Using Tablets for Upper Extremity Rehabilitation Post Acquired Brain Injury

NCT ID: NCT02136433

Last Updated: 2014-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Injury Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Tablet - self exercise

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

GRASP self exercise

Intervention Type OTHER

Interventions

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Tablet - self exercise

Intervention Type DEVICE

GRASP self exercise

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel Kizony, PhD

Role: STUDY_CHAIR

Sheba

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Gabi Zeilig, MD

Role: CONTACT

+972-3-5303725

References

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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.

Reference Type DERIVED
PMID: 26081864 (View on PubMed)

Other Identifiers

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SHEBA-13-0125-RK-CTIL

Identifier Type: -

Identifier Source: org_study_id

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