Robotic Hand Rehabilitation

NCT ID: NCT05983822

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2024-10-28

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.

Conditions

Stroke; Spasticity as Sequela of Stroke; Upper Limb

Keywords

Stroke; Robotic rehabilitation; Upper limb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group (GA)

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.

Group Type: EXPERIMENTAL

Technological Group

Intervention Type: DEVICE

Specific rehabilitation for the recovery of hand function using the end-effector robot

Conventional Group (GC)

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

Group Type: ACTIVE_COMPARATOR

Technological Group

Intervention Type: DEVICE

Specific rehabilitation for the recovery of hand function using the end-effector robot

Conventional Treatment

Intervention Type: OTHER

Conventional rehabilitation

Interventions

Technological Group

Specific rehabilitation for the recovery of hand function using the end-effector robot

Intervention Type: DEVICE

Conventional Treatment

Conventional rehabilitation

Intervention Type: OTHER

Other Intervention Names

Amadeo® (Tyromotion, Austria)

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

GIOVANNINI SILVIA

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvia Giovannini, MD, phD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy

Countries

Italy

Other Identifiers

0000052/23

Identifier Type: -

Identifier Source: org_study_id