Clinical trial NCT05983822: Robotic Hand Rehabilitation
Official title: Robotic Hand Rehabilitation in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Spasticity as Sequela of Stroke
Upper Limb
Keywords: Stroke
Robotic rehabilitation
Upper limb
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
timeFrame: Change from Baseline FMA-UE at 4 weeks
Secondary outcomes:
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Change from Baseline MFIS at 4 weeks
measure: Fatigue Scale for Motor and Cognitive Function (FSMC)
timeFrame: Change from Baseline FSMC at 4 weeks
measure: The Medical Research Council (MRC) Scale
timeFrame: Change from Baseline MRC at 4 weeks
measure: Motricity Index - Upper Limb (MI-UL)
timeFrame: Change from Baseline MI-UL at 4 weeks
measure: Stroke Upper Limb Capacity Scale (SULCS)
timeFrame: Change from Baseline SULCS at 4 weeks
measure: 9-Hole Peg test (9HPT)
timeFrame: Change from Baseline 9HPT at 4 weeks
measure: Box&Block test (BBT)
timeFrame: Change from Baseline BBT at 4 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: Change from Baseline MAS at 4 weeks
measure: HandGrip Test (HGT)
timeFrame: Change from Baseline HGT at 4 weeks
measure: modified Barthel Index (mBI)
timeFrame: Change from Baseline mBI at 4 weeks
measure: EuroQol- 5 Dimension (EQ-5D)
timeFrame: Change from Baseline EQ-5D at 4 weeks
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Silvia Giovannini, MD, phD
role: PRINCIPAL_INVESTIGATOR
References: