Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke

March 11, 2016 updated by: Jorge Hugo Villafañe, PhD, Fondazione Don Carlo Gnocchi Onlus

Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: a Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Robotic device Gloreha (Gloreha, Idrogenet, Italy) and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).
Device: Experimental group
Robotic assisted passive mobilization (Gloreha, Idrogenet, Italy) and traditional rehabilitation.
Device: traditional rehabilitation
Assisted stretching, shoulder and arm exercises, and functional reaching tasks
Active Comparator: Control group
Physiotherapy, occupational therapy and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).
Device: traditional rehabilitation
Assisted stretching, shoulder and arm exercises, and functional reaching tasks
Device: Control group
Physiotherapy and occupational therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from National Institutes of Health Stroke Scale (NIHSS)
Time Frame: baseline, immediately post-intervention (3 weeks).
baseline, immediately post-intervention (3 weeks).

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Investigators

  • Principal Investigator: JORGE H VILLAFAÑE, PhD, IRCCS Don Gnocchi Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 5, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 11, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Project Code:RC-2015-Gloreha

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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