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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiara Mulé, Habilita, Ospedale di Sarnico
ClinicalTrials.gov Identifier:
NCT01936298
First received: September 2, 2013
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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 Intervention
Stroke
Device: A-ROM Continuous Passive Rehabilitation
Device: P-ROM Continuous Passive Rehabilitation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke

Resource links provided by NLM:


Further study details as provided by Habilita, Ospedale di Sarnico:

Primary Outcome Measures:
  • Change from Baseline of Perimeter edema [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline of Visual analogue scale (VAS) [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]
  • Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS) [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]
  • Change from Baseline of Range Of Motion (ROM) [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]
  • Clinical Global Impression (CGI) [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: September 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Chiara Mulé, Physiatrist Physician, Habilita, Ospedale di Sarnico
ClinicalTrials.gov Identifier: NCT01936298     History of Changes
Other Study ID Numbers: GLO01
Study First Received: September 2, 2013
Last Updated: October 25, 2013
Health Authority: Italy: Ministry of Health

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

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 16, 2014