Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001228370
Ethics application status
Approved
Date submitted
14/02/2017
Date registered
23/08/2017
Date last updated
23/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of parametric and clinical effects of passive robotic rehabilitation in multiple sclerosis, combined with selective magnetic stimulation of sensorimotor areas of Rolandic fissure and electrostimulation of peripheral, anatomically associated neuro-cutaneous and muscular units
Scientific title
Assessment of parametric and clinical effects of passive robotic rehabilitation in multiple sclerosis, combined with selective magnetic stimulation of sensorimotor areas of Rolandic fissure and electrostimulation of peripheral, anatomically associated neuro-cutaneous and muscular units
Secondary ID [1] 290933 0
None
Universal Trial Number (UTN)
U1111-1191-3656
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sclerosis Multiplex 301546 0
Condition category
Condition code
Neurological 301265 301265 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MAX system (the robotic exoskeleton): Connected system for passive physical therapy, brain magnetostimulation and body's 3d electrotherapy. The process bases on three paralell therapy activities and takes place simultaneusly during three elements therapy session.

1. Selective transversal magnetic stimulation (Rolland sulcus).
Contralatteral electromagnetic coil is aimed on specific part of patient's head.

2. Body's 16 electrodes TNS - 3d electrostimulation.
This process bases on adhesive gel electrodes connected to specific maker places over patient's body (both limbs and trunk).

3. Robotic passive limbs rehabilitation. Two motion programs for upper limbs and one program for lower limbs.
Motorized exoskeleton consisting of human body frame with mechanically driven sockets for each limb, trunk and head. The whole frame is built in a way to most precisely mimic human position and range of motion. The set of electromotors forces disabled parts of patient's body to conduct passive movement it is unable to make by itself.

The process is conducted by a physician - a rehabilitation specialist. The whole procedure bases on the use of an exoskeleton contolled by computer and custom made software. Computer controls all three elements of therapy, coordinating the work of exoskeleton, TNS devices and magnetotherapy equipment.

------------------

Duration of a treatment session - approx. 60 min (once a day for 10 days from Monday to Friday in a rehabilitation clinic in Cieszyn, Poland).

The Sclerosis Multiplex group consisted of 56 patients, 15 men and 41 women, mean age 46.7 +/- 1.94 years. The average time between diagnosis and enrollment to this rehabilitation programme was 12.5 +/- 1.52 years (the longest period was 33 years, the shortest 2 years). Before this rehabilitation programme, 8 people did not participate in any medical programme, the rest did (mainly with Betaferon and Copaxone).

This general (SM) group was randomly divided into two subgroups:

(SM) (1) consisted of 28 people, 7 men and 21 women, mean age 45.85 +/- 1.94 years (50.40 +/- 5.88 for men and 44.05 +/- 1.96 years for women). The average time between diagnosis and enrollment to this rehabilitation programme was 17.39 +/- 1.63 years (the longest period was 33 years, the shortest 5 years). They were treated using "MAX" therapy system.
Mechanical therapy consisted of 100 flexion-extension, 100 abduction-adduction repetitions in shoulder joints and 100 abduction-adduction repetitions in hip joints using MAX system (the robotic exoskeleton).
What took place at the same time, was 3-D electro-stimulation (TENS 12mA / 10Hz / 55 min) and transcranial magnetic stimulation (1mT / 10Hz / 55 min).

(SM) (2) consisted of 28 people, 8 men and 20 women, mean age 41.7 +/- 2.1 for women and 52.5 +/- 2.4 years for men. The average time between diagnosis and enrollment to this rehabilitation programme was 15.8 years. They were treated with magnetotherapy (head: 1mT / 10Hz / 20min), TENS (left and right hand: 12mA / 10Hz / 20 min) and PNF kinesiotherapy (adduction/abduction patterns for upper and lower extremities, chopping, lifting, bilateral patterns for upper extremities, trunk stimulation : erection, elongation, rotation, balancing - 25 min).
This group didn't use "MAX" therapy system (the robotic exoskeleton)..
Intervention code [1] 296804 0
Treatment: Devices
Intervention code [2] 296805 0
Rehabilitation
Comparator / control treatment
Control group (n = 28) consisted of healthy volunteers, (in 46.4% of white-collar workers and in 43.6% of blue-collar workers), including 16 women (57.7%) aged 44.05 +/- 1.96 and 12 men [42.3%] aged 47.83 +/- 3.52.
Mean age: 45.04 +/- 1.91, mean BMI (23.87). Participants declared to have had no injuries, surgeries or addictions. They were also not using any drugs or orthoses.

Healthy people acted as markers defining motorical, perceptual etc. characteristics of a typical person without SM.
They were examined using: ECG, RR, basic chemical blood parameters, limb electrodiagnosis, limb magnetodiagnosis and classic interactive neurological tests (e.g. BDI, Rankin's scale), postrometric tests (quadroscopic pictures, podoscopic pictures, accelerometro-tensometric balance assesment).

The control group received no therapy sessions.
Control group
Active

Outcomes
Primary outcome [1] 300679 0
Ashworth scale score
Timepoint [1] 300679 0
Baseline, after the first and the tenth treatment session.
Primary outcome [2] 301084 0
SFTR method score
Timepoint [2] 301084 0
Baseline, after the first and the tenth treatment session.
Primary outcome [3] 301085 0
Posturometric changes (assessed using contour markers)
Timepoint [3] 301085 0
Baseline, after the first and the tenth treatment session.
Secondary outcome [1] 330598 0
Magnetometric changes (using magnetometry)
Timepoint [1] 330598 0
Baseline, after the first and the tenth treatment session.
Secondary outcome [2] 331688 0
Changes in electroresistance graphs.
Measured through electroresistance and electroresistantial tomography tests.
Timepoint [2] 331688 0
Baseline, after the first and the tenth treatment session.
Secondary outcome [3] 331689 0
Changes in finger plethysmography.
Timepoint [3] 331689 0
Baseline, after the first and the tenth treatment session.

Eligibility
Key inclusion criteria
Patients' main condition was sclerosis multiplex.

For the reference group of healthy people, there were no criteria beyond the fact they did not suffer from SM.
Minimum age
16 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with SM who had SM seizure at that timepoint.

Oncological patients.

Epilepsis.

Systemic diseases (RA, SLE, MCTD, vasculitis etc).

Tuberculosis and other contagious diseases.

Coronar insufficiency (infarct), ventricular arrythmia.

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)
Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Two groups of patients and one group of healthy people underwent therapy. The groups and parametric division was descibed in previous part of the form.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Average with error margin, T-student test, Pearson correlation test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/05/2014
Date of last participant enrolment
Anticipated
Actual
15/06/2014
Date of last data collection
Anticipated
Actual
25/01/2015
Sample size
Target
70
Accrual to date
Final
56
Recruitment outside Australia
Country [1] 8578 0
Poland
State/province [1] 8578 0
Silesia

Funding & Sponsors
Funding source category [1] 295474 0
Self funded/Unfunded
Name [1] 295474 0
Andrzej Dyszkiewicz
Country [1] 295474 0
Poland
Primary sponsor type
Individual
Name
Andrzej Dyszkiewicz
Address
LABIOT
Biotechnology Laboratory
Gozdzikow 2
43-400 Cieszyn, POLAND
Country
Poland
Secondary sponsor category [1] 294297 0
None
Name [1] 294297 0
N/A
Address [1] 294297 0
N/A
Country [1] 294297 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296940 0
Bioethics Comitee of the Academy of Physical Education in Katowice, Poland
Ethics committee address [1] 296940 0
Mikolowska 72A
Katowice, Poland
Ethics committee country [1] 296940 0
Poland
Date submitted for ethics approval [1] 296940 0
09/05/2012
Approval date [1] 296940 0
21/11/2013
Ethics approval number [1] 296940 0
3/1/2013

Summary
Brief summary
The aim of the study was to assess parametric and clinical effects of a new therapy system dedicated for SM patients, that combines passive robotic rehabilitation with selective magnetic stimulation and electrostimulation, and to compare it with the effects of conventional physiotherapy in SM.

Control group K (n = 28) consisted of healthy volunteers (in 46.4% of mental and
in 43.6% of physical workers), including 16 women (57.7%, mean age 44.05 ± 1.96) and 12 men (42.3%; mean age 47.83 ± 3.52), the group's mean BMI was 23.87.
The volunteers used no medications or orthotics. They also had no injuries, surgeries or addictions in their medical records.
The control group received no treatment, but was examined in order to obtain a general profile of a healthy subject that later served for comparisons with pre- and post-treatment results in trial SM groups 1 and 2.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 71426 0
Dr Andrzej Dyszkiewicz
Address 71426 0
LABIOT
Biotechnology Laboratory
Gozdzikow 2,
43-400 Cieszyn
Poland
Country 71426 0
Poland
Phone 71426 0
+48 33 8580588
Fax 71426 0
Email 71426 0
[email protected]
Contact person for public queries
Name 71427 0
Dr Andrzej Dyszkiewicz
Address 71427 0
LABIOT
Biotechnology Laboratory
Gozdzikow 2,
43-400 Cieszyn
Poland
Country 71427 0
Poland
Phone 71427 0
+48 33 8580588
Fax 71427 0
Email 71427 0
[email protected]
Contact person for scientific queries
Name 71428 0
Dr Andrzej Dyszkiewicz
Address 71428 0
LABIOT
Biotechnology Laboratory
Gozdzikow 2,
43-400 Cieszyn
Poland
Country 71428 0
Poland
Phone 71428 0
+48 33 8580588
Fax 71428 0
Email 71428 0
[email protected]

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No Supporting Document Provided



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