Back to resultsRobot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
A-ROM Continuous Passive Rehabilitation
P-ROM Continuous Passive Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Hand Edema, Exercise Therapy
Eligibility 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.
Sites / Locations
- Habilita, Ospedale di Sarnico
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A-ROM Continuous Passive Rehabilitation
P-ROM Continuous Passive Rehabilitation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from Baseline of Perimeter edema
Secondary Outcome Measures
Change from Baseline of Visual analogue scale (VAS)
Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS)
Change from Baseline of Range Of Motion (ROM)
Clinical Global Impression (CGI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01936298
Brief Title
Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke
Official Title
Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chiara Mulé
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Hand Edema, Exercise Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A-ROM Continuous Passive Rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
P-ROM Continuous Passive Rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
A-ROM Continuous Passive Rehabilitation
Other Intervention Name(s)
Continuous Passive Motion device for hand: Gloreha
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
P-ROM Continuous Passive Rehabilitation
Other Intervention Name(s)
Continuous Passive Motion device for hand: Gloreha
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from Baseline of Perimeter edema
Time Frame
1 day after the treatment
Secondary Outcome Measure Information:
Title
Change from Baseline of Visual analogue scale (VAS)
Time Frame
1 day after the treatment
Title
Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS)
Time Frame
1 day after the treatment
Title
Change from Baseline of Range Of Motion (ROM)
Time Frame
1 day after the treatment
Title
Clinical Global Impression (CGI)
Time Frame
1 day after the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiara Mulé, MD
Organizational Affiliation
Habilita, Ospedale di Sarnico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Habilita, Ospedale di Sarnico
City
Sarnico
State/Province
Bergamo
ZIP/Postal Code
24067
Country
Italy
12. IPD Sharing Statement
Citations:
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21964036
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Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke
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