ClinicalTrials.gg
Status unknownNCT02136433TBLUpdated Sep 18, 2014

Using Tablets for Upper Extremity Rehabilitation Post Acquired Brain Injury

An interventional study of Tablet - self exercise and GRASP self exercise in Brain Injury and Stroke, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-09-18.

Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Brain Injury
  • Stroke

Keywords

  • Hand
  • Rehabilitation
  • Stroke
  • Brain-injury
  • Tablet
03

In context

Brain Injuries

2,125 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.

This study's planned enrollment of 40 is below the median of 48 across 1,341 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 677 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Other neurological conditions besides the brain injury or stroke
  • Orthopedic conditions of the upper extremity
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • 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.

    Device: Tablet - self exercise

  • 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

    Other: GRASP self exercise

Interventions

  • DeviceTablet - self exercise
  • OtherGRASP self exercise
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: An average of one week before intervention and one week after intervention

Secondary outcomes

  1. 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).

    Time frame: An average of one week before intervention and one week after intervention

  2. 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.

    Time frame: An average of one week before intervention and one week after intervention

  3. Visual Analogue Scale

    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

  4. The System Usability Scale

    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

  5. 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.

    Time frame: An average of one week before intervention and one week after intervention

  6. Self - report compliance

    Mean self-training time per day.

    Time frame: An average of one week after intervention

  7. 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.

    Time frame: An average of one week after intervention

07

Study locations

1 of 1 sites recruiting
  • Sheba Medical Center
    Ramat Gan, Israel
    • Rachel Kizony, PhD · Sub investigator
    Recruiting
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2014 and a primary completion of Aug 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2013
First posted
May 13, 2014
Start
Feb 2014
Primary completionEst.
Aug 2015
Last update
Sep 18, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02136433
Responsible party
Sponsor
First posted
May 13, 2014
Start date
Feb 2014
Primary completion
Aug 2015 (estimated)
Last update
Sep 18, 2014

Study contacts

Gabi Zeilig, MD
Contact
gabi.zeilig@sheba.health.gov.il
+972-3-5303725
Rachel Kizony, PhD
study chair · Sheba

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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