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Trial registered on ANZCTR


Registration number
ACTRN12619000014156
Ethics application status
Approved
Date submitted
15/12/2018
Date registered
9/01/2019
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a long term training program through a wearable exoskeleton in persons with multiple sclerosis on gait velocity
Scientific title
Effectiveness of a long term training program through a wearable exoskeleton in persons with multiple sclerosis on gait velocity
Secondary ID [1] 296828 0
Nil known
Universal Trial Number (UTN)
U1111-1225-2668
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 310725 0
Condition category
Condition code
Neurological 309420 309420 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 309421 309421 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Maintaining the ability to walk is one of the significant challenges in persons with multiple sclerosis (MS) for keeping an active life style with a good quality. This randomized clinical trial aims to evaluate the effectiveness of a 3 month training program through a wearable exoskeleton in persons with multiple sclerosis (MS) on gait velocity. Subjects in the intervention group will add to the physiotherapy habitual treatment scheduled for the control group, the participation in a progressive gait training program assisted by the exoskeleton “Ekso Bionics” (Europe GmbH, Tullastrasse 80, 79108 Friburgo, Alemania, CE 852.170501, Notified Body & ID: UL, 0843). Ekso® is a powered, wearable robotic lower limb exoskeleton with actuated hips and knees that provides assistance to lower limb segments during movement, dependent on user needs. The programme´s technical content is based on a specific literature review including author´s expertise and field experience. The intervention will consist of twice a week individually supervised sessions assisted by the wearable exoskeleton. The approximate duration of each training session will range between 20-30 minutes. An interval of at least 48 hours between training sessions will be respected. The sessions will include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit exercises. The progression and intensity of the intervention will be adapted to the capacity of each participant (duration, speed, cadence, length of the steps, robotic assistance, etc.) and the total duration of the training will be progressively increased as the participants increase their tolerance. Goals will be adapted in response to illness, injury or physical symptoms. Subjects will wear their own shoes, orthotics and usual technical aids. Training attendance will be recorded every session. The program will be carried out by experienced physiotherapists trained in exoeskeleton driving in ADEMBI (Asociación de Esclerosis Múltiple de Bizkaia: http://www.esclerosismultipleeuskadi.org/adembi/), the association of persons with multiple sclerosis of our territory.
Intervention code [1] 313112 0
Treatment: Devices
Intervention code [2] 313113 0
Rehabilitation
Comparator / control treatment
Subjects in the control group will participate in the physiotherapy sessions provided to all patients in ADEMBI. In this sessions, conventional methods of physiotherapy are provided to control spasticity, maintain articular range, balance and gait. All participants will carry out this sessions (intervention group will add to this sessions the training through the exoesqueleton)
Control group
Active

Outcomes
Primary outcome [1] 308375 0
The primary outcome measure will be the difference in gait speed between intervention and control group assessed by the timed 10 meters walk test at a normal/habitual speed. This test has been validated for persons with multiple sclerosis to assess the capacity to walk. The time spent in performing the test will be measured through photoelectric cells (Polifemo, Microgate, Italy). Participants will wear their own footwear, orthoses and usual technical aids (crutches, canes).
Timepoint [1] 308375 0
Study assessments will be conducted by blinded research staff at ADEMBI at baseline, months 3, 6 and 9.
Primary outcome [2] 308385 0
Quantitative measure of the balance ability through Berg Balance Scale, a 14 items scale that are rated from 0 (cannot perform) to 4 (normal performance). The total score can range from 0 (severely affected balance) to 56 (excellent balance). The items explore the ability to sit, stand, lean, turn and maintain the upright position on one leg and it has acceptable concurrent validity in persons with MS.
Timepoint [2] 308385 0
Study assessments will be conducted by blinded research staff at ADEMBI at baseline, months 3, 6 and 9.
Primary outcome [3] 308386 0
Cognitive evaluation through Montreal Cognitive Assessment. This is a 10-minute cognitive screening tool with high sensitivity and specificity for detecting mild cognitive impairment. The short-term memory recall task involves two learning trials of five nouns and delayed recall after approximately 5 minutes. Visuospatial abilities are assessed using a clock-drawing task and a three-dimensional cube copy. Multiple aspects of executive functions are assessed using an alternation task adapted from the Trail Making B task, a phonemic fluency task, and a two-item verbal abstraction task. Attention, concentration, and working memory are evaluated using a sustained attention task, a serial subtraction task, and digits forward and backward. Language is assessed using a three-item confrontation naming task with low-familiarity animals, repetition of two syntactically complex sentences, and the aforementioned fluency task. Finally, orientation to time and place is evaluated.
Timepoint [3] 308386 0
Study assessments will be conducted by blinded research staff at ADEMBI at baseline, months 3, 6 and 9.
Secondary outcome [1] 354826 0
Fatigue by Modified Fatigue Impact Scale. This scale uses a multidimensional approach with physical, psychological and cognitive clinical outcomes to assess the level of fatigue in activities of daily living and it is recommended by the Multiple Sclerosis Council for Clinical Practice Guidelines.
Timepoint [1] 354826 0
Study assessments will be conducted by blinded research staff at ADEMBI at baseline, as well as at 3, 6 and 9 months from the beginning of the study.
Secondary outcome [2] 354828 0
Functional capacity assessment through Short Physical Performance Battery, a battery of three simple tests: leg strength, gait ability and static balance. The score for each test is given in categorical modality (0–4) based on run time intervals, and the total score will range from 0 (worst) to 12 points (best). A total score of less than 10 points correlates with a high risk of disability and falls. 1 point change in the total score has demonstrated to be of clinical relevance.
Timepoint [2] 354828 0
Study assessments will be conducted by blinded research staff at ADEMBI at baseline, as well as at 3, 6 and 9 months from the beginning of the study.
Secondary outcome [3] 354829 0
Quality of life assessed using EuroQol-5D. This is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The EuroQol-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EuroQol-5D also includes a Visual Analogue Scale where records the patient’s self-rated health on a vertical line with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Timepoint [3] 354829 0
Study assessments will be conducted by blinded research staff at ADEMBI at baseline, as well as at 3, 6 and 9 months from the beginning of the study.
Secondary outcome [4] 354830 0
Inflammatory biomarkers (Tumor Necrosis Factor alpha, Transforming growth factor beta, Interleukin-1 beta, Interleukin-4, Interleukin-6, Interleukin-10) by serum assay through ELISA kit following the manufacture´s instructions.
Timepoint [4] 354830 0
Study assessments will be conducted by blinded research staff at ADEMBI at baseline, as well as at 3, 6 and 9 months from the beginning of the study.
Secondary outcome [5] 365225 0
Number of falls reported by the patients during the study. The reference physiotherapist of each participant will ask weekly during the session if there has been any falls during the current week.
Timepoint [5] 365225 0
Weekly from baseline for 9 months

Eligibility
Key inclusion criteria
Subjects will be considered eligible for the study if all of the following apply: aged greater than or equal to 18 years, diagnosis of primary or secondary progressive MS according to the McDonald criteria, scored on the Expanded Disability Status Scale between 1.5 and 7, scored on the Mini Mental State Examination test greater than or equal to 20 points.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will not be eligible for the study if they have another neurological pathology in addition to MS, have any musculoskeletal disorder that may limit the extension of the hip and knee or plantar flexion of the ankle, have suffered an outbreak of MS during the 3 months prior to the start of the study, not stable pharmacological treatment or that foresees its modification during the study, treatment with botulinum toxin in the 12 weeks prior to the beginning of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size has been calculated to detect a clinically meaningfull change on the gait speed: accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 32 subjects are required in order to detect a difference equal to or greater than 0.1 m/sec speed in the timed 10 meters walk test (SD= 0.16). It has been increased the sample size in an additional 12% (losts during follow-up). The resultant sample size is determinate in 36 subjects, therefore 18 individuals per group (intervention and control group).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/01/2019
Actual
Date of last participant enrolment
Anticipated
21/02/2019
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 21127 0
Spain
State/province [1] 21127 0
Bizkaia

Funding & Sponsors
Funding source category [1] 301402 0
Charities/Societies/Foundations
Name [1] 301402 0
Fundacion Bancaria Bilbao Bizkaia Kutxa
Country [1] 301402 0
Spain
Primary sponsor type
Individual
Name
Ana Rodriguez Larrad
Address
University of the Basque Country
Department of Physiology
Faculty of Medicine and Nursing
Barrio Sarriena s/n,
48940 Leioa, Bizkaia
Country
Spain
Secondary sponsor category [1] 301078 0
None
Name [1] 301078 0
Address [1] 301078 0
Country [1] 301078 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302138 0
Comité de Ética de la Investigación con Medicamentos de Euskadi CEIm-E; Departamento de Salud del Gobierno Vasco
Ethics committee address [1] 302138 0
Ramiro de Maeztu, 10 bajo
01008 Vitoria-Gasteiz
Álava
Ethics committee country [1] 302138 0
Spain
Date submitted for ethics approval [1] 302138 0
02/04/2018
Approval date [1] 302138 0
18/07/2018
Ethics approval number [1] 302138 0
PS2018017
Ethics committee name [2] 302190 0
CEIAB-University of the Basque Country
Ethics committee address [2] 302190 0
Comite Etico de Investigacion Agentes Biologicos
Barrio Sarriena s/n,
48940 Leioa, BI
Ethics committee country [2] 302190 0
Spain
Date submitted for ethics approval [2] 302190 0
27/04/2018
Approval date [2] 302190 0
18/05/2018
Ethics approval number [2] 302190 0
M30_2018_073

Summary
Brief summary
The major aim of this study is to ascertain if a supervised training program through the wearable exoskeleton “Ekso Bionics” in persons with MS carried out in ADEMBI, improves gait speed, functional capacity, cognitive capacity and quality of life, and modifies inflammatory biomarkers when compared with a control group that receives usual care.
The present study is based on a previous pilot study in which we successfully collected preliminary data to accurately demonstrate the feasibility of recruitment, estimate the required sample size for the current trial, confirm the adherence and safety of the intervention, refine the outcome assessments, and optimize the organizational infrastructure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89250 0
Dr Ana Rodriguez Larrad
Address 89250 0
University of the Basque Country
Barrio Sarriena s/n
48940 Leioa, Bizkaia
Country 89250 0
Spain
Phone 89250 0
+34946017925
Fax 89250 0
Email 89250 0
[email protected]
Contact person for public queries
Name 89251 0
ANA RODRIGUEZ LARRAD
Address 89251 0
University of the Basque Country
Barrio Sarriena s/n
48940 Leioa, Bizkaia
Country 89251 0
Spain
Phone 89251 0
+34946017925
Fax 89251 0
Email 89251 0
[email protected]
Contact person for scientific queries
Name 89252 0
Ana Rodriguez Larrad
Address 89252 0
University of the Basque Country
Barrio Sarriena s/n
48940 Leioa, Bizkaia
Country 89252 0
Spain
Phone 89252 0
+34946017925
Fax 89252 0
Email 89252 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants and ADEMBI policy


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn overground robotic gait training program for people with multiple sclerosis: A protocol for a randomized clinical trial.2020https://dx.doi.org/10.3389/fmed.2020.00238
EmbaseOverground Robotic Program Preserves Gait in Individuals With Multiple Sclerosis and Moderate to Severe Impairments: A Randomized Controlled Trial.2021https://dx.doi.org/10.1016/j.apmr.2020.12.002
N.B. These documents automatically identified may not have been verified by the study sponsor.