Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001132235
Ethics application status
Approved
Date submitted
2/03/2018
Date registered
10/07/2018
Date last updated
17/06/2019
Date data sharing statement initially provided
17/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a external skeletal device for the rehabilitation of patients following stroke
Scientific title
Effectiveness of a virtual myoelectric exoskeleton as a rehabilitation system for patients following stroke
Secondary ID [1] 293999 0
SANIDAD 2017 RIS III
Universal Trial Number (UTN)
U1111-1209-1706
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 306511 0
Ischaemic Stroke 307715 0
Haemorrhagic Stroke 307716 0
Condition category
Condition code
Stroke 305622 305622 0 0
Ischaemic
Stroke 307365 307365 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 307366 307366 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm1: virtual myoelectric exoskeleton involving active assisted upper limb movements whilst the patient is immersed in a virtual reality environment that requires the patient to interact with a serious game. The virtual reality system with a serious game used in this platform is an immersive virtual reality (VR) system with two VR environments: one is a kitchen where the aim is to perform functional tasks such as taking a bottle; the other involves a boat with holes that the patient has to close to prevent water entry. These two environments are coupled with the electromyography driven exoesqueleton allowing patients to receive assistance with upper limb movements whilst performing tasks in a realistic virtual environment. In addition patients will receive balance and gait reeducation exercises (e.g. standing over an unstable surface; weight transfer between limbs; treadmill walking with feedback and assistance from physiotherapist). Total intervention time is 50 minutes (30 mins with exoskeleton assisted upper limb reeducation in VR environment, 10 minutes gait reeducation, 10 mins balance re-education).

Arm2: active upper limb movements whilst the patient is exposed to the illusion caused by a mirror box. In addition patients will perform the same movements performed by patients in arm1 with the exoskeleton but with the assistance of a Physiotherapist rather than the exoskeleton. In addition patients will receive balance and gait reeducation exercises. Total intervention time is 50 minutes (30 mins upper limb re-education with mirror illusion and active assisted movements, 10 mins gait reeducation, 10 mins balance re-education)

Arn3: conventional therapy, 50 minutes (30 upper limb re-education involving active and passive movements, 10 minutes gait reeducation, 10 mins balance reeducation).

All interventions will be 50 minutes per day, 5 days a week (Monday to Friday), for 8 weeks. Interventions will be delivered at the Rehabilitation Unit of a large Hospital by Physiotherapists specialised in neurological rehabilitation. Adherence will be measured as days attending treatment.
Intervention code [1] 300272 0
Rehabilitation
Intervention code [2] 301103 0
Treatment: Devices
Comparator / control treatment
50 minutes of conventional Physiotherapy 50 minutes per day, 5 days a week (Monday to Friday), for 8 weeks.. The intervention involves upper limb functional reeducation (active and passive upper limb movements), and balance and gait reeducation (e.g. standing over an unstable surface; weight transfer between limbs; treadmill walking with feedback and assistance from physiotherapist), The interventions will be delivered at the Rehabilitation Unit of a large Hospital by Physiotherapists specialised in neurological rehabilitation. Adherence will be measured as days attending treatment.
Control group
Active

Outcomes
Primary outcome [1] 304984 0
Muscle activation amplitude of deltoid during upper limb movements described in the Fugl Meyer scale. Fugl Meyer is a scale normally used to measure upper limb function, however sometimes the scale is not sensitive enough to detect changes. Surface electromyography measurement during this test should provided more detailed information about muscle function recovery.
Timepoint [1] 304984 0
Baseline and immediately after intervention is completed (8 weeks)
Primary outcome [2] 304988 0
Muscle activation amplitude of surface electromyography signal of biceps during upper limb movements described in the Fugl Meyer scale.
Timepoint [2] 304988 0
Baseline and immediately after intervention is completed (8 weeks)
Primary outcome [3] 306338 0
intermuscular coordination (using surface electromyography) of deltoid,
Timepoint [3] 306338 0
Baseline and immediately after intervention is completed (8 weeks)
Secondary outcome [1] 343810 0
Upper limb Function (International Classification of Function ICF) using Fulg-Meyer test.
Timepoint [1] 343810 0
Baseline and immediately after intervention is complete (8 weeks)
Secondary outcome [2] 346405 0
Upper limb Function and Activity (ICF) using Action research arm test. This is a composite outcome measure.
Timepoint [2] 346405 0
Baseline and immediately after intervention is complete (8 weeks)
Secondary outcome [3] 346406 0
Upper limb Activity (ICF) using Wolf-motor function test.
Timepoint [3] 346406 0
Baseline and immediately after intervention is complete (8 weeks)
Secondary outcome [4] 346407 0
Individual Quality of Life using SEIQLoL questionnaire.
Timepoint [4] 346407 0
Baseline and immediately after intervention is complete (8 weeks)
Secondary outcome [5] 346408 0
Spasticity using Asworth scale.
Timepoint [5] 346408 0
Baseline and immediately after intervention is complete (8 weeks)
Secondary outcome [6] 348446 0
Shoulder range of movement.using Vicon 3D motion tracking system.
Timepoint [6] 348446 0
Baseline and immediately after intervention is completed (8 weeks)
Secondary outcome [7] 348447 0
Elbow range of movement .using Vicon 3D motion tracking system.
Timepoint [7] 348447 0
Baseline and immediately after intervention is completed (8 weeks)
Secondary outcome [8] 348448 0
Wrist range of movement. using Vicon 3D motion tracking system.
Timepoint [8] 348448 0
Baseline and immediately after intervention is completed (8 weeks)
Secondary outcome [9] 348449 0
Finger range of movement.using Vicon 3D motion tracking system.
Timepoint [9] 348449 0
Baseline and immediately after intervention is completed (8 weeks)
Secondary outcome [10] 348450 0
Muscle activation amplitude of surface electromyography signal of triceps during upper limb movements described in the Fugl Meyer scale. Note this is a primary outcome measure.
Timepoint [10] 348450 0
Baseline and immediately after intervention is completed (8 weeks)
Secondary outcome [11] 348451 0
Muscle activation amplitude of surface electromyography signal of infraspinatus,during upper limb movements described in the Fugl Meyer scale. Note this is a primary outcome measure.
Timepoint [11] 348451 0
Baseline and immediately after intervention is completed (8 weeks)
Secondary outcome [12] 348452 0
Muscle activation amplitude of surface electromyography signal of flexor carpi radialis longus during upper limb movements described in the Fugl Meyer scale. Note this is a primary outcome measure.
Timepoint [12] 348452 0
Baseline and immediately after intervention is completed (8 weeks)
Secondary outcome [13] 348453 0
Muscle activation amplitude of surface electromyography signal of flexor digitorum superficialis during upper limb movements described in the Fugl Meyer scale.Note this is a primary outcome measure.
Timepoint [13] 348453 0
Baseline and immediately after intervention is completed (8 weeks)
Secondary outcome [14] 348454 0
Intermuscular coordination (using surface electromyography) of biceps
Timepoint [14] 348454 0
Baseline and immediately after intervention is completed (8 weeks)
Secondary outcome [15] 348456 0
Intermuscular coordination (using surface electromyography) of triceps
Timepoint [15] 348456 0
Baseline and immediately after intervention is completed (8 weeks)
Secondary outcome [16] 348457 0
Intermuscular coordination (using surface electromyography) of infraspinatus
Timepoint [16] 348457 0
Baseline and immediately after intervention is completed (8 weeks)
Secondary outcome [17] 348458 0
Intermuscular coordination (using surface electromyography) of flexor carpi radialis longus,
Timepoint [17] 348458 0
Baseline and immediately after intervention is completed (8 weeks)
Secondary outcome [18] 348459 0
Intermuscular coordination (using surface electromyography) of flexor digitorum superficialis
Timepoint [18] 348459 0
Baseline and immediately after intervention is completed (8 weeks)

Eligibility
Key inclusion criteria
- Patients presenting with an ischemic or haemorrhagic stroke
- Minimum of 2 weeks after the stroke
- Be able to give consent to participate in the study
- Not being able to clean and to dress themselves
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cerebellar syndrome or bilateral motor deficit
- Significant cognitive deficit that impairs comprehension or understanding of the treatment
- Other medical problems that impede the implementation of the treatment
- Spasticity equal or greater than 3 in the Asworth scale.

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)
Computer generated simple randomisation
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
8 participants per groups will be recruited (24 in total). This is a pilot study that will allow the quantification of the necessary sample size to test the effectiveness of the interventions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2019
Actual
Date of last participant enrolment
Anticipated
6/04/2020
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 9638 0
Spain
State/province [1] 9638 0
Bizkaia

Funding & Sponsors
Funding source category [1] 298627 0
Government body
Name [1] 298627 0
Basque Country Government
Country [1] 298627 0
Spain
Primary sponsor type
Individual
Name
Ana Bengoetxea Arrese
Address
Biocruces Institute
Cruces Plaza, 48903 Barakaldo, Bizkaia
Country
Spain
Secondary sponsor category [1] 297792 0
None
Name [1] 297792 0
Address [1] 297792 0
Country [1] 297792 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299587 0
CEIC comunidad autónoma del País Vasco
Ethics committee address [1] 299587 0
Departamento de Salud del Gobierno Vasco
Sebastián,nº 1. Vitoria 01010
Ethics committee country [1] 299587 0
Spain
Date submitted for ethics approval [1] 299587 0
02/06/2017
Approval date [1] 299587 0
27/09/2017
Ethics approval number [1] 299587 0
2017056(PS)
Ethics committee name [2] 299787 0
CEIC comunidad autónoma del País Vasco
Ethics committee address [2] 299787 0
Departamento de Salud del Gobierno Vasco
Sebastián,nº 1. Vitoria 01010
Ethics committee country [2] 299787 0
Date submitted for ethics approval [2] 299787 0
02/06/2017
Approval date [2] 299787 0
27/09/2017
Ethics approval number [2] 299787 0
2017056(PS)

Summary
Brief summary
This study will test the effectiveness of an exoskeleton to treat patients that have suffered a STROKE in the acute stage. Patients will be randomly allocated to three groups:

Arm1: virtual myoelectric exoskeleton involving active assisted upper limb movements whilst patient is immersed in a virtual reality environment. that requires the patient to interact with a serious game. In addition patients will receive conventional physiotherapy..

Arm2: active upper limb movements whilst the patient is exposed to the illusion caused by a mirror box. In addition patients will perform the same movements performed by patients in arm1 with the exoskeleton but with the assistance of a Physiotherapist rather than the exoskeleton.

Arn3: conventional therapy.

All interventions will be 50 minutes per day, 5 days a week (Monday to Friday), for 8 weeks.. Interventions will be delivered at the Rehabilitation Unit of a large Hospital by Physiotherapists specialised in neurological rehabilitation. Adherence will be measured as days attending treatment. The effectiveness of the interventions will be measured using several clinical scales, movement of the upper limb and muscle activity of the upper limb. It is hypothesised that patients in arm1 will experience a greater improvement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80934 0
Mr Raul Zaballa
Address 80934 0
Department of Physiology
Faculty of Medicine and Odontology
University of the Basque Country
Barrio Sarriena, s/n
Leioa | 48940

Country 80934 0
Spain
Phone 80934 0
+34 9460185085
Fax 80934 0
Email 80934 0
[email protected]
Contact person for public queries
Name 80935 0
Miss Leire Santisteban
Address 80935 0
Department of Physiology
Faculty of Medicine and Odontology
University of the Basque Country
Barrio Sarriena, s/n
Leioa | 48940
Country 80935 0
Spain
Phone 80935 0
+34 9460185085
Fax 80935 0
Email 80935 0
[email protected]
Contact person for scientific queries
Name 80936 0
Miss Leire Santisteban
Address 80936 0
Department of Physiology
Faculty of Medicine and Odontology
University of the Basque Country
Barrio Sarriena, s/n
Leioa | 48940
Country 80936 0
Spain
Phone 80936 0
+34 9460185085
Fax 80936 0
Email 80936 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.