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NCT05983822Completed

Robotic Hand Rehabilitation

Robotic Hand Rehabilitation in Stroke Patients

Source: ClinicalTrials.gov · Last updated 13 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
24 (actual)
First submitted
2 Aug 2023
Start date
2 Oct 2023
Primary completion date
30 Apr 2024
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Diseases
Stroke
NCT number
NCT05983822

What you commit to

  • Study type: Interventional
  • Participants enrolled: 24
  • From 2 Oct 2023 to the primary completion date, 30 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Behavioural, cognitive disorders and/or reduced compliance that could interfere with rehabilitation treatment;

Other

  • Presence of a pincer grip "possible against resistance but weaker than the contralateral" as assessed by the Upper Limb Motricity Index ≥ 26;
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione Policlinico Universitario A. Gemelli IRCCS
Coordinator of this site? Confirm its status
RomaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.