Effectiveness of a Powered Exoskeleton Combined With FES for Patients With Chronic SCI: a RCT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMario Widmer
About this trial
While there are a number of prospective studies evaluating powered exoskeletons in SCI patients, to date, not a single well-designed, randomized clinical trial has been published. However, there is evidence for beneficial effects of over-ground exoskeleton therapy on walking function post-intervention from a meta-analysis on non-randomized, uncontrolled studies. Functional electrical stimulation (FES), on the other hand, is a common and established method for the rehabilitation of persons with SCI and has been demonstrated to be beneficial in, e.g., improving muscle force, power output and endurance.
Combining FES and overground robotic therapy within the same therapy session could potentially merge and potentiate the effects of each separate treatment, making it a very powerful and efficient therapy method. Up to date, however, comparative studies evaluating benefits of this combined approach (i.e., powered exoskeleton and FES) to robotic therapy without FES are missing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
chronic, incomplete SCI (> 1 year, AIS B-D)
traumatic or non-traumatic lesion
capacity to stand up and perform a 10MWT with or without medical aids
partially wheelchair dependent
Disqualifiers
Exoskeleton device related contraindications: > 100 kg body weight; Body height: < 155 cm or > 190 cm; pelvic width: > 46 cm
orthopedic limitations (acute fractures of the lower limb)
contractures
heterotrophic ossification
Trial design
Design model
Parallel
Treatments tested in this trial
Ekso (EksoNR, Ekso Bionics)
DeviceThe EksoNR is a powered exoskeleton designed to be used in a rehabilitation setting. The device meets the provision of the Council Directive 93/42/EEC concerning medical devices and is used for gait training in neurorehabilitation.
FES (RehaMove2, Hasomed)
DeviceRehaMove 2 sends electrical impulses via electrodes to nerves to evoke muscle contraction. The device meets the provision of the Council Directive 93/42/EEC concerning medical devices.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Ekso and FESExperimental treatment 2 interventions
Group B: Ekso without FESActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
change in preferred walking speed from baseline (Visit 1) to post-training (Visit 2) as measured by using the 10MWT
The 10MWT is a quantitative measurement of lower extremity function. Patients are instructed to walk 10 meters at their preferred speed. Time is measured while the individual walks the set distance (10 meters). The distance covered is divided by the time it took the individual to walk that distance.
Time frame
within 3 days post-trainingSecondary outcomes
1
change from baseline (Visit 1) in preferred walking speed, measured by the 10MWT, at Visit 3
The 10MWT is a quantitative measurement of lower extremity function. Patients are instructed to walk 10 meters at their preferred speed. Time is measured while the individual walks the set distance (10 meters). The distance covered is divided by the time it took the individual to walk that distance.
Time frame
3 months post intervention2
Changes from baseline at Visit 2 and Visit 3 in maximal walking speed measured by the 10MWT
The 10MWT is a quantitative measurement of lower extremity function. Patients are instructed to walk 10 meters at their preferred speed. Time is measured while the individual walks the set distance (10 meters). The distance covered is divided by the time it took the individual to walk that distance.
Time frame
within 3 days post-training, 3 months post intervention3
Changes from baseline at Visit 2 and Visit 3 in gait function as measured by the Walking Index for Spinal Cord Injury II (WISCI II)
WISCI is an ordinal scale that is used in clinical trials as a tool to asses walking function. It captures the extent and nature of assistance a person with SCI requires to walk. This assessment index includes a rank ordering along a dimension of impairment, from the level of most severe impairment (level 0) to least severe impairment (level 20). The level is based on the use of devices, braces and physical assistance of one or more persons. The ranking of severity is based on the severity of impairment and not on functional independence in the environment.
Time frame
within 3 days post-training, 3 months post intervention4
Changes from baseline at Visit 2 and Visit 3 in endurance as measured by the 6 Minute Walk Test (6mWT)
The 6mWT is a sub-maximal test that is used as a global and easy indicator of the loco-motor performance. Individuals are instructed to walk as far as possible during 6 minutes, taking rests whenever required. The distance covered and the number/time of rests required are recorded.
Time frame
within 3 days post-training, 3 months post interventionOther outcomes
1
Participant characteristics
Participant characteristics will be collected according to the International SCI Core Data Set.
Time frame
3 months post interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mario Widmer
Lead sponsor
Swiss Paraplegic Research, Nottwil
Sponsor institution
Source ClinicalTrials.gov