Clinical trial NCT02628418: Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation
Official title: Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation in Hemiplegic Stroke Patients: a Randomized Pilot Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Upper Extremity Hemiplegia
Disorder of Hand
Keywords: Rehabilitation
Robotics
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hand recovery following cerebral stroke is complex and requires intensive training. The investigators aimed to evaluate the feasibility and efficacy of robot-assisted hand rehabilitation compared to physiotherapist-guided treatment in recovering dexterity and hand strength in hospitalized sub-acute hemiplegic patients. Design. 30 patients affected by stroke from cerebral ischemia or hemorrhage (Ashworth spasticity index \<3) were randomized. Patients in the Treatment group received intensive hand training with Gloreha, a hand rehabilitation glove that provides computer-controlled, repetitive, passive mobilization of the fingers, with multisensory feedback. Patients in the Control group received conventional intensive hand rehabilitation under physiotherapist guidance. Hand motor function (Motricity Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip and Pinch test) were measured at baseline and after rehabilitation, and the differences between final and basal results were compared between groups.

Detailed description: Upper limb recovery, particularly that of the hand, is complex in patients with cerebral stroke and requires an intensive approach.

Regarding upper limb rehabilitation, several research groups have developed robotic devices to provide passive and/or active movements. Their use appears to reduce the motor deficit of the arm and affected hand and to improve hand function both at the wrist and fingers. Hence, the evidence supporting specific robot-assisted rehabilitation of the hand is very promising even if further study is required.In particular, evidence is limited about the benefit of passive exercises and mobilization of the hemiplegic upper limb following stroke, and further research is called for.

In this study the investigators used Gloreha, a new hand rehabilitation glove that provides computer-controlled, repetitive and passive mobilization of the fingers, with multi-sensory feedback. The purpose of the study was to evaluate in the rehabilitation of patients with ischemic or hemorrhagic stroke in the sub-acute phase: 1) the feasibility of this new neuromotor rehabilitation device 2) its efficacy in improving arm function abilities, and 3) the costs involved.

Post-stroke patients admitted for inpatient rehabilitation between May 2013 and January 2014 were screened for enrollment. Eligible patients were randomly assigned, following a simple randomization procedure (computerized random numbers) conducted independently of the study investigators, to Treatment group or Control group, on a 1:1 ratio.

Eligibility criteria: Inclusion Criteria:

* Patients affected by stroke from cerebral ischemia or hemorrhage that had occurred ≤ 30 days before, with Ashworth spasticity index \< 3.

Exclusion Criteria:

* orthopedic limitation (amputations, irreducible articular limitations, advanced osteoarthritis, active rheumatoid arthritis);
* peripheral nerve injury;
* uncontrolled inflammation;
* severe cognitive and behavioral disorders;
* neurodegenerative and neuromuscular diseases;
* Ashworth spasticity index ≥ 3.

Primary outcomes:
measure: Number of Patients Who Completed the Hand Rehabilitation Program
timeFrame: Through study completion. The specific hand interventionn consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.
measure: Side Effects Using Gloreha Device
timeFrame: Through study completion. The specific hand intervention consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.
measure: Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Motricity Index at End of Inpatient Rehabilitation
timeFrame: Baseline and end of the study after 30 sessions, an average of 6 weeks
measure: Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Nine Hole Peg Test at End of Inpatient Rehabilitation.
timeFrame: Baseline and end of the study after 30 sessions, an average of 6 weeks
Secondary outcomes:
measure: The Feasibility of This New Neuromotor Rehabilitation Device (Gloreha)
timeFrame: Baseline and end of the study after 30 sessions, an average of 6 weeks
measure: Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Grip Test at End of Inpatient Rehabilitation.
timeFrame: Baseline and end of the study after 30 sessions, an average of 6 weeks
measure: Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Pinch Test at End of Inpatient Rehabilitation.
timeFrame: Baseline and end of the study after 30 sessions, an average of 6 weeks
measure: Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Quick-DASH Questionnaire at End of Inpatient Rehabilitation.
timeFrame: Baseline and end of the study after 30 sessions, an average of 6 weeks
measure: The Costs Involved in Using Gloreha in the Rehabilitation
timeFrame: Through study completion, from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.
Other outcomes:
Locations:
Study officials:
References:
citation: Vanoglio F, Bernocchi P, Mule C, Garofali F, Mora C, Taveggia G, Scalvini S, Luisa A. Feasibility and efficacy of a robotic device for hand rehabilitation in hemiplegic stroke patients: a randomized pilot controlled study. Clin Rehabil. 2017 Mar;31(3):351-360. doi: 10.1177/0269215516642606. Epub 2016 Jul 10.