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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

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1191-3656

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sclerosis Multiplex

Condition category

Condition code

Neurological

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.

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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]

Treatment: Devices

Intervention code [2]

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]

Ashworth scale score

Timepoint [1]