Evaluation of Exoskeleton for Upper Limb Rehabilitation in Neurological Patients
- Conditions
- StrokeNeurologic Disorder
- Interventions
- Device: AGREE exoskeletonOther: Conventional therapyDevice: FEXO exoskeleton
- Registration Number
- NCT05280431
- Lead Sponsor
- Casa di Cura Privata del Policlinico SpA
- Brief Summary
Acquired cerebrovascular trauma is the third most common cause of disability worldwide, resulting in long-term disability, limitation of activities of daily living, and reduced social participation. It is estimated that, within three months of the acute event, a high percentage of patients do not recover full function. 93% of these disabilities concern the upper limb.
To induce optimal functional reorganization after the acute cerebrovascular events or neurodegenerative diseases affecting the central nervous system, robotic assistance allows intensive exercises with specific therapeutic purposes. Indeed, they enable an intensive, repetitive, and customizable therapeutic program that is in line with the principles underlying motor learning.
Clinical investigation is needed to assess the efficacy of the proposed new technologies (AGREE and FEXO exoskeleton) and to guide subsequent developmental steps. Therefore, an exploratory clinical study is proposed to evaluate usability, tolerability, and safety, as well as to assess the effectiveness of the new technologies.
The primary objective of this study is to examine the safety and tolerability of the new active exoskeletons for upper extremity rehabilitation and validate them in a controlled environment. Furthermore, efficacy will be examined as the secondary outcome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- age between 18 and 85 years;
- motor deficit of the upper limb induced by neurological diseases (e.g., stroke, multiple sclerosis);
- time since the acute event of at least one month;
- Trunk Control Test score ≥ 48.
- global aphasia;
- presence of cognitive impairment;
- severe unilateral spatial neglect;
- Box and Block test < 1;
- Ashworth scale score ≥ 4;
- total or severe impairment of visual acuity;
- instability of clinical parameters or presence of severe comorbidities;
- inadequate anthropometric measurements;
- presence of any serious condition that may affect participation in the study (e.g., oncological, hepatic/renal, immune, metabolic/endocrine, psychiatric, respiratory or infectious disorders);
- inability to comply with the protocol or to give informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group (AGREE) AGREE exoskeleton 15 sessions, 3 sessions per week. Each session consists of 45 minutes of training with the AGREE exoskeleton. The training session is customized to the patient's needs and can be adapted to his/her improvement during the intervention. Control Group (Conventional therapy) Conventional therapy 15 sessions, 3 sessions per week. Each session consists of 45 minutes and consists of different training modalities typically used in the rehabilitation of the arm after stroke. Experimental Group (FEXO) FEXO exoskeleton 15 sessions, 3 sessions per week. Each session consists of 45 minutes of training with the FEXO exoskeleton. The training session is customized to the patient's needs and can be adapted to his/her improvement during the intervention.
- Primary Outcome Measures
Name Time Method System Usability Scale (SUS) up to 5 weeks SUS is used to measure how easy or difficult the proposed system is to use
- Secondary Outcome Measures
Name Time Method Smoothness described by the Teulings's index (TI) up to 5 weeks TI s the rate of change of the acceleration in a movement; a lower value of TI indicates a smoother movement
Visual Analogue Scale (VAS) up to 5 weeks VAS is a psychometric response scales used to measure subjective pain
Fugl-Meyer Assessment Scale (FMA-UE) up to 5 weeks FMA-UE assesses sensorimotor status including items assessing upper extremity motion, balance, sensation and range of movement
Action Research Arm Test (ARAT) up to 5 weeks ARAT is used to assess upper extremity performance (coordination, dexterity and functioning)
Technology Assessment Methods (TAM) up to 5 weeks TAM is an information systems theory that models how users come to accept and use a technology
Modified Ashworth Scale (MAS) up to 5 weeks MAS is used to muscle quantified spasticity
Motricity Index (MI) up to 5 weeks MI is used to grade motor activity in muscles of the upper limb
Event-Related Desynchronization and Synchronization (ERD/ERS) of the μ and β rhythms up to 5 weeks Motor processing can result in changes of the ongoing EEG in form of an event-related desynchronization (ERD) or event-related synchronization (ERS). Spatial mapping of ERD/ERS can be used to study the dynamics of cortical activation patterns
Virtual Reality Questionnaire (VR) up to 5 weeks VR is used to measure how easy or difficult the virtual reality interface is to use
Box and Block Test (BBT) up to 5 weeks BBT measures unilateral gross manual dexterity. The BBT administration consists of asking the subject to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds
Nine Hole Peg Test (9HPT) up to 5 weeks 9HPT is used to measure finger dexterity in patients. The 9HPT administration consist of asking the subject to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible
Number of Peaks (#Peaks) of the speed profile up to 5 weeks If a point-to-point reaching movement has a low number of peaks, it means that few acceleration and deceleration periods are present
The absolute hand path error (e) up to 5 weeks e is the area between the actual movement path and the straight line; this was considered an index of learning and a reduction of e indicates a better adaptation to the required task.
Trial Locations
- Locations (1)
Casa di Cura del Policlinico
🇮🇹Milan, MI, Italy