Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation

Fondazione Salvatore Maugeri

Status: Completed

Conditions: Stroke; Upper Extremity Hemiplegia; Disorder of Hand

Treatments: Other: General Rehabilitation; Device: Specific hand rehabilitation by Gloreha device; Other: Specific hand rehabilitation performed by physiotherapist

Study type: Interventional

Funder types: Other

Identifiers

NCT02628418

1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Gloreha Group

Experimental group

Description:

The patients in the "Gloreha Group" underwent to following interventions: 1. General Rehabilitation 2. Specific hand rehabilitation by Gloreha device

Treatment:

Device: Specific hand rehabilitation by Gloreha device

Other: General Rehabilitation

Control Group

Other group

Description:

The patients in the Control Group underwent to following interventions: 1. General Rehabilitation 2. Specific hand rehabilitation performed by physiotherapist

Treatment:

Other: General Rehabilitation

Other: Specific hand rehabilitation performed by physiotherapist