Using Tablets for Upper Extremity Rehabilitation Post Acquired Brain Injury (TBL)

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 Overview

• Status: Unknown
• Conditions: Stroke; Brain Injury
• Intervention / Treatment: Device: Tablet - self exercise; Other: GRASP self exercise

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Recruiting
    • Sheba Medical Center
    • Sub-Investigator: Rachel Kizony, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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.	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

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	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	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	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	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	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	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	Mean self-training time per day.	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.	An average of one week after intervention

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: Tel-Aviv Sourasky Medical Center
• Investigators: Study Chair: Rachel Kizony, PhD, Sheba

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ANTICIPATED): August 1, 2015

Study Registration Dates

• First Submitted: September 2, 2013
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (ESTIMATE): May 13, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): September 18, 2014
• Last Update Submitted That Met QC Criteria: September 17, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Hand; Tablet; Brain-injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: SHEBA-13-0125-RK-CTIL