Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Control group; Device: Experimental group; Device: traditional rehabilitation

• Registration Number: NCT02711787
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2014-07
• Primary Completion: 2015-02
• Study Completion: 2015-06
• Status Verified: 2016-03
• Study First Submitted: 2016-03-05
• Study First Submitted QC: 2016-03-11
• Last Update Submitted: 2016-03-11
• Study First Posted: 2016-03-17
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	Physiotherapy, occupational therapy and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).
Control group	traditional rehabilitation	Physiotherapy, occupational therapy and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).
Experimental group	Experimental group	Robotic device Gloreha (Gloreha, Idrogenet, Italy) and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).
Experimental group	traditional rehabilitation	Robotic device Gloreha (Gloreha, Idrogenet, Italy) and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).

Primary Outcome Measures

Name	Time	Method
Change from National Institutes of Health Stroke Scale (NIHSS)	baseline, immediately post-intervention (3 weeks).

Secondary Outcome Measures

Name	Time	Method
Change from Visual analogue scale (VAS)	baseline, immediately post-intervention (3 weeks).
Change from Barthel Index (BI)	baseline, immediately post-intervention (3 weeks).
Change from Disabilities of the Arm, Shoulder and Hand (quickDASH)	baseline, immediately post-intervention (3 weeks).
Change from Modified Ashworth Scale (MAS)	baseline, immediately post-intervention