Clinical Research Directory

ESTIM-UL: FES for Upper Limb Recovery After Stroke

Stroke is a leading cause of long-term disability, frequently resulting in impaired upper limb motor function and spasticity. Although Botulinum Toxin Type A (BoNT-A) is effective in reducing focal spasticity, functional recovery of the upper limb often remains limited without intensive, task-specific rehabilitation. Functional Electrical Stimulation (FES), when synchronized with voluntary movement during Task-Oriented Training, may enhance motor recovery by facilitating muscle activation and neuroplasticity. This randomized controlled trial aims to evaluate whether FES combined with Task-Oriented Training is superior to conventional Task-Oriented Training alone in improving upper limb function in post-stroke patients treated with BoNT-A.

Efficacy of Focused Shock Wave Therapy Before and After Botulinum Toxin Injection in Patients With Post-Stroke Spastic Equinus/Equinovarus Foot: A Randomized Clinical Trial

Spastic equinovarus foot is the most common lower limb motor impairment after stroke and has a significant impact on gait, mobility, and quality of life. Botulinum toxin type A (BoNT-A) is considered the first-line treatment for focal post-stroke spasticity. Extracorporeal shock wave therapy (ESWT) has shown promising results as an adjunctive treatment; however, the optimal timing for its administration in combination with BoNT-A remains unknown. This prospective, randomized, evaluator-blinded clinical trial aims to determine whether focal ESWT administered before or after BoNT-A injection is more effective than BoNT-A alone in patients with chronic post-stroke spastic equinovarus foot. Sixty-nine participants will be randomly allocated to one of three treatment groups: (1) BoNT-A alone; (2) one session of focal ESWT immediately before BoNT-A injection; or (3) one session of focal ESWT two weeks after BoNT-A injection. The primary outcome is spasticity measured with the Modified Ashworth Scale (MAS). Secondary outcomes include the Modified Tardieu Scale, passive ankle range of motion, muscle strength (MRC), 10-Meter Walk Test (10MWT), Functional Ambulation Classification (FAC), pain (VAS), Patient-Specific Assessment Scale (PSAS), muscle echogenicity using the Heckmatt scale, and muscle stiffness assessed by real-time elastography. Assessments will be performed at baseline and during follow-up through week 54.

A Pilot Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants With Post-Stroke Spasticity (The STIPS Study)

The goal of this clinical trial is to learn if the drug BMS-986368 works to treat post stroke spasticity in adults who have had a stroke. BMS-986368 is a designed to increase natural compounds in the body that may help calm nerves that cause muscles to be tight or spasm. The study will also learn about the safety of drug BMS-986368

Effect of Extracorporeal Shock Wave Therapy on Spasticity and Mobility in Stroke Patients

This study aims to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) in individuals with lower limb spasticity following stroke. Spasticity is a common complication after stroke and can negatively affect walking ability, mobility, and quality of life. Participants will be randomly assigned to one of two groups. Both groups will receive a standard physiotherapy and rehabilitation program. In addition, the intervention group will receive ESWT applied to the lower limb muscles, while the control group will receive a sham (placebo) ESWT application. The treatment program will be conducted three times per week for four weeks. Clinical assessments will be performed at baseline, after treatment, and during follow-up. The main outcomes of the study include muscle tone (spasticity), walking performance, motor function, and quality of life. The results of this study may help improve rehabilitation strategies and provide evidence for the use of ESWT in stroke patients.