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

Sponsor
Chiara Mulé (Other)
Overall Status
Completed
CT.gov ID
NCT01936298
Collaborator
(none)
35
Enrollment
1
Location
2
Arms
30
Duration (Days)
35.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: A-ROM Continuous Passive Rehabilitation
  • Device: P-ROM Continuous Passive Rehabilitation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Oct 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline of Perimeter edema [1 day after the treatment]

    Secondary Outcome Measures

    1. Change from Baseline of Visual analogue scale (VAS) [1 day after the treatment]

    2. Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS) [1 day after the treatment]

    3. Change from Baseline of Range Of Motion (ROM) [1 day after the treatment]

    4. Clinical Global Impression (CGI) [1 day after the treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Habilita, Ospedale di Sarnico Sarnico Bergamo Italy 24067

    Sponsors and Collaborators

    • Chiara Mulé

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Chiara Mulé, Physiatrist Physician, Habilita, Ospedale di Sarnico
    ClinicalTrials.gov Identifier:
    NCT01936298
    Other Study ID Numbers:
    • GLO01
    First Posted:
    Sep 6, 2013
    Last Update Posted:
    Oct 28, 2013
    Last Verified:
    Oct 1, 2013
    Keywords provided by Chiara Mulé, Physiatrist Physician, Habilita, Ospedale di Sarnico
    Hand Edema
    Exercise Therapy
    Additional relevant MeSH terms:
    Stroke
    Paralysis

    Study Results

    No Results Posted as of Oct 28, 2013