Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental group
Control group
traditional rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Hand, Paralysis, Stroke
Eligibility Criteria
Inclusion Criteria:
- acute phase of stroke
- first stroke episode.
- no history of peripheral nerve injury or musculoskeletal disease
- 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 prior to the start of this study.
- paralysis of the wrist and fingers
Exclusion Criteria:
- unstable medical disorders, active Complex Regional Pain Syndrome (CRPS) severe spatial neglect, aphasia, or cognitive problems.
- scored greater than 4 points on the Beck Depression Inventory (BDI)
- more than 30 points in the State Trait Anxiety Inventory (STAI)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Robotic device Gloreha (Gloreha, Idrogenet, Italy) and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).
Physiotherapy, occupational therapy and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).
Outcomes
Primary Outcome Measures
Change from National Institutes of Health Stroke Scale (NIHSS)
Secondary Outcome Measures
Change from Visual analogue scale (VAS)
Change from Barthel Index (BI)
Change from Modified Ashworth Scale (MAS)
Change from Disabilities of the Arm, Shoulder and Hand (quickDASH)
Full Information
NCT ID
NCT02711787
First Posted
March 5, 2016
Last Updated
March 11, 2016
Sponsor
Fondazione Don Carlo Gnocchi Onlus
1. Study Identification
Unique Protocol Identification Number
NCT02711787
Brief Title
Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke
Official Title
Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Among robotic devices, Gloreha, with its compliant mechanical transmission, may represent an easily applied innovative solution to rehabilitation, because the hand can perform grasp and release activities wearing the device by mean of a flexible and light orthosis. Our objective on this research was to the robotic assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis.
Detailed Description
The investigators evaluated the effectiveness of a robotic-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis. A randomized controlled trial. The experimental group received a passive mobilization of the hand through the robotic device Gloreha and control group received a PT and OT for 3 consecutive weeks (3 days/week) in addition to traditional rehabilitation. Outcomes included the National Institutes of Health Stroke Scale (NIHSS), Modified Ashworth Scale (MAS), Barthel index (BI), Motricity index (MI), short version of the Disabilities of the Arm, Shoulder and Hand (quickDASH), and the Visual Analogue Scale (VAS) measurements. All measures were collected at baseline and end of the intervention (3 weeks).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Hand, Paralysis, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Robotic device Gloreha (Gloreha, Idrogenet, Italy) and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Physiotherapy, occupational therapy and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).
Intervention Type
Device
Intervention Name(s)
Experimental group
Intervention Description
Robotic assisted passive mobilization (Gloreha, Idrogenet, Italy) and traditional rehabilitation.
Intervention Type
Device
Intervention Name(s)
Control group
Intervention Description
Physiotherapy and occupational therapy.
Intervention Type
Device
Intervention Name(s)
traditional rehabilitation
Intervention Description
Assisted stretching, shoulder and arm exercises, and functional reaching tasks
Primary Outcome Measure Information:
Title
Change from National Institutes of Health Stroke Scale (NIHSS)
Time Frame
baseline, immediately post-intervention (3 weeks).
Secondary Outcome Measure Information:
Title
Change from Visual analogue scale (VAS)
Time Frame
baseline, immediately post-intervention (3 weeks).
Title
Change from Barthel Index (BI)
Time Frame
baseline, immediately post-intervention (3 weeks).
Title
Change from Modified Ashworth Scale (MAS)
Time Frame
baseline, immediately post-intervention
Title
Change from Disabilities of the Arm, Shoulder and Hand (quickDASH)
Time Frame
baseline, immediately post-intervention (3 weeks).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
acute phase of stroke
first stroke episode.
no history of peripheral nerve injury or musculoskeletal disease
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 prior to the start of this study.
paralysis of the wrist and fingers
Exclusion Criteria:
unstable medical disorders, active Complex Regional Pain Syndrome (CRPS) severe spatial neglect, aphasia, or cognitive problems.
scored greater than 4 points on the Beck Depression Inventory (BDI)
more than 30 points in the State Trait Anxiety Inventory (STAI)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JORGE H VILLAFAÑE, PhD
Organizational Affiliation
IRCCS Don Gnocchi Foundation
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke
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