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NCT05729633
Robot Mediated Therapy-Feasibility Study and Preliminary Effects
Conditions: Stroke
Sex: All
Ages: 21 Years – 99 Years
Phase: NA
Enrollment: 4
Sponsor: Changi General Hospital
Summary
The goal of this clinical trial is to investigate the feasibility of the application of robot mediated impairment-training (RMIT) and robot mediated task-specific training (RMTT) in acute stroke patients with upper limb impairments.The main question[s] it aims to answer are:Is it feasible and safe to conduct RMIT and RMTT in acute stroke patients with upper limb impairments?What are the preliminary effects on the physical function and quality of life in these patients?Participants will undergo 20 hours of robot mediated upper limb therapy.Researchers will compare RMIT with RMIT+RMTT to see if there are any differences in the effects on physical function and quality of life.
Eligibility Criteria
Inclusion Criteria:Diagnosis of stroke as evidenced by CT/MRI findingsFirst-ever stroke (ischaemic or haemorrhagic)Upper limb weakness and an FMA-UE score of 16-53 (severe to moderate: 16-34.
moderate to mild: 35-53)12,13Cognitively intact to follow instructionsMedically stable to participateConsent givenAge 21 and above (investigating adult stroke patients)Exclusion Criteria:Fractures or other musculoskeletal issues that render the use of the robotic device unsuitableInvolvement in another concurrent upper limb studyWounds that do not allow donning of the deviceSevere spasticityCognitive impairment (MMSE ≤20)Inability to follow instructionsSevere osteoporosisInfectious diseases
Source: ClinicalTrials.gov (NCT05729633). StuddyBuddy aggregates publicly available trial information.