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Trial registered on ANZCTR


Registration number
ACTRN12617000447358
Ethics application status
Approved
Date submitted
18/02/2017
Date registered
27/03/2017
Date last updated
18/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the efficacy of rehabilitation robotics in gait rehabilitation in patients with multiple sclerosis.
Scientific title
Comparison of the efficacy of rehabilitation robotics as the Lokomat and the Exosceleton EKSO GT in gait rehabilitation in patients with multiple sclerosis
Secondary ID [1] 291193 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
multiple sclerosis 302086 0
gait limitations 302087 0
postural control 302088 0
fatigue 302089 0
muscle strength 302090 0
Condition category
Condition code
Neurological 301717 301717 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 301718 301718 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
People with multiple sclerosis will participate in the study.
The main objective of the study is the comparison of effectiveness the gait rehabilitation with the use of a lower body exoskeleton EKSO GT with Variable Assist software extension (EKSO Bionics, Richmond, CA, USA) and Robot-Assisted Treadmill Therapy (Lokomat, Hocoma, Volketswil, Switzerland). The assessment will be undertaken before program and after 3 weeks of training with EKSO GT and Lokomat. All measurement procedures will be performed by members of the research team. Participants who meet eligibility requirements will be randomly divided into group with EKSO (n=18) and group with Lokomat (n=18). Each patient will participate in 15 training sessions with using EKSO GT.
Each patient's training will last 3 weeks, 5 times a week (form Monday to Friday). Time of each training session is - from 45 to 60 minutes.
Robotic gait training in both groups will be conducted by a physiotherapist who is not participating neither in a basic survey nor in a control test. Training parameters for each patient will be individually tailored by the physiotherapist. The duration of each training session will depend on the patient walking capabilities. Participation in the training is confirmed in medical records.
Participants from both groups will implement a standard rehabilitation program.
Physiotherapists who conduct the trainings, are certified EKSO and Lokomat
specialists. Each training session in Ekso GT and Lokomat will be stored in software
and recorded in patient's medical documentation.
Intervention code [1] 297193 0
Treatment: Devices
Intervention code [2] 297194 0
Rehabilitation
Comparator / control treatment
Members of the control group will undergo the training on Robot-Assisted Treadmill Therapy – Lokomat. The gait speed will be adjusted to the patient’s individual abilities. The amount of body weight support will not exceed 10% of patient’s body weight. Lokomat gait training time- 45 to 60 minutes. Number of trainings- 15, 3 weeks (form Monday to Friday). Alongside the treadmill training, the control group will also undergo a daily rehabilitation program, including 90 minutes of excersise therapy.
Control group
Active

Outcomes
Primary outcome [1] 301129 0
Changes in muscular strength assessed by isokinetic dynamometer during knee flexion-extension (Biodex System 4 Pro, Biodex Medical Systems Inc. USA)
Timepoint [1] 301129 0
Baseline, before program and after 3 weeks treatment with Ekso GT or Lokomat
Primary outcome [2] 301130 0
Changes in balance assessed by baropodometric platform (Zebris FDM-S, Zebris Medical GmbH, Germany). Stabilometric evaluation of quiet standing (eyes open/eyes closed), weight bearing during quiet standing
Timepoint [2] 301130 0
Baseline, before program and after 3 weeks treatment with Ekso Gt or Lokomat
Primary outcome [3] 301134 0
Evaluation of the spatial-temporal gait parameters by BTS G-Walk system (BTS Bioengineering).
Timepoint [3] 301134 0
Baseline, before program and after 3 weeks treatment with Ekso Gt or Lokomat
Secondary outcome [1] 331804 0
Changes in gait speed assessed by timed 25-foot walk test (T25FWT)
Timepoint [1] 331804 0
Baseline, before program and after 3 weeks treatment with Ekso Gt or Lokomat
Secondary outcome [2] 331805 0
Changes in muscular strength assessed by isokinetic dynamometer during shoulders internal and external rotation (Biodex System 4 Pro, Biodex Medical Systems Inc. USA)
Timepoint [2] 331805 0
Baseline, before program and after 3 weeks treatment with Ekso Gt or Lokomat
Secondary outcome [3] 331806 0
Fatigue assessed by Fatigue Severity Scale (FSS)
Timepoint [3] 331806 0
Baseline, before program and after 3 weeks treatment with Ekso Gt or Lokomat
Secondary outcome [4] 331807 0
Dynamic balance will be assessed by the Timed Up and Go Test and the choice stepping reaction time test.
Timepoint [4] 331807 0
Baseline, before program and after 3 weeks treatment with Ekso Gt or Lokomat
Secondary outcome [5] 331808 0
Balance assessed via the Berg Balance Scale (BBS)
Timepoint [5] 331808 0
Baseline, before program and after 3 weeks treatment with Ekso Gt or Lokomat

Eligibility
Key inclusion criteria
Participants with Multiple Sclerosis,
Expanded Disability Status Scale (EDSS) 6,0-7,0
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Difference in lower limbs length bigger then 2 cm
Weight above 100 kg
Height lower then 150 cm or above 190 cm
History of significant problems with skin breakdown or current skin breakdown that would prevent subject from wearing the device
Joint contractures of the hip, knee, or ankle that might limit normal ROM during ambulation
Medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe osteoporosis, or severe spasticity)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer generated from an external web-based randomisation service.
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
2-arm trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/04/2017
Actual
7/04/2017
Date of last participant enrolment
Anticipated
23/06/2017
Actual
23/06/2017
Date of last data collection
Anticipated
14/07/2017
Actual
14/07/2017
Sample size
Target
36
Accrual to date
Final
35
Recruitment outside Australia
Country [1] 8675 0
Poland
State/province [1] 8675 0
Podkarpackie

Funding & Sponsors
Funding source category [1] 295638 0
University
Name [1] 295638 0
University of Rzeszow
Country [1] 295638 0
Poland
Funding source category [2] 295667 0
Hospital
Name [2] 295667 0
National MS Rehabilitation Center in Dabek
Country [2] 295667 0
Poland
Primary sponsor type
University
Name
University of Rzeszow
Address
University of Rzeszow
Aleja Rejtana 16c
35-959 Rzeszow
Country
Poland
Secondary sponsor category [1] 294478 0
None
Name [1] 294478 0
Address [1] 294478 0
Country [1] 294478 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296956 0
The Ethical Committee of Regional Medical Chamber in Krakow
Ethics committee address [1] 296956 0
ul. Krupnicza 11a
31-123 Krakow
Ethics committee country [1] 296956 0
Poland
Date submitted for ethics approval [1] 296956 0
10/10/2016
Approval date [1] 296956 0
15/12/2016
Ethics approval number [1] 296956 0
173/KBL/OIL/2015

Summary
Brief summary
The limitation of the possibility of efficient and independent movement is one of the major problems among people with MS. The optimal level of locomotion is also a balance, strength and endurance. They allow the safe and efficient movement. The robots are often used in rehabilitation of people with neurological diseases especially with severe symptoms and significantly limitation ability to walk. So far, only few studies were conducted using the Lokomat in gait rehabilitation among the patients with MS as well as there are a few studies evaluating the effects of gait rehabilitation using the walking robots. There are no studies comparing these two types of robots. The main objective of the study is to compare of effectiveness the gait rehabilitation in patients with MS with the use of two kind of robots: lower body exoskeleton EKSO GT and Assisted Treadmill Therapy (Lokomat). The survey will be conducted in a specialized rehabilitation center. The study will include patients with MS (EDSS 6 do 7). The study will include 36 patients who will be randomly divided into two groups. Study group (n=18) which will practice using Ekso GT and control group which will practice using Lokomat. Both groups will have 15 training sessions during 3 weeks. The time of each training session will last from 45 to 60 minutes. An assessment of the patients will be carried out before the start of the program and after its completion. The gait (speed, cadence), static and dynamic balance, muscle strength of upper and lower extremities and the level of fatigue will be evaluated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72534 0
Dr Mariusz Druzbicki
Address 72534 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 72534 0
Poland
Phone 72534 0
+48178721941
Fax 72534 0
+48178721930
Email 72534 0
[email protected]
Contact person for public queries
Name 72535 0
Mariusz Druzbicki
Address 72535 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 72535 0
Poland
Phone 72535 0
+48178721941
Fax 72535 0
+48178721930
Email 72535 0
[email protected]
Contact person for scientific queries
Name 72536 0
Mariusz Druzbicki
Address 72536 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 72536 0
Poland
Phone 72536 0
+48178721941
Fax 72536 0
+48 8721930
Email 72536 0
[email protected]

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