Brain InjuryTBLNCT02136433
Using Tablets for Upper Extremity Rehabilitation Post Acquired Brain Injury
A study testing Tablet - self exercise and GRASP self exercise in people with Brain Injury and Stroke, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Brain Injury, Stroke
- What is being tested?
- Tablet - self exercise and GRASP self exercise
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Other neurological conditions besides the brain injury or stroke
- Orthopedic conditions of the upper extremity
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Rachel Kizony, PhD
About this study
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.
- Conditions
- Brain Injury, Stroke
- Being tested
- Tablet - self exercise, GRASP self exercise
- Keywords
- Hand, Rehabilitation, Stroke, Brain-injury, Tablet
- Medical subject headings
- Brain Injuries, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet - self exerciseDevice
GRASP self exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Tablet - self exercise | Experimental | 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. Receives: Device: Tablet - self exercise |
| GRASP self exercise | Active comparator | 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 Receives: Other: GRASP self exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: An average of one week before intervention and one week after intervention
Secondary outcomes (7)
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).
Measured: An average of one week before intervention and one week after intervention
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.
Measured: An average of one week before intervention and one week after intervention
Visual Analogue Scale
Quantifies the perceived level of pain intensity on a scale of 0-10 cm.
Measured: An average of one week before intervention and one week after intervention
The System Usability Scale
This questionnaire includes 10 items which provide a global view of subjective assessment of a system's usability.
Measured: An average of one week after intervention
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.
Measured: An average of one week before intervention and one week after intervention
Self - report compliance
Mean self-training time per day.
Measured: An average of one week after intervention
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.
Measured: An average of one week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Responsible party
- Sponsor
- Investigators
- Rachel Kizony, PhD, Study chair, Sheba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136433
- Sponsor's protocol ID
- SHEBA-13-0125-RK-CTIL
- Acronym
- TBL
- Status last verified
- Sep 2014
- First submitted
- 2 Sep 2013
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26081864
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Tablets for Upper Extremity Rehabilitation Post Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT02136433
- Acronym / sponsor ID
- TBL / SHEBA-13-0125-RK-CTIL
- Conditions
- Brain Injury, Stroke
- Keywords
- Hand, Rehabilitation, Stroke, Brain-injury, Tablet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Study start
- Feb 2014
- Primary completion
- Aug 2015 (estimated)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet - self exercise | Experimental | Device: Tablet - self exerciseExisting 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 self exercise | Active comparator | Other: GRASP self exerciseGRASP (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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Other neurological conditions besides the brain injury or stroke
- Orthopedic conditions of the upper extremity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tablet - self exercise | Device | Tablet - self exercise |
| GRASP self exercise | Other | GRASP self exercise |
Primary outcome
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
7 secondary outcomes
The Fugl-Meyer Motor Assessment
Time frame: 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
Visual Analogue Scale
Time frame: 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
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
Self - report compliance
Time frame: An average of one week after intervention
Satisfaction Questionnaire
Time frame: An average of one week after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
- Derived from this study: PubMed 26081864Rand 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Kizony, PhD study chair
Sheba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet - self exercise and GRASP self exercise in people with Brain Injury and Stroke, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabi Zeilig, MD (+972-3-5303725, gabi.zeilig@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02136433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2014.