Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation

Completed

Phase N/A Results

Trial Description

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.

Conditions

Interventions

  • General Rehabilitation Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Gloreha Group
    Description: The patients in the "Gloreha Group" underwent to following interventions: General Rehabilitation Specific hand rehabilitation by Gloreha device
    ARM 2: Kind: Experimental
    Label: Control Group
    Description: The patients in the Control Group underwent to following interventions: General Rehabilitation Specific hand rehabilitation performed by physiotherapist
  • Specific hand rehabilitation by Gloreha device Device
    Intervention Desc: Each training session consisted of six parts: A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 7 min of a number sequence (counting from one to five); A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) A sequence of wave-like finger movements (7 min) A sequence of fist opening/closing (7 min) A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).
    ARM 1: Kind: Experimental
    Label: Gloreha Group
    Description: The patients in the "Gloreha Group" underwent to following interventions: General Rehabilitation Specific hand rehabilitation by Gloreha device
  • Specific hand rehabilitation performed by physiotherapist Other
    Intervention Desc: The activities were: Flexion-extension of the fingers (10 min); Thumb opposition with the other fingers keeping the forearm in supine position (10 min); Adduction and abduction of the fingers (10 min); 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).
    ARM 1: Kind: Experimental
    Label: Control Group
    Description: The patients in the Control Group underwent to following interventions: General Rehabilitation Specific hand rehabilitation performed by physiotherapist

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of patients who completed the hand rehabilitation program using a new neuromotor rehabilitation device (Gloreha) 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. No
Primary 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. Yes
Primary Efficacy in improving arm function abilities measured by Motricity Index Change from baseline Motricity Index at the end of the inpatient rehabilitation (through study completion, after 30 sessions and an average of 6 weeks) No
Primary Efficacy in improving arm function abilities measured by Nine Hole Peg Test Change from baseline Motricity Index at the end of the inpatient rehabilitation (through study completion, after 30 sessions and an average of 6 weeks) No
Secondary The feasibility of this new neuromotor rehabilitation device (Gloreha) 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. No
Secondary Efficacy in improving arm function abilities measured by the Grip test Change from baseline Grip test at the end of the inpatient rehabilitation (through study completion, after 30 sessions and an average of 6 weeks) No
Secondary Efficacy in improving arm function abilities measured by the Pinch test Change from baseline Pinch test at the end of the inpatient rehabilitation (through study completion, after 30 sessions and an average of 6 weeks) No
Secondary Efficacy in improving arm function abilities measured by the Quick-DASH questionnaire Change from baseline Quick-DASH at the end of the inpatient rehabilitation (through study completion, after 30 sessions and an average of 6 weeks) No
Secondary 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. No
Primary 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. No
Primary Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Motricity Index at End of Inpatient Rehabilitation Delta improvement (posttest -pretest) of Motricity Index No
Primary Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Nine Hole Peg Test at End of Inpatient Rehabilitation. Delta improvement (posttest -pretest) of NHPT No
Secondary Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Grip Test at End of Inpatient Rehabilitation. Delta improvement (posttest -pretest) of Grip test No
Secondary Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Pinch Test at End of Inpatient Rehabilitation. Delta improvement (posttest-pretest) of Pinch test No
Secondary Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Quick-DASH Questionnaire at End of Inpatient Rehabilitation. Delta improvement (posttest-pretest) of Quick-DASH. No

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