Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke

October 25, 2013 updated by: Chiara Mulé
The investigators evaluate the effectiveness of the application of continuous passive motion device for hand rehabilitation in two classes of patients: with a residual active motion and without a residual active motion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We will conduct a double blind clinical trial. A sample size calculation were performed to determine the necessary number of subjects needed for this study and was based upon the results of a previous pilot study. All patients had functional impairments of their upper extremities after the stroke.

We hypothesized that the hand-rehabilitation oriented with robotics assistance, would improve edema by paralysis of the upper limb even in patient without sensory pathway recovery.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bergamo
      • Sarnico, Bergamo, Italy, 24067
        • Habilita, Ospedale di Sarnico

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

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a history of acute phase of stroke (less than 12 months post onset),
  • first stroke episode,
  • no history of peripheral nerve injury or musculoskeletal disease in the affected upper extremity,
  • 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 before the start of this study,
  • for P-ROM patients, the absence of active hand movements,
  • for the A-ROM patients, the presence of active hand movements.

Exclusion Criteria:

  • unstable medical disorders,
  • active Complex Regional Pain Syndrome (CRPS),
  • severe spatial neglect,
  • aphasia,
  • cognitive problems.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A-ROM Continuous Passive Rehabilitation
The group of patients with Active Range Of Motion (A-ROM) is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy.
Device: A-ROM Continuous Passive Rehabilitation
Half an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).
Other Names:
  • Continuous Passive Motion device for hand: Gloreha
Experimental: P-ROM Continuous Passive Rehabilitation
The group of patients with Passive Range Of Motion (P-ROM), i.e. without active movements of the hand at the baseline, is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy.
Device: P-ROM Continuous Passive Rehabilitation
Half an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).
Other Names:
  • Continuous Passive Motion device for hand: Gloreha

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline of Perimeter edema
Time Frame: 1 day after the treatment
1 day after the treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline of Visual analogue scale (VAS)
Time Frame: 1 day after the treatment
1 day after the treatment
Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS)
Time Frame: 1 day after the treatment
1 day after the treatment
Change from Baseline of Range Of Motion (ROM)
Time Frame: 1 day after the treatment
1 day after the treatment
Clinical Global Impression (CGI)
Time Frame: 1 day after the treatment
1 day after the treatment

Collaborators and Investigators

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

Sponsor

Chiara Mulé

Investigators

  • Principal Investigator: Chiara Mulé, MD, Habilita, Ospedale di Sarnico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

September 2, 2013

First Submitted That Met QC Criteria

September 2, 2013

First Posted (Estimate)

September 6, 2013

Study Record Updates

Last Update Posted (Estimate)

October 28, 2013

Last Update Submitted That Met QC Criteria

October 25, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLO01

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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