Status:
COMPLETED
Robotic Hand Rehabilitation
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Stroke
Spasticity as Sequela of Stroke
Eligibility:
All Genders
55+ years
Phase:
NA
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 i...
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, th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05983822
Start Date
October 2 2023
End Date
October 28 2024
Last Update
December 13 2024
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, Italy, 00168