Medicines added to robot-assisted arm therapy after stroke to aid movement recovery

Trial details

Who runs it

Spaulding Rehabilitation Hospital

Trial code

NCT07588932

Record updated

14 July 2026

Original description

The goal of this trial is to study if the concomitant administration of Telmisartan, Cilostazol IR (immediate release), and Metformin ER (extended release) can help stroke survivors make greater gains in movement and recovery during robot-assisted arm and hand rehabilitation.Read full original descriptionShow less

Relying on Pharmacotherapy to Improve Motor Gains of Robot-Assisted Upper-Extremity Rehabilitation in Chronic Stroke Survivors

The goal of this trial is to study if the concomitant administration of Telmisartan, Cilostazol IR (immediate release), and Metformin ER (extended release) can help stroke survivors make greater gains in movement and recovery during robot-assisted arm and hand rehabilitation.

Inclusion: Adults between 21 and 80 years of age; History of ischemic stroke; Stroke occurred at least six months prior to recruitment; Moderate to severe UE impairment (FMA-UE score between 15 and 40); MMSE score >=20 and being able to safely follow three-step commands.

Exclusion: Taking dual antiplatelet therapy (e.g., Aspirin+Plavix) and/or other anticoagulation medications (e.g., Eliquis, coumadin) that cannot safely be modified or discontinued (as determined by the participant's primary care physician or by the medical monitor); Taking any medication that the study physician determines to have a significant drug-drug interaction with Telmisartan, Cilostazol, and/or Metformin; Taking medications with equivalent clinical effect (e.g., BP control) to Telmisartan, Cilostazol, and/or Metformin and that cannot be replaced by Telmisartan, Cilostazol, and/or Metformin (as determined by the participant's primary care physician or by the medical monitor); Previous diagnosis of neurological diseases other than stroke that would have a negative impact on the response to the rehabilitation intervention (e.g., severe dystonia affecting the UE) or would prevent safe participation in RA UE training (e.g., uncontrolled seizures); Undergoing Botox treatment for pain/spasticity related to the affected upper extremity, in the 4 months prior to enrollment or during the study period; Participation in another therapy focused on the recovery of the impaired UE; Contraindications to the pharmacotherapy (e.g., heart failure, known medication reaction or interactions with ongoing medication regimen); Cerebellar and/or hemorrhagic stroke; Individuals who present with the following on the impaired UE: open wounds, fragile skin, and under contact precautions due to an active infection; Subjects with cardiac pacemakers, electronic pumps, or any other implanted medical devices that are not US-certified (and hence might be affected by the electromagnetic interference generated by the robot); Any condition that would prevent proper/safe use of the robotic system, such as proprioceptive deficits that impair the ability to process haptic or visual feedback, or unstable shoulder joint as assessed by physical examination; Clinically significant somnolence and/or depression that would hinder active participation in motor training sessions; Taking Telmisartan, Cilostazol, and/or Metformin in a dose that is different from the one used in the study and that cannot be adjusted to match the study dose (as determined by the participant's primary care physician or by the medical monitor); A body mass index (BMI) below 25 (as the proposed pharmacotherapy could cause hypoglycemia in participants with normal-low BMI); Severe musculoskeletal pathology or recent fractures affecting the impaired UE that would prevent safe use of the rehabilitation robotic system; Moderate to severe disability due to migraines as determined using the Migraine Disability Assessment test (score > 10); Severe spasticity (Modified Ashworth Scale for spasticity ≥ 3 for UE muscles) that would prevent safe use of the robotic system utilized during training; Severe aphasia limiting the ability to express needs or discomfort verbally or non-verbally; Visual impairments that would prevent proper use of interactive on-screen games during RA UE training; Severe hemispatial neglect as assessed using the Line Bisection Test (missed lines >2); Severely impaired trunk control that would prevent sitting safely on a chair without arms; Current pregnancy.

ClinicalTrials.gov NCT07588932