Robotic Hand Rehabilitation (RoHa-S)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Stroke; Spasticity as Sequela of Stroke; Upper Limb

Treatments: Other: Conventional Treatment; Device: Technological Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05983822

0000052/23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Experimental Group (GA)

Experimental group

Description:

The experimental group (GA) will perform specific rehabilitation for the recovery of hand function 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 conventional treatment. In particular, the technological rehabilitation performed using the robot will mostly aim at improving finger mobility and strength, and flexion-extension exercises will be proposed in passive, active assisted and active mode, exercises for improving strength and muscle tone.

Treatment:

Device: Technological Group

Conventional Group (GC)

Active Comparator group

Description:

GC patients will undergo conventional rehabilitation treatment only, using the main rehabilitation methods (e.g. neurocognitive theory, progressive neuromuscular facilitation, etc.).

Treatment:

Device: Technological Group

Other: Conventional Treatment