Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation

Fondazione Salvatore Maugeri30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Interventions

General RehabilitationOTHER

All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.

Specific hand rehabilitation by Gloreha deviceDEVICE

Each training session consisted of six parts: 1. A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2. 7 min of a number sequence (counting from one to five); 3. A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4. A sequence of wave-like finger movements (7 min) 5. A sequence of fist opening/closing (7 min) 6. A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).

Specific hand rehabilitation performed by physiotherapistOTHER

The activities were: 1. Flexion-extension of the fingers (10 min); 2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min); 3. Adduction and abduction of the fingers (10 min); 4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).

Outcomes

Primary Outcomes

Number of Patients Who Completed the Hand Rehabilitation Program

Time frame: 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.

Side Effects Using Gloreha Device

The feasibility of the device was assessed in terms of side effects (the physiotherapist was required to report any adverse events occurring during the study in regard to the use of Gloreha);

Time frame: 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.

Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Motricity Index at End of Inpatient Rehabilitation

Motricity Index, a measure of the motor function of the paretic upper limb. Motricity Index used to measure the ability to activate a muscle group to move a body segment through a range of motion and resist external force. The upper extremity motricity index includes: 1. pinch grasp, 2. elbow flexion, and 3. shoulder abduction. The total upper extremity score involved adding one to the sum of the three actions. The score of each action ranges from 0 (no ability) to 33 (maximal ability) with a maximum possible score=100.