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

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ClinicalTrials.gov Identifier: NCT01936298
Recruitment Status : Completed
First Posted : September 6, 2013
Last Update Posted : October 28, 2013
Sponsor:
Information provided by (Responsible Party):
Chiara Mulé, Habilita, Ospedale di Sarnico

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
Stroke Device: A-ROM Continuous Passive Rehabilitation Device: P-ROM Continuous Passive Rehabilitation Not Applicable

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  (Clinical Trial)
Estimated 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 : September 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: Continuous Passive Motion device for hand: Gloreha



Primary Outcome Measures :
  1. Change from Baseline of Perimeter edema [ Time Frame: 1 day after the treatment ]

Secondary Outcome Measures :
  1. Change from Baseline of Visual analogue scale (VAS) [ Time Frame: 1 day after the treatment ]
  2. Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS) [ Time Frame: 1 day after the treatment ]
  3. Change from Baseline of Range Of Motion (ROM) [ Time Frame: 1 day after the treatment ]
  4. Clinical Global Impression (CGI) [ Time Frame: 1 day after the treatment ]


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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936298


Locations
Italy
Habilita, Ospedale di Sarnico
Sarnico, Bergamo, Italy, 24067
Sponsors and Collaborators
Chiara Mulé
Investigators
Principal Investigator: Chiara Mulé, MD Habilita, Ospedale di Sarnico

Publications:

Responsible Party: Chiara Mulé, Physiatrist Physician, Habilita, Ospedale di Sarnico
ClinicalTrials.gov Identifier: NCT01936298     History of Changes
Other Study ID Numbers: GLO01
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: October 28, 2013
Last Verified: October 2013

Keywords provided by Chiara Mulé, Habilita, Ospedale di Sarnico:
Hand Edema
Exercise Therapy

Additional relevant MeSH terms:
Stroke
Paralysis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms