Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke

Fondazione Don Carlo Gnocchi ETS32 enrolled

Overview

Among robotic devices, Gloreha, with its compliant mechanical transmission, may represent an easily applied innovative solution to rehabilitation, because the hand can perform grasp and release activities wearing the device by mean of a flexible and light orthosis. Our objective on this research was to the robotic assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis.

The investigators evaluated the effectiveness of a robotic-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis. A randomized controlled trial. The experimental group received a passive mobilization of the hand through the robotic device Gloreha and control group received a PT and OT for 3 consecutive weeks (3 days/week) in addition to traditional rehabilitation. Outcomes included the National Institutes of Health Stroke Scale (NIHSS), Modified Ashworth Scale (MAS), Barthel index (BI), Motricity index (MI), short version of the Disabilities of the Arm, Shoulder and Hand (quickDASH), and the Visual Analogue Scale (VAS) measurements. All measures were collected at baseline and end of the intervention (3 weeks).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Stroke

Interventions

Experimental groupDEVICE

Robotic assisted passive mobilization (Gloreha, Idrogenet, Italy) and traditional rehabilitation.

Control groupDEVICE

Physiotherapy and occupational therapy.

traditional rehabilitationDEVICE

Assisted stretching, shoulder and arm exercises, and functional reaching tasks

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * acute phase of stroke * first stroke episode. * no history of peripheral nerve injury or musculoskeletal disease * no contracture of the affected wrist or fingers (Modified Ashworth\<3) * no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months prior to the start of this study. * paralysis of the wrist and fingers Exclusion Criteria: * unstable medical disorders, active Complex Regional Pain Syndrome (CRPS) severe spatial neglect, aphasia, or cognitive problems. * scored greater than 4 points on the Beck Depression Inventory (BDI) * more than 30 points in the State Trait Anxiety Inventory (STAI)

Outcomes

Primary Outcomes

Change from National Institutes of Health Stroke Scale (NIHSS)

Time frame: baseline, immediately post-intervention (3 weeks).

Secondary Outcomes

Change from Visual analogue scale (VAS)

Time frame: baseline, immediately post-intervention (3 weeks).

Change from Barthel Index (BI)

Time frame: baseline, immediately post-intervention (3 weeks).

Change from Modified Ashworth Scale (MAS)

Time frame: baseline, immediately post-intervention

Change from Disabilities of the Arm, Shoulder and Hand (quickDASH)

Time frame: baseline, immediately post-intervention (3 weeks).

Data from ClinicalTrials.gov

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