Multinational randomized controlled cross-over trial comparing C-brace to conventional knee ankle foot orthoses with respect to balance, fall risk and activities of daily living in patients with lower limb impairment..

Some patients with paresis/paralysis of the lower extremity due to incomplete
paraplegia, polio/ post-polio syndrome, MS, CVA, CIAP/CIDP, HMSN II, arthritis
or trauma require a *Knee Ankle Foot Orthosis* (hereafter given by its Dutch
acronym *KEVO*) or, in layman*s terms, a *long leg brace*. The problem with
this is that the conventional KEVO *locks* the affected leg during extension
while walking, which leads to an abnormal gait. Amongst other things, this
causes increased energy consumption, pain and reduced mobility. The development
of aids such as orthoses and prostheses has made great progress and in recent
decades, computer-controlled knees have been developed for patients with leg
amputations. More recently this technology has also been used in knee-ankle
orthoses (KEVOs).

Research on these advances has so far been limited to subjective
questionnaires. Ideally, the research would consist of a combination of
objective measurements and subjective questionnaires, in order to assess
improvements in the disorder as well as activities and participation levels
(ICF model) (1). *Disorder* means the pathology of the physiological and mental
properties of the human organism as well as the anatomical properties that
relate to the presence, position and continuity of parts of the human body,
such as a reduction of balance and muscle strength. Activities are the parts of
a person*s actions, such as self-care, standing and walking. Participation
means a person's participation in social life, such as work and hobbies.


Reference:
1. World Health Organisation. International Classification of Functioning,
Disability and Health: ICF; 2001.

The aim of this study is to investigate
1. the extent to which patients who have paresis/non-spastic paralysis of the
lower extremity and who are moderately active experience an improvement in the
(trunk) balance through the use of a computer-controlled KEVO compared to the
conventional KEVO.
2. whether the use of a computer-controlled KEVO in patients with
paresis/non-spastic paralysis of the lower extremity and who are moderately
active leads to a decrease in the number of fall incidents, an increase in the
independence of activities of daily life and improved quality of life compared
to a conventional KEVO?

Prospective international multicentre randomised crossover study

A computer-controlled knee-ankle-foot orthosis called a C-Brace,
knee-ankle-foot orthosis, dynamic long leg brace.

The loads experienced by test subjects participating in this study consist of
a) 10 hours of training by a specialised physiotherapist, spread over 2 weeks,
b) 1-2 hours training by physiotherapist when patients go back to their own
KEVO, c) fitting of experimental orthosis by orthotist 2 hours and d) 8.5 hours
of testing spread over 5 moments over a 43-week period. The patient will wear
the C-brace for a period of 3 months.

Patients suffering loss of strength in a leg and who are mobile with a
knee-ankle-foot orthosis run a low risk of falling. This can be done with
either their own orthosis or with the test orthosis. The risk of falling is
minimised because:
1) The patients participating in the study have had rehabilitation treatment in
the past that was aimed at, amongst other things. safe functioning with a KEVO.
2) They receive a maximum of 10 hours of training during the study to ensure
that they function safely with the trial orthosis. When the patient goes back
to their own KEVO, evaluation and training will be given if necessary. The
orthopaedic instrument maker and the physiotherapist involved are experienced
in treating patients with paresis/paralysis of the lower extremity.
3) The test orthosis will be made in a workshop that has been specifically
approved for the standardised and high-quality manufacture of this orthosis.
4) A risk analysis has been carried out by the manufacturer (see Investigators
Brochure, Section 8). This showed that the risk was acceptable or as low as
reasonably achievable after implementing adequate measures.

The performance of the study is justified to my opinion taking in consideration
the load and/or risks for the patients involved in the study because the
added-value of the KAFO will lead to a significant improvement in the level of
functioning of the participant and patients with impaired functioning of the
lower extremity. The expected added-value will be in accordance with
literature.

SUPPLEMENTARY from 1 July 2020:
To minimize the potential infection risk, patients are requested to wear face
masks/face shields and keep one-and-a-halve metre distance (social distancing)
to other people. If the patient has a high risk profile, the guidelines from
the RIVM are followed. Om het risico op infectie met COVID-19 te minimaliseren,
wordt aan de proefpersoon gevraagd een mondkapje te dragen en anderhalve meter
afstand te houden tot anderen. Mocht de proefpersoon tot de risicogroepen
behoren, dan worden in Hoensbroek de richtlijnen van het RIVM gevolgd om het
risico van infectie zo klein mogelijk te houden door de volgende maatregelen:
During patient visits, every effort will be taken to minimize a potential
infection risk by:
• limiting the number of staff to a minimum,
• providing sufficient protection material to the patients as well as to the
staff as adviced by RIVM.
• minimizing the length of stay necessary for the patients and
• maximizing the distance between patients and staff as much as possible.

In case of increasing health risk or for any other reason, all enrolled
subjects may withdraw from the study at any time.

Therefore, it can be concluded that, given that all mitigation measures
described above are taken, the risks associated with a study visit during the
COVID-19 pandemic are acceptable when weighed against the benefits that this
research can generate for the individual and the population in general.