Validation of the Efficacy and Usability of the BELK Orthosis Knee Module in a Neurological Setting (BELK@CCP)

NCT04173975 | Withdrawn

• 1 other identifier: BELK@CCP
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Instability; Neuromuscular Diseases; Central Nervous System Diseases; Stroke

Outcome Measures

Primary Outcomes (2)

• Change in walking velocity

  Walking velocity \[m/s\] will be calculated during walk test (10MWT). Markers positioned on the body will be tracked through a motion capture software and analyzed.

  Before and Immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)

• Change in Gait Profile Score

  Gait Profile Score (GPS) is a useful index to analyze the gait performances. It is calculated starting from fifteen Gait Variable Score (GVS) which give a deeper view on the variables related to the locomotion trials.

  Before and Immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)

Secondary Outcomes (10)

• Change in 6-minute walking test (6MWT)

  Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)

• Change in joint force

  Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)

• Change in Surface electromyography (sEMG)

  Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)

• Change in energy cost of walking

  Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)

• Change in Stair Climb Test (SCT)

  Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)

Study Arms (2)

With knee exoskeleton

EXPERIMENTAL

The rehabilitation training will be focused on lower limb with specific activities for knee instability, and 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). Each session will be 45 minutes long. Three time per week, for three weeks. The patients allocated in this arm will perform the training wearing the BELK device.

Device: With knee exoskeleton

Without exoskeleton

NO INTERVENTION

The rehabilitation training will be focused on lower limb with specific activities for knee instability, and 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). Each session will be 45 minutes long. Three time per week, for three weeks. The patients allocated in this arm will perform the training without any exoskeleton.

Interventions

With knee exoskeleton DEVICE

BELK is a wearable system that assists when and where the patient needs it intelligently through proper control of the system and optimized gait assistance techniques. Assisted-as-needed control allows to create a force field along a desired trajectory, proportionally applying torque only when patient deviates from the pre-programmed correct pattern. This force field control, by assisting only the segments that the patient need, produces a natural gait pattern, improving the rehabilitation process.

With knee exoskeleton

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Casa di Cura Privata del Policlinico SpA: lead

MeSH Terms

Conditions

Neuromuscular Diseases; Central Nervous System Diseases; Stroke

Condition Hierarchy (Ancestors)

Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Peppino Tropea, PhD

  Casa di Cura Privata del Policlinico SpA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 22, 2019
• Study Start: January 1, 2021
• Primary Completion: March 31, 2021
• Study Completion: August 31, 2021
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share