Clinical trial NCT04173975: Validation of the Efficacy and Usability of the BELK Orthosis Knee Module in a Neurological Setting (BELK@CCP)
Official title: Validation of the Efficacy and Usability of the BELK Orthosis Knee Module in a Neurological Setting
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Instability
Neuromuscular Diseases
Central Nervous System Diseases
Stroke
Lead sponsor: Casa di Cura Privata del Policlinico SpA
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will receive a 6-week training program in a clinical setting in add-on to the standard neuro-rehabilitation treatment.

The add-on rehabilitation training will be focused on lower limb with specific activities for knee instability, and will comprise 3 weeks using the BELK orthosis knee module and 3 weeks without any orthosis.
Primary purpose: TREATMENT

Brief summary: This present study will be devoted to the first clinical study on the efficacy of the BELK system in enhancing mobility and improve the knee rehabilitation process in people with NeuroMuscular Diseases (NMD) and Central Nervous System (CNS) disorders with knee instability that implies deficit in gait and in locomotion during ADL.

Participants will receive a 6-week training program (3 weeks with the BELK orthosis knee module) in a clinical setting in add-on to the standard neuro-rehabilitation treatment. Gait analysis and Instrumental Test will be performed every week till the end of the six-week training period while the Clinical Scales and Questionnaires will be performed after three weeks and at the end of the training period. Finally, additional outcome measures comprise the scores on the System Usability Scale (SUS) to evaluate the hardware and the Software Usability Measurement Inventory (SUMI) to evaluate the software of the BELK orthosis. These two measures will be administrated at the end of training with Belk orthosis, to rate patients' and operators' (e.g., physical therapist, medical doctors) satisfaction.

During 2018, the company GOGOA (www.gogoa.eu), specialized in design, manufacturing and commercialization of Robotic Assisted Rehabilitation (RAR) systems, has developed a first prototype of the BELK system, a powered wearable robotic device that can be used for knee rehabilitation, in the sub-acute phase of knee injuries. As BELK is a wearable device, it can be used both, by the physiotherapist in the rehabilitation centers, improving the knee rehabilitation process and increasing patients' comfort, and accelerating their rehabilitation process.

Casa di Cura del Policlinico (CCP https://www.ccppdezza.it/en/) is a fully integrated multi-specialty clinical center aiming at providing both inpatient and outpatient services mainly directed to neurological patients. The Center is constituted as a Department of Neuro-rehabilitation Sciences, accredited by the Italian National Health System, and economically supported by Regione Lombardia. CCP offers to chronic neurological patients the highest comprehensive standards of care in a comfortable environment, through a multidisciplinary patient management approach organized around a core rehabilitation program.

Detailed description: The study design comprises a clinical study aimed at assessing efficacy of the BELK orthosis knee module on management of instability of the knee in 15 adults who have NMD or a CNS disorder. Participants will receive a 6-week training program (3 weeks with the BELK orthosis knee module) in a clinical setting in add-on at the standard neurorehabilitation treatment.

The add-on rehabilitation training will be focused on lower limb with specific activities for knee instability, and will comprise 3 weeks using the BELK orthosis knee module and 3 weeks without any orthosis. The activities will concern both physical training (e.g., locomotion task, balance exercise, muscle reinforcement, proprioceptive task) and occupational treatment tasks (e.g., transferring/mobility, meal preparation, house-working).

This clinical study will be a Randomized Control Trial (RCT) crossover longitudinal.

The clinical trial will be split in the following phases :

* Recruitment. Subjects admitted to CCP Neurorehabilitation unit will be recruited after considering inclusion and exclusion criteria through clinical history and medical visit.
* Randomization. Enrolled participants will be randomly allocated (per 2 blocked randomization lists, generated electronically by www.random.org) into the BELK assisted group (Group A) or the control group (Group B).
* Clinical, instrumental and questionnaires assessment at T0 (baseline)
* Rehabilitation Treatment (first block) three weeks period, all the patients will perform rehabilitation training. The patients allocated in Group A will perform the training wearing the BELK device while patients allocated in Group B will perform the same exercise without any exoskeleton.
* Clinical, instrumental and questionnaires assessment at T1 (crossover)
* Rehabilitation Treatment (second block) three weeks period, all the patients will perform rehabilitation training. The patients allocated in Group B will perform the training wearing the BELK device while patients allocated in Group A will perform the same exercise without any exoskeleton.
* Clinical, instrumental, questionnaires and usability assessment at T2 (final)
* Additional Instrumental Test will be performed after the first and the second week of each rehabilitation treatment block (i.e., T01, T02, T11, T12).

Instrumental Test consist of:

* Bio-mechanical performance (gait kinematics/kinetics analysis),
* Surface electromyography for knee functional evaluation (EMG),
* 6-minute walking test (6mWT),
* Baseline assessments uptake (VO2),
* Hearth rate (HR),
* Breathing frequency (BF),
* Timed Up and Go Test (TUG),
* Stair Climb Test (SCT).

Clinical scales consist of:

* Functional Independence Measure scale (FIM),
* Functional Ambulation category scale (FAC),
* lower-leg Ashworth scale (sum of score for hip, knee and ankle) (AS),
* Mini Balance Evaluation Systems Test (Mini-Best),
* Motricity Index (MI),
* Self-reported perceived effort (CR-10 Borg).

Questionnaires consist of:

* International Knee Documentation Committee subjective knee evaluation form (IKDC),
* Knee Outcome Survey Activity of Daily Living (KOS ADL) and health-related quality of life (SF-36).

Eligibility criteria: Inclusion Criteria:

* Age: 30 - 85
* Sex: males and females
* Diagnosis of Neuromuscular diseases (NMD) or central nervous system (CNS) disorder with knee instability conditioning gait
* Functional Ambulation Categories (FAC) \> 3
* Mini Mental State Examination (MMSE) \> 24
* Ability to walk at least 10 meters alone or with maximum 1 person assistance

Exclusion Criteria:

* Bilateral impairment of the knees
* Knee implant
* Lower extremity amputation
* Severe sensorial impairment of the lower limbs
* Legal blindness or severe visual impairment
* Pacemakers or metal implants
* Refusal to give informed consent

Primary outcomes:
measure: Change in walking velocity
timeFrame: Before and Immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
measure: Change in Gait Profile Score
timeFrame: Before and Immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
Secondary outcomes:
measure: Change in 6-minute walking test (6MWT)
timeFrame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
measure: Change in joint force
timeFrame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
measure: Change in Surface electromyography (sEMG)
timeFrame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
measure: Change in energy cost of walking
timeFrame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
measure: Change in Stair Climb Test (SCT)
timeFrame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
measure: Change in Timed Up and Go test (TUG)
timeFrame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
measure: Change in Short Form Survey Instrument (SF36)
timeFrame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
measure: Change in International Knee Documentation Committee (IKDC) Questionnaire
timeFrame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
measure: Change in Knee Outcome Survey (KOS)
timeFrame: Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)
measure: System Usability Scale (SUS)
timeFrame: Immediately after the rehabilitation training of experimental arm.
Other outcomes:
Locations:
Study officials:
affiliation: Casa di Cura Privata del Policlinico SpA
name: Peppino Tropea, PhD
role: PRINCIPAL_INVESTIGATOR
References: