Robotic Hand Rehabilitation in Stroke Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The performance of activities of daily living (ADL) depends to a large extent on the functionality of the upper limb and hand. Stroke is the leading cause of disability worldwide, with a significant individual, family and economic impact. After a stroke event, however, a large percentage of affected patients have a deficit of the hand and, six months after the acute event, 65% of patients with a deficit of the hand are unable to use and integrate the affected hand in activities of daily living, significantly reducing its quality. The impairment of strength, grip and general hand function makes it difficult to perform ADLs and affects the independence of functional activities, making the recovery of hand function an extremely challenging field in stroke rehabilitation.
Detailed Description
Rehabilitation of the hand in stroke patients has changed substantially over the last decades, with an increasing interest in the use of robotic devices for the treatment of the upper limb. Indeed, the use of such systems makes it possible to increase the amount and intensity of therapy, to standardise treatment, to provide complex but controlled multisensory stimulation, and to support the patient while performing various tasks, preventing inappropriate movements. Moreover, through robotic systems it is possible to acquire kinematic and kinetic data that are processed to obtain quantitative indices in order to objectively evaluate the patient's motor performance before and after the rehabilitation treatment. Amadeo® (Tyromotion, Austria) is an end-effector type robotic device, specifically designed for hand treatment, effective in reducing hand disability in stroke patients. The aim of the study is to evaluate the effects of robotic rehabilitation with an Amadeo® hand end-effector robot (Tyromotion, Austria): (i) in terms of improved hand function (assessed by clinical and instrumental scales); (ii) on fatigue and quality of life. 24 patients will be recruited at the UOS Post-Acute Rehabilitation, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome. Patients will be divided into two groups by randomization: one group (experimental group, GA) will perform specific rehabilitation for balance disorders using the end-effector robot Amadeo® (Tyromotion, Austria) 3 times a week, for 4 weeks (12 total sessions), for 45 minutes of treatment, in addition to the conventional treatment, and one group will perform only the conventional treatment (conventional group, GC), as a daily routine, as described below.
Investigators
GIOVANNINI SILVIA
Principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Eligibility Criteria
Inclusion Criteria
- •Patients with ischaemic or haemorrhagic stroke documented by neuroimaging techniques (magnetic resonance imaging or computed tomography)
- •Latency since acute event between 1 and 6 months;
- •Cognitive ability to execute simple orders and understand the physiotherapist's instructions, assessed by Token Test (score ≥ 26.5);
- •Ability to understand and sign informed consent.
Exclusion Criteria
- •Presence of a pincer grip "possible against resistance but weaker than the contralateral" as assessed by the Upper Limb Motricity Index ≥ 26;
- •Behavioural, cognitive disorders and/or reduced compliance that could interfere with rehabilitation treatment;
- •Presence of ankylosis as assessed by the modified Ashworth Scale ≥ 4;
- •Inability to discriminate distinctly between images displayed on a monitor placed at eye level of each subject at a distance of approximately 50 cm, even with corrective glasses;
- •Inability to provide informed consent.
Outcomes
Primary Outcomes
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Time Frame: Change from Baseline FMA-UE at 4 weeks
The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index. Upper Extremity section is designed to assess motor functioning, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. For each item, a score can be assigned on direct observation of performance. The scale items are scored according to the ability to complete the item using a 3-point ordinal scale where 0=not able to perform, 1=performs partially and 2=performs completely. The motor function macro-area has a maximum total score of 66; the sensitivity macro-area has a maximum total score of 60.
Secondary Outcomes
- Motricity Index - Upper Limb (MI-UL)(Change from Baseline MI-UL at 4 weeks)
- EuroQol- 5 Dimension (EQ-5D)(Change from Baseline EQ-5D at 4 weeks)
- The Medical Research Council (MRC) Scale(Change from Baseline MRC at 4 weeks)
- Modified Fatigue Impact Scale (MFIS)(Change from Baseline MFIS at 4 weeks)
- Fatigue Scale for Motor and Cognitive Function (FSMC)(Change from Baseline FSMC at 4 weeks)
- Stroke Upper Limb Capacity Scale (SULCS)(Change from Baseline SULCS at 4 weeks)
- Box&Block test (BBT)(Change from Baseline BBT at 4 weeks)
- HandGrip Test (HGT)(Change from Baseline HGT at 4 weeks)
- 9-Hole Peg test (9HPT)(Change from Baseline 9HPT at 4 weeks)
- Modified Ashworth Scale (MAS)(Change from Baseline MAS at 4 weeks)
- modified Barthel Index (mBI)(Change from Baseline mBI at 4 weeks)