Clinical trial NCT05598892: Hand Rehabilitation Based on a RobHand Exoskeleton in Stroke Patients: a Case Series Study
Official title: Hand Rehabilitation Based on a RobHand Exoskeleton in Stroke Patients: a Case Series Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Hand Rehabilitation
Exoskeleton
Lead sponsor: Corporación de Rehabilitación Club de Leones Cruz del Sur
Sponsor class: OTHER
Collaborators: name: University of Valladolid
name: Universidad de Magallanes
First posted: 2022-10-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The following study seeks to provide information regarding to the RobHand exoskeleton for hand neuromotor maintenance and/or rehabilitation, developed by the University of Valladolid, Spain.

Detailed description: The following study seeks to provide information regarding to the RobHand exoskeleton for hand neuromotor maintenance and/or rehabilitation, developed by the University of Valladolid, Spain. The study was carried out by the Neurotchnology Group of the Research and Development Area of the Corporación de Rehabilitación Club de Leones Cruz del Sur, Chile. Clinical test were implemented on four subjects with Stroke sequelae who participated in two evaluations of manual function and 16 training sessions with the robotic exoskeleton, in order to know the clinical effects on manual function, safety and satisfaction of users who utilize the exoskeleton RobHand.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Active patient at the Rehabilitation Center Club de Leones Cruz del Sur
* At least 1 Hemorrhagic or ischemic stroke
* Adequate level of consciousness
* Paresis of the upper extremities
* Patient who signed the inform consent

Exclusion Criteria:

* Comorbidities in the central nervous system
* Pain in the upper extremity (hand, forearm, arm)
* Patient who does not sign the informed consent

Primary outcomes:
measure: Dynamometry - Grip Baseline
timeFrame: Baseline
measure: Dynamometry - Grip Post Intervention
timeFrame: 8 weeks
Secondary outcomes:
measure: Nine Hole Peg Test (9-HPT) Baseline
timeFrame: Baseline
measure: Nine Hole Peg Test (9-HPT) Post Intervention
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Punta Arenas
country: Chile
facility: Corporación de Rehabilitación Club de Leones Cruz del Sur
state: XII Región
Study officials:
affiliation: Rehabilitation Center Club de Leones Cruz del Sur
name: Asterio H Andrade, PhD
role: STUDY_CHAIR
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