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Trial registered on ANZCTR


Registration number
ACTRN12618001760268
Ethics application status
Approved
Date submitted
17/10/2018
Date registered
25/10/2018
Date last updated
25/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Robotic exercises improve function in tetraplegia
Scientific title
Efficacy of upper-limb robotic-assisted exercises in promotion of self-care activities in people with subacute tetraplegia
Secondary ID [1] 296364 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tetraplegia 310099 0
Condition category
Condition code
Neurological 308841 308841 0 0
Other neurological disorders
Injuries and Accidents 308890 308890 0 0
Other injuries and accidents
Musculoskeletal 308891 308891 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
robotic exercise:
upper-limb robotic-assisted exercises done for 20 minutes, 5 days/week, through 6 weeks (Armeo Spring, Hocoma AG, Switzerland), with the assistance of trained occupational therapist
1. Example of the exercise used:
a) balloons: precision game of collecting balloons in space
b) diving in the sea: perception of depth and space
c) fishing: categorising objects in space
2. Exercises during the workhours with 10 minutes of preparation and 20 minutes of actual training, in dedicated therapy area with constant monitoring of occupational therapist, and gradual increase in games complexity.
3. "Armeo" is a robotic machine providing weight-compensation exoskeleton for arm and allowing virtual gaming in three-dimensional workspace and providing assistance to a desired movement. Patient is seated in a wheelchair with the dominant arm and hand attached to the machine arm enabling three-dimensional movements, while trying to execute tasks required by the game, i.e. catching the balloons or evading obstacles. This may improve the functions of the impaired hand and contribute to hand dexterity in daily living tasks.
Intervention code [1] 312696 0
Rehabilitation
Comparator / control treatment
rehabilitation with robotic exercise (test group) vs rehabilitation only as the control (former group gathered afterwards when the robotic machine - treatment which was borrowed was not any more available in the hospital)
Rehabilitation or rehabilitation only: programme of individually-tailored rehabilitation plan with short-term and long-term goals agreed by the multi-professional team (physician, nurse, physiotherapist, occupational therapist, psychologist, social worker, patient and his/her carers, significant others..) using their skills and competences improving patient`s abilities in activity and participation, during the subacute time post injury and with the final goals of successful return and participation in the society.
Rehabilitation only (standard rehabilitation programme) typically consist of: respiratory exercises, verticalization (on tilt-table, in standing frame, with walker, with crutches, with physiotherapist's assistance or independent), strengthening of residual motor strength of non-affected motor groups (active isometric or isotonic exercises) and affected limbs (passive or assisted range of motion and strengthening if possible), balance training in seating, standing and transfering to the wheelchair, propelling of wheelchair indoors and outdoors. Occupational therapist assist patients to learn basic self-care skills in feeding, grooming, dressing, personal hygiene, posture and transfer and advanced use of wheelchair in the society, kitchen use etc, with assessment of rehabilitation aids promoting that goals. Patients may undergo additional hydro-kinesio-therapy in small or bigger pools, sometimes assisted by physiotherapist, or prescribed various forms of electro-therapy i.e. bio-feed-back, or ultrasound or krio-therapy or heat-therapy or mirror-therapy etc. Nursing include skin care, respiratory care, eliminatory functions care and educational activities towards patients and carers. Psychologist provide psychological assistance to patients and his/her significant others, while social worker helps with discharge planning to the community, including peer-support. All these activities may take 3-4 hours of the work-hours/patient and, although individually tailored for every patient given his/her completeness and level of injury as well as age, pre-morbid lifestyle and health, co-morbidities and complications, it is a programme consistent with standard rehabilitation programmes as described in textbooks or guidelines for rehabilitation of spinal cord injury patients.
Control group
Active

Outcomes
Primary outcome [1] 307818 0
Spinal Cord Independence Measure III - subcale for self-care
Timepoint [1] 307818 0
6 weeks training as the timepoint
Secondary outcome [1] 353048 0
motivation
Self-devised questionnaire "SPIN-1" by a series of Q and A devised by psychologist and to assess motivation before and after the time period of the study (intervention in test group), to monitor if these affected the results.
Timepoint [1] 353048 0
6 weeks
The assessment was made before the enrolment and immediately following the completion of intervention (study period) of each participant.
Secondary outcome [2] 353049 0
vulnerability
Self-devised questionnaire "SPIN-1" by a series of Q and A devised by psychologist and to assess vulnerability before and after the time period of the study (intervention in test group), to monitor if these affected the results.
Timepoint [2] 353049 0
6 weeks
The assessment was made before the enrolment and immediately following the completion of intervention (study period) of each participant.

Eligibility
Key inclusion criteria
subacute tetraplegic patients undergoing rehabilitation
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
inability to sit

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



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 20940 0
Croatia
State/province [1] 20940 0

Funding & Sponsors
Funding source category [1] 300967 0
Hospital
Name [1] 300967 0
Special Medical Rehabilitation Hospital
Address [1] 300967 0
Trg slobode 1
42223 Varazdinske Toplice
Croatia
Country [1] 300967 0
Croatia
Primary sponsor type
Hospital
Name
Special Medical Rehabilitation Hospital
Address
Trg slobode 1
42223 Varazdinske Toplice
Croatia
Country
Croatia
Secondary sponsor category [1] 300545 0
None
Name [1] 300545 0
Address [1] 300545 0
Country [1] 300545 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301730 0
Hospital ethics committee
Ethics committee address [1] 301730 0
Special Medical Rehabilitation Hospital
Trg slobode 1
42223 Varazdinske Toplice
Croatia
Ethics committee country [1] 301730 0
Croatia
Date submitted for ethics approval [1] 301730 0
18/11/2016
Approval date [1] 301730 0
18/11/2016
Ethics approval number [1] 301730 0
01-1912/2-2016

Summary
Brief summary
Objective was to investigate the efficacy of upper-limb robotic-assisted exercises in promotion of self-care activities in people with subacute cervical spinal cord injury in National spinal injuries rehabilitation centre, Varaždinske Toplice, Croatia
Test group comprised of 13 people with tetraplegia (C4-C7, AIS A-D) who underwent standard multi-professional rehabilitation programme with the addition of upper-limb robotic-assisted exercises done for 20 minutes, 5 days/week, through 6 weeks (Armeo Spring, Hocoma AG, Switzerland); the Control group comprised of 12 level, completeness and days-post-injury matched individuals undergoing standard rehabilitation programme, without robotic-assisted exercises. Hypothesis: The addition of robotic exercises would improve patients` self- care skills better, measured by SCIM III (Spinal Cord Independence Measure III) subscale in feeding, dressing and grooming.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87918 0
A/Prof Sasa Moslavac
Address 87918 0
Special Medical Rehabilitation Hospital
42223 Varazdinske Toplice
Croatia
Country 87918 0
Croatia
Phone 87918 0
+385 42 630 224
Fax 87918 0
Email 87918 0
sasa.moslavac@sbvzt.hr
Contact person for public queries
Name 87919 0
A/Prof Sasa Moslavac
Address 87919 0
Special Medical Rehabilitation Hospital
42223 Varazdinske Toplice
Croatia
Country 87919 0
Croatia
Phone 87919 0
+385 42 630 224
Fax 87919 0
Email 87919 0
sasa.moslavac@sbvzt.hr
Contact person for scientific queries
Name 87920 0
A/Prof Sasa Moslavac
Address 87920 0
Special Medical Rehabilitation Hospital
42223 Varazdinske Toplice
Croatia
Country 87920 0
Croatia
Phone 87920 0
+385 42 630 224
Fax 87920 0
Email 87920 0
sasa.moslavac@sbvzt.hr

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary