Home-based rehabilitation for upper limb recovery after stroke

Dynamic Perturbation Training for Home-Based Upper Limb Rehabilitation in Chronic Stroke: A Randomized Controlled Trial

This study is testing if a special home rehabilitation program using a resistance device can help people recover better use of their arms after a chronic stroke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital of Ferrara (Academic / other)
• Locations: 1 site (Ferrara, Emilia-Romagna)
• Trial ID: NCT06992700 on ClinicalTrials.gov

What this trial studies

This study focuses on improving upper limb function in patients who have experienced a chronic stroke through a home-based rehabilitation program. Participants will be randomly assigned to either an experimental group, which uses a specialized orthosis with dynamic resistance, or a control group that uses the orthosis without resistance. The program consists of two daily sessions over ten days, with remote supervision to ensure adherence and safety. The study aims to assess the effectiveness of dynamic perturbation training in enhancing motor recovery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced a first stroke at least six months prior and have upper limb motor deficits.

Not a fit: Patients with severe cognitive dysfunction, significant medical conditions, or those unable to perform basic movements with their fingers may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve upper limb function and quality of life for stroke survivors.

How similar studies have performed: Other studies have shown promise in using home-based rehabilitation techniques for stroke recovery, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Males and females aged 18 years or older;
* Diagnosis of first cerebral stroke (ischaemic or haemorrhagic) in the chronic phase (i.e. at least 6 months after the onset of the acute event) verified by brain imaging (brain computed tomography and/or magnetic resonance imaging);
* Motor deficit in the upper limb - and in particular in the hand - caused by stroke, not attributable to other conditions or diseases and not such as to preclude the ability to perform movements with the fingers and to perform movements to grasp objects;
* Ability to express informed consent correctly.
* Availability of a webcam and Internet connection at home for remote supervision of activities by the staff involved in the study.

Exclusion Criteria:

* Medical conditions that may interfere with the ability to safely complete the study protocol;
* Cognitive dysfunction that precludes informed consent;
* Severe neuropsychological disorders;
* Severe visual problems;
* Upper limb pain assessed with Visual Analogue Scale (VAS) \> 7;
* Severe internal diseases (e.g. cardiopulmonary, renal, hepatic);
* Diseases with inflammatory skin lesions, wounds, sensory and circulatory disorders below the elbow and on the hand in the area of application;
* Contraindications to transcranial magnetic stimulation (TMS) procedures, assessed as indicated by international reference, such as: presence of intracranial metal implants, positive history of epilepsy, frequent migraines, implantable devices (ventricular-peritoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants). It should be noted that the presence of this type of exclusion criterion will preclude the performance of TMS assessments, but not the remaining procedures of the study;
* Pregnancy.

Where this trial is running

Ferrara, Emilia-Romagna

• Ferrara University Hospital — Ferrara, Emilia-Romagna, Italy (Recruiting)

Study contacts

• Study coordinator: Sofia Straudi, MD PhD

Conditions Stroke; Neurorehabilitation