Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation

Not Applicable

Completed

• Conditions: Upper Extremity Hemiplegia; Disorder of Hand; Stroke
• Interventions: Other: General Rehabilitation; Device: Specific hand rehabilitation by Gloreha device; Other: Specific hand rehabilitation performed by physiotherapist

• Registration Number: NCT02628418
• Lead Sponsor: Fondazione Salvatore Maugeri

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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-03
• Study Completion: 2014-06
• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-11
• Results First Submitted: 2016-02-05
• Results First Submitted QC: 2016-06-21
• Status Verified: 2016-08
• Results First Posted: 2016-08-03
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Nine Hole Peg Test at End of Inpatient Rehabilitation.	Baseline and end of the study after 30 sessions, an average of 6 weeks	Nine Hole Peg Test (NHPT), a measure of coordination and mono-manual dexterity. It consists in collecting 9 pegs and inserting them into holes in a wooden base within a 50-sec time limit. The score is the average number of pegs inserted/tests performed.
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Motricity Index at End of Inpatient Rehabilitation	Baseline and end of the study after 30 sessions, an average of 6 weeks	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.
Number of Patients Who Completed the Hand Rehabilitation Program	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	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.	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);

Secondary Outcome Measures

Name	Time	Method
The Feasibility of This New Neuromotor Rehabilitation Device (Gloreha)	Baseline and end of the study after 30 sessions, an average of 6 weeks	The feasibility of the device was assessed in terms of the level of operator difficulty for the physiotherapist in managing the device, assessed by visual analogue scale (VAS) (0 extremely simple - 10 extremely difficult). This outcome was measured only in the Gloreha Group in which patients were treated with device.
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Pinch Test at End of Inpatient Rehabilitation.	Baseline and end of the study after 30 sessions, an average of 6 weeks	The Pinch test is a measure of hand strength. Each patient, at baseline and at the end of the study, repeated the test 3 times and the mean value was normalized for body mass index (BMI).
The Costs Involved in Using Gloreha in the Rehabilitation	Through study completion, from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.	Costs were calculated in terms of the time required by healthcare personnel, using the average cost per hour of a physiotherapist per total number of rehabilitation treatments per patient. The equivalent cost of the device for the period of patient treatment was calculated incorporating depreciation, considering the estimated residual value of the device with depreciation rate of 20%.. Indirect costs were not considered because these were common to both groups.
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Grip Test at End of Inpatient Rehabilitation.	Baseline and end of the study after 30 sessions, an average of 6 weeks	The Grip test is a measure of hand strength. Each patient, at baseline and at the end of the study, repeated the test 3 times and the mean value was normalized for body mass index (BMI).
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Quick-DASH Questionnaire at End of Inpatient Rehabilitation.	Baseline and end of the study after 30 sessions, an average of 6 weeks	The Arm disability was assessed of the study with the Quick version of the Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) questionnaire.; The Quick-DASH is a 19-item ordinal scale with a 5-level rating of items from 1 (no difficulty) to 5 (unable to do).; Quick-Dash can be divided into an 11-item (abilities and symptoms) and an 8-item optional work module and sports/performing arts module. In the 11-item sub-scale, the subject defines the ability to perform some actions (8 items) and the intensity of some symptoms (3 items), referring to the previous week. The total score range is from 19 (no disability) to 95 (full disability).