- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02136433
Using Tablets for Upper Extremity Rehabilitation Post Acquired Brain Injury (TBL)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gabi Zeilig, MD
- Phone Number: +972-3-5303725
- Email: gabi.zeilig@sheba.health.gov.il
Study Locations
-
-
-
Ramat Gan, Israel
- Recruiting
- Sheba Medical Center
-
Sub-Investigator:
- Rachel Kizony, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Tablet - self exercise
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. |
|
ACTIVE_COMPARATOR: GRASP self exercise
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in score of the Nine Hole Peg Test
Time Frame: An average of one week before intervention and one week after intervention
|
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
|
An average of one week before intervention and one week after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Fugl-Meyer Motor Assessment
Time Frame: An average of one week before intervention and one week after intervention
|
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).
|
An average of one week before intervention and one week after intervention
|
Grip and pinch strength
Time Frame: An average of one week before intervention and one week after intervention
|
Assessed by the Jamar dynamometer.
This is a valid and reliable way to assess grip and pinch strength of individuals recovering from stroke.
|
An average of one week before intervention and one week after intervention
|
Visual Analogue Scale
Time Frame: An average of one week before intervention and one week after intervention
|
Quantifies the perceived level of pain intensity on a scale of 0-10 cm.
|
An average of one week before intervention and one week after intervention
|
The System Usability Scale
Time Frame: An average of one week after intervention
|
This questionnaire includes 10 items which provide a global view of subjective assessment of a system's usability.
|
An average of one week after intervention
|
Change from baseline in score of the Action Research Arm Test
Time Frame: An average of one week before intervention and one week after intervention
|
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.
|
An average of one week before intervention and one week after intervention
|
Self - report compliance
Time Frame: An average of one week after intervention
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Mean self-training time per day.
|
An average of one week after intervention
|
Satisfaction Questionnaire
Time Frame: An average of one week after intervention
|
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.
|
An average of one week after intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Rachel Kizony, PhD, Sheba
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-13-0125-RK-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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