeleton is worn and when it is not worn only by those patients able to accomplish those gait specific tests in such a way.
For gait specific tests the first evaluation with the exoskeleton worn is programmed to the third robotic rehabilitative session, as the first sessions are necessary for set-up purposes.
Data on the safety and tolerability of the EKSO-GT training are recorded at the beginning and at the end of each session, however a synthesis of safety outcomes will be carried out at predefine time frames.
The training with the EKSO-GT is carried out in addition to the "conventional" locomotor training and in the presence of specifically trained physiotherapists, always under medical supervision.
Patients undergo 12 or 18 rehabilitative EKSO sessions, 2-3 times per week, of max 1 hr each.
- Conditions
- Spinal Cord Injuries
- Keywords
- incomplete motor SCI, robotic gait training, exoskeleton, rehabilitation tool, EKSO-GT
- Medical subject headings
- Spinal Cord Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 10-Meter walk test with EKSO worn
Measured: baseline (session 3, up to 1 week), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks)
Change in 6-Minutes walk test with EKSO worn
Measured: baseline (session 3, up to 1 week), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks)
Change in 10-Meter walk test with EKSO not worn (if able)
Measured: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks)
Change in 6-Minutes walk test with EKSO not worn (if able)
Measured: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks)
Secondary outcomes (26)
Change in 10-Meter walk test
Possible only on those patients able to perform the test without wearing the EKSO during the rehabilitative sessions
Measured: Follow-up: 45 days after EKSO training closing session 12 or 18
Change in 6-Minutes walk test
Possible only on those patients able to perform the test without wearing the EKSO during the rehabilitative sessions
Measured: Follow-up: 45 days after EKSO training closing session (12 or 18)
Change in score of the Walking Index for Spinal Cord Injury, version II (WISCI-II)
Measured: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change in score of the Mobility part of the Spinal Cord Independence Measure scale, version III (SCIM III)
Measured: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change in number of footsteps made when EKSO is worn and actual locomotion is in place
Although measurements are taken on each rehabilitative session, an overall evaluation is carried out also at: baseline (session 3, up to 1 week), session 12 (up to 6 weeks) and session 18 if any (up to 9 weeks)
Measured: Immediately after the end of each rehabilitative session
Change in actual locomotion time when EKSO is worn
Although measurements are taken on each rehabilitative session, an overall evaluation is carried out also at: baseline (session 3, up to 1 week), session 12 (up to 6 weeks) and session 18 if any (up to 9 weeks). This measurement is needed to standardize the progression in walking of each patient, when the EKSO is worn. The formula of the combined, standardized outcome is: "Number of footsteps made when EKSO is worn and actual locomotion is in place" divided by "Actual locomotion time when EKSO is worn"
Measured: Immediately after the end of each rehabilitative session
Change in blood pressure during EKSO rehabilitative sessions
This outcome covers a safety issue and for this reason measurements are taken on each rehabilitative session. However, an overall evaluation is carried out also at: baseline (initial visit), session 12 (up to 6 weeks) and session 18 if any (up to 9 weeks)
Measured: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Change in heart rate during EKSO rehabilitative sessions
This outcome covers a safety issue and for this reason measurements are taken on each rehabilitative session. However, an overall evaluation is carried out also at: baseline (initial visit), session 12 (up to 6 weeks) and session 18 if any (up to 9 weeks)
Measured: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Change in peripheral O2 saturation during each EKSO rehabilitative session
This outcome covers a safety issue and for this reason measurements are taken on each rehabilitative session. However, an overall evaluation is carried out also at: baseline (initial visit), session 12 (up to 6 weeks) and session 18 if any (up to 9 weeks)
Measured: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Number of falls during the whole rehabilitation period with EKSO (worn)
This outcome covers a safety issue and for this reason measurements are taken on each rehabilitative session. However, an overall evaluation is carried out also at: baseline (initial visit), session 12 (up to 6 weeks) and session 18 if any (up to 9 weeks)
Measured: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Onset of pain due to EKSO wearing (NRS scale)
This outcome covers a safety issue and for this reason measurements are taken on each rehabilitative session. However, an overall evaluation is carried out also at: baseline (initial visit), session 12 (up to 6 weeks) and session 18 if any (up to 9 weeks)
Measured: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Onset of pressure ulcers due to EKSO wearing
This outcome covers a safety issue and for this reason measurements are taken on each rehabilitative session. However, an overall evaluation is carried out also at: baseline (initial visit), session 12 (up to 6 weeks) and session 18 if any (up to 9 weeks)
Measured: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Classification of any pressure ulcers emerged due to EKSO wearing, according to the international classification of the European and US National Pressure Ulcer Advisory panels (EPUAP and NPUAP), along with the Pan Pacific Pressure Injury Alliance (PPPIA)
This outcome covers a safety issue and for this reason measurements are taken on each rehabilitative session. However, an overall evaluation is carried out also at: baseline (initial visit), session 12 (up to 6 weeks) and session 18 if any (up to 9 weeks)
Measured: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Onset of musculoskeletal complications due to EKSO rehabilitation
This outcome covers a safety issue and for this reason measurements are taken on each rehabilitative session. However, an overall evaluation is carried out also at: baseline (initial visit), session 12 (up to 6 weeks) and session 18 if any (up to 9 weeks)
Measured: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Onset of other complications due to EKSO rehabilitation
This outcome covers a safety issue and for this reason measurements are taken on each rehabilitative session. However, an overall evaluation is carried out also at: baseline (initial visit), session 12 (up to 6 weeks) and session 18 if any (up to 9 weeks)
Measured: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Change in spasticity (Modified Ashworth Scale)
Measured: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change in pain (ISCI Pain Basic Data Set)
Measured: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change in limbs muscular strength: Total ASIA Lower Extremity Motor Score (LEMS)
Measured: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change in limbs muscular strength: Partial ASIA LEMS score "Lower Extremity Right" (LER)
Measured: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change in limbs muscular strength: Partial ASIA LEMS score "Lower Extremity Left" (LEL)
Measured: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change in lower limbs muscular trophism (circumference of right thigh)
Measured: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change in lower limbs muscular trophism (circumference of left thigh)
Measured: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change of rehabilitative potential: 100 minus the actual Spinal Cord Injury Ability Realization Measurement Index (SCI-ARMI)
Measured: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change of quality of life (ISCI Quality of Life Basic Data Set)
Measured: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change of mood status (POMS questionnaire)
Measured: Baseline (initial visit), session 12 if end of training (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Level of patient satisfaction in the use of the EKSO (ad hoc questionnaire)
Measured: Last EKSO training session (up to 9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montecatone Rehabilitation Institute S.p.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacopo Bonavita, Dir Spinal U, Principal investigator, Montecatone Rehabilitation Institute S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600013
- Sponsor's protocol ID
- CE-15093
- Status last verified
- May 2018
- First submitted
- 4 Nov 2015
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locomotor Training With the Exoskeleton EKSO-GT in Patients With Incomplete Motor Spinal Cord Injury in a Hospital Setting: an Observational Study
- ClinicalTrials.gov ID
- NCT02600013
- Acronym / sponsor ID
- CE-15093
- Conditions
- Spinal Cord Injuries
- Keywords
- incomplete motor SCI, robotic gait training, exoskeleton, rehabilitation tool, EKSO-GT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Montecatone Rehabilitation Institute S.p.A.University, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 9 Nov 2015 (estimated)
- 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.
The aim of this observational, non-controlled, non-profit study is to describe the responses to rehabilitative training with the robotic exoskeleton EKSO-GT in patients with incomplete motor Spinal Cord Injury (AIS C or D). Such rehabilitative tool is employed during inpatient intensive rehabilitation in a 3rd level Italian hospital. Safety and tolerability of the device are also assessed and described.
Detailed description
The locomotor training, defined as any "therapeutic program aimed at the recovery of walking through intense practice of the task of walking", is a very important part of the treatment plan for patients with locomotor dysfunction of the lower extremities and is aimed at retraining the nervous system, facilitating the recovery of muscle strength, improving balance and voluntary motor coordination. In fact, the majority of gait rehabilitation strategies is based on the concept of plasticity of the Central Nervous System and of "Central Pattern Generator": this plasticity is supposed to be facilitated by early, intensive and specific therapies, able to enhance the natural recovery processes.
The final goal is to help patients regain the highest level of personal autonomy which consequently translates also in a better overall quality of life.
The anthropomorphic robotic exoskeleton EKSO (Ekso Bionics, USA) is designed to assist in upright, weight bearing over ground gait training of people with weakness or paralysis of the lower limbs, due to a disorder, a disease or a neurologic injury. The training with EKSO is possible even in the presence of minimal forearm strength in order to resting to an upfront mobile walker. The device is available on the market for some years and it has recently been introduced in the clinical practice of some Italian rehabilitative centers. Montecatone Rehabilitation Institute acquired the most recent "GT" version of EKSO that enables variable, adaptive assistance.
This observational, longitudinal research study has a descriptive/exploratory intent. It aims at describing the responses to rehabilitative training with the robotic exoskeleton EKSO-GT in a cohort of incomplete motor Spinal Cord Injury patients (AIS C or D), as a rehabilitative tool in a setting of intensive inpatient rehabilitation (3rd level hospital). Safety and tolerability are also assessed and described.
This kind of study is justified by the fact that although the global network of professional users agree on the potential of such "young" technology on rehabilitation outcomes, few are the clinical data published in the scientific literature in relation to its use. It is believed that the results obtained from this study will be useful for the future definition of better protocols of use of the exoskeleton, more specific for the different types of SCI people.
Primary objective: to describe the responses to the robotic over ground gait training with EKSO-GT in an inpatient rehabilitative hospital setting, in people with incomplete motor SCI (AIS C or D). This objective is achieved by means of the administration of walking tests and the assessment of both lower limbs motor function and kinetic and endurance characteristics of walking.
Secondary objectives, description in the same patients' population:
- Safety and tolerability of locomotor training with the EKSO-GT;
- Level of strength and muscle trophism of the patient subjected to the robotic training;
- Any reductions in pain and/or spasticity due to SCI during and after the locomotor training with the EKSO-GT;
- Quality of life and mood status of patients;
- Level of patient satisfaction in relation to the gait training with the EKSO-GT;
- Maintenance of any acquired benefits (follow-up 45 days after the conclusion of the training with the EKSO-GT), with respect to most outcomes taken into account.
All functional assessments are carried out when the patient does not wear the exoskeleton; however, functional gait specific test (10-meter walk test and 6-minutes walk test) are performed when the exoskeleton is worn and when it is not worn only by those patients able to accomplish those gait specific tests in such a way.
For gait specific tests the first evaluation with the exoskeleton worn is programmed to the third robotic rehabilitative session, as the first sessions are necessary for set-up purposes.
Data on the safety and tolerability of the EKSO-GT training are recorded at the beginning and at the end of each session, however a synthesis of safety outcomes will be carried out at predefine time frames.
The training with the EKSO-GT is carried out in addition to the "conventional" locomotor training and in the presence of specifically trained physiotherapists, always under medical supervision.
Patients undergo 12 or 18 rehabilitative EKSO sessions, 2-3 times per week, of max 1 hr each.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Incomplete motor SCI patients in a setting of inpatient intensive rehabilitation (3rd level hospital)
Key inclusion criteria (11 listed)
- inpatient consecutive SCI subjects;
- incomplete motor SCI of any etiology, classified as AIS C or D;
- ability to rest the upper limbs on a mobile support (e.g. walker);
- orthostatic exercise well tolerated for at least 60 continuously minutes and regularly exercised; or regular locomotor exercise; or ability of functional walk;
- sufficient range of motion (ROM) of lower limbs joints to achieve a mutual path pattern and allow transition from sitting to vertical position;
Key exclusion criteria (15 listed)
- skin lesions in areas of EKSO contact;
- instability or major deformity of the spine;
- limbs joint instability;
- indication to the use of spinal orthoses;
- presence of uncontrolled spasticity (score > 3 of the Modified Ashworth Scale) in most of the muscle groups of the lower limbs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in 10-Meter walk test with EKSO worn
Time frame: baseline (session 3, up to 1 week), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks)
Change in 6-Minutes walk test with EKSO worn
Time frame: baseline (session 3, up to 1 week), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks)
Change in 10-Meter walk test with EKSO not worn (if able)
Time frame: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks)
Change in 6-Minutes walk test with EKSO not worn (if able)
Time frame: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks)
26 secondary outcomes
Change in 10-Meter walk test
Time frame: Follow-up: 45 days after EKSO training closing session 12 or 18
Change in 6-Minutes walk test
Time frame: Follow-up: 45 days after EKSO training closing session (12 or 18)
Change in score of the Walking Index for Spinal Cord Injury, version II (WISCI-II)
Time frame: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change in score of the Mobility part of the Spinal Cord Independence Measure scale, version III (SCIM III)
Time frame: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change in number of footsteps made when EKSO is worn and actual locomotion is in place
Time frame: Immediately after the end of each rehabilitative session
Change in actual locomotion time when EKSO is worn
Time frame: Immediately after the end of each rehabilitative session
Change in blood pressure during EKSO rehabilitative sessions
Time frame: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Change in heart rate during EKSO rehabilitative sessions
Time frame: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Change in peripheral O2 saturation during each EKSO rehabilitative session
Time frame: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Number of falls during the whole rehabilitation period with EKSO (worn)
Time frame: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Onset of pain due to EKSO wearing (NRS scale)
Time frame: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Onset of pressure ulcers due to EKSO wearing
Time frame: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Classification of any pressure ulcers emerged due to EKSO wearing, according to the international classification of the European and US National Pressure Ulcer Advisory panels (EPUAP and NPUAP), along with the Pan Pacific Pressure Injury Alliance (PPPIA)
Time frame: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Onset of musculoskeletal complications due to EKSO rehabilitation
Time frame: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Onset of other complications due to EKSO rehabilitation
Time frame: Immediately before the beginning of each EKSO rehabilitative session, immediately after the end of each EKSO rehabilitative session
Change in spasticity (Modified Ashworth Scale)
Time frame: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change in pain (ISCI Pain Basic Data Set)
Time frame: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change in limbs muscular strength: Total ASIA Lower Extremity Motor Score (LEMS)
Time frame: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change in limbs muscular strength: Partial ASIA LEMS score "Lower Extremity Right" (LER)
Time frame: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change in limbs muscular strength: Partial ASIA LEMS score "Lower Extremity Left" (LEL)
Time frame: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change in lower limbs muscular trophism (circumference of right thigh)
Time frame: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change in lower limbs muscular trophism (circumference of left thigh)
Time frame: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change of rehabilitative potential: 100 minus the actual Spinal Cord Injury Ability Realization Measurement Index (SCI-ARMI)
Time frame: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change of quality of life (ISCI Quality of Life Basic Data Set)
Time frame: Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Change of mood status (POMS questionnaire)
Time frame: Baseline (initial visit), session 12 if end of training (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session
Level of patient satisfaction in the use of the EKSO (ad hoc questionnaire)
Time frame: Last EKSO training session (up to 9 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
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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. This study is not recruiting at the moment.
Jacopo Bonavita, Dir Spinal U principal investigator
Montecatone Rehabilitation Institute S.p.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by Montecatone Rehabilitation Institute S.p.A. at 1 site in Italy.
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 11 inclusion and 15 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: finished, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 10-Meter walk test with EKSO worn (time frame: baseline (session 3, up to 1 week), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks)). The study lists 4 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 25 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.