Using Tablets for Upper Extremity Rehabilitation Post Acquired Brain Injury

Stroke Clinical Trial

— TBL  

Official title:

Using Tablets for Upper Extremity Rehabilitation Post Acquired Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02136433
• Other study ID #: SHEBA-13-0125-RK-CTIL
• Status: Recruiting
• Phase: N/A
• First received: September 2, 2013
• Last updated: September 17, 2014
• Start date: February 2014

Study information

• Verified date: September 2014
• Source: Sheba Medical Center
• Contact: Gabi Zeilig, MD
• Phone: +972-3-5303725
• Email: gabi.zeilig[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Helsinki Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Stroke

Intervention

Device:
• Tablet - self exercise

Other:
• GRASP self exercise

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	Self - report compliance	Mean self-training time per day.	An average of one week after intervention	No
Secondary	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	No