Back to resultsUsing Tablets for Upper Extremity Rehabilitation Post Acquired Brain Injury (TBL)
Primary Purpose
Brain Injury, Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tablet - self exercise
GRASP self exercise
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injury focused on measuring Hand, Rehabilitation, Stroke, Brain-injury, Tablet
Eligibility Criteria
Inclusion Criteria:
- At least one week post Brain injury or stroke
- Partial ability to open and close their hand (fingers)
- Full function of the hands prior to the injury or event
- Intact or Corrected vision
- Cognitively intact or mild impairment
Exclusion Criteria:
- Other neurological conditions besides the brain injury or stroke
- Orthopedic conditions of the upper extremity
Sites / Locations
- Sheba Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tablet - self exercise
GRASP self exercise
Arm Description
Existing tablet Apps that encourage finger movement in a fun manner while playing a game will be used. The apps will be taught to the participants and then they will be requested to exercise alone (or with family) everyday for one hour in addition to their regular rehabilitation sessions (Occupational, Physical Therapy, speech). The intervention will include 15-20 sessions of 60 minutes of self-training using a tablet.
GRASP (Graded Repetitive Arm Supplementary Program)(Harris et al., 2009)is an arm and hand exercise program developed for individuals with stroke with upper extremity impairments GRASP provides a method for patients to undertake a self-directed arm and hand exercise program. The exercises will be taught to the participants and then they will be requested to exercise alone (or with family) everyday for one hour in addition to their regular rehabilitation sessions (Occupational, Physical Therapy, speech). The intervention will include 15-20 sessions of 60 minutes of self-training
Outcomes
Primary Outcome Measures
Change from baseline in score of the Nine Hole Peg Test
To assess dexterity of the affected hand. This test is a assesses dexterity and the time to remove and return nine pegs is measured. The Nine Hole Peg Test is a reliable, valid and responsive measure in clients with stroke
Secondary Outcome Measures
The Fugl-Meyer Motor Assessment
To quantify the level of the motor impairment. The participants are required to perform different movements. Each movement is rated 0 (inability to perform) to 2 (full movement). The total score ranges from 0 (no active movements) to 60 points (full movements).
Grip and pinch strength
Assessed by the Jamar dynamometer. This is a valid and reliable way to assess grip and pinch strength of individuals recovering from stroke.
Visual Analogue Scale
Quantifies the perceived level of pain intensity on a scale of 0-10 cm.
The System Usability Scale
This questionnaire includes 10 items which provide a global view of subjective assessment of a system's usability.
Change from baseline in score of the Action Research Arm Test
Assesses the functional ability of the upper extremity by grasping and moving objects of different size and weight. It has four subtests; grasp, grip, pinch and gross movement. The total score is out of 57 points.
Self - report compliance
Mean self-training time per day.
Satisfaction Questionnaire
Developed for the study and will query how much the subjects were satisfied with the self-training intervention they experienced and to what extent they think it can help them to improve their upper extremity function. Responses will be rated on a scale of 1-5.
Full Information
NCT ID
NCT02136433
First Posted
September 2, 2013
Last Updated
September 17, 2014
Sponsor
Sheba Medical Center
Collaborators
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02136433
Brief Title
Using Tablets for Upper Extremity Rehabilitation Post Acquired Brain Injury
Acronym
TBL
Official Title
Using Tablets for Upper Extremity Rehabilitation Post Acquired Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
Collaborators
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to test the effectiveness of training using novel tablet applications for hand function, compared to traditional hand exercises. In addition, we aim to examine brain plasticity following treatment with the new tablet applications. We hypothesize that training with a tablet would prove to be more effective than traditional exercises. We expect to observe neuroplastic changes in the brain in patients who practiced finger movements using the tablet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury, Stroke
Keywords
Hand, Rehabilitation, Stroke, Brain-injury, Tablet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tablet - self exercise
Arm Type
Experimental
Arm Description
Existing tablet Apps that encourage finger movement in a fun manner while playing a game will be used. The apps will be taught to the participants and then they will be requested to exercise alone (or with family) everyday for one hour in addition to their regular rehabilitation sessions (Occupational, Physical Therapy, speech).
The intervention will include 15-20 sessions of 60 minutes of self-training using a tablet.
Arm Title
GRASP self exercise
Arm Type
Active Comparator
Arm Description
GRASP (Graded Repetitive Arm Supplementary Program)(Harris et al., 2009)is an arm and hand exercise program developed for individuals with stroke with upper extremity impairments GRASP provides a method for patients to undertake a self-directed arm and hand exercise program.
The exercises will be taught to the participants and then they will be requested to exercise alone (or with family) everyday for one hour in addition to their regular rehabilitation sessions (Occupational, Physical Therapy, speech).
The intervention will include 15-20 sessions of 60 minutes of self-training
Intervention Type
Device
Intervention Name(s)
Tablet - self exercise
Intervention Type
Other
Intervention Name(s)
GRASP self exercise
Primary Outcome Measure Information:
Title
Change from baseline in score of the Nine Hole Peg Test
Description
To assess dexterity of the affected hand. This test is a assesses dexterity and the time to remove and return nine pegs is measured. The Nine Hole Peg Test is a reliable, valid and responsive measure in clients with stroke
Time Frame
An average of one week before intervention and one week after intervention
Secondary Outcome Measure Information:
Title
The Fugl-Meyer Motor Assessment
Description
To quantify the level of the motor impairment. The participants are required to perform different movements. Each movement is rated 0 (inability to perform) to 2 (full movement). The total score ranges from 0 (no active movements) to 60 points (full movements).
Time Frame
An average of one week before intervention and one week after intervention
Title
Grip and pinch strength
Description
Assessed by the Jamar dynamometer. This is a valid and reliable way to assess grip and pinch strength of individuals recovering from stroke.
Time Frame
An average of one week before intervention and one week after intervention
Title
Visual Analogue Scale
Description
Quantifies the perceived level of pain intensity on a scale of 0-10 cm.
Time Frame
An average of one week before intervention and one week after intervention
Title
The System Usability Scale
Description
This questionnaire includes 10 items which provide a global view of subjective assessment of a system's usability.
Time Frame
An average of one week after intervention
Title
Change from baseline in score of the Action Research Arm Test
Description
Assesses the functional ability of the upper extremity by grasping and moving objects of different size and weight. It has four subtests; grasp, grip, pinch and gross movement. The total score is out of 57 points.
Time Frame
An average of one week before intervention and one week after intervention
Title
Self - report compliance
Description
Mean self-training time per day.
Time Frame
An average of one week after intervention
Title
Satisfaction Questionnaire
Description
Developed for the study and will query how much the subjects were satisfied with the self-training intervention they experienced and to what extent they think it can help them to improve their upper extremity function. Responses will be rated on a scale of 1-5.
Time Frame
An average of one week after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least one week post Brain injury or stroke
Partial ability to open and close their hand (fingers)
Full function of the hands prior to the injury or event
Intact or Corrected vision
Cognitively intact or mild impairment
Exclusion Criteria:
Other neurological conditions besides the brain injury or stroke
Orthopedic conditions of the upper extremity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabi Zeilig, MD
Phone
+972-3-5303725
Email
gabi.zeilig@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Kizony, PhD
Organizational Affiliation
Sheba
Official's Role
Study Chair
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Kizony, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
26081864
Citation
Rand D, Zeilig G, Kizony R. Rehab-let: touchscreen tablet for self-training impaired dexterity post stroke: study protocol for a pilot randomized controlled trial. Trials. 2015 Jun 18;16:277. doi: 10.1186/s13063-015-0796-9.
Results Reference
derived
Learn more about this trial
Using Tablets for Upper Extremity Rehabilitation Post Acquired Brain Injury
We'll reach out to this number within 24 hrs