NCT02136433

Brief 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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

September 18, 2014

Status Verified

September 1, 2014

Enrollment Period

1.5 years

First QC Date

September 2, 2013

Last Update Submit

September 17, 2014

Conditions

Brain InjuryStroke

Keywords

HandRehabilitationStrokeBrain-injuryTablet

Outcome Measures

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

    An average of one week before intervention and one week after intervention

Secondary Outcomes (7)

  • The Fugl-Meyer Motor Assessment

    An average of one week before intervention and one week after intervention

  • Grip and pinch strength

    An average of one week before intervention and one week after intervention

  • Visual Analogue Scale

    An average of one week before intervention and one week after intervention

  • The System Usability Scale

    An average of one week after intervention

  • Change from baseline in score of the Action Research Arm Test

    An average of one week before intervention and one week after intervention

  • +2 more secondary outcomes

Study Arms (2)

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.

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

Other: GRASP self exercise

Interventions

Tablet - self exerciseDEVICE
Tablet - self exercise
GRASP self exerciseOTHER
GRASP self exercise

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26081864DERIVED

MeSH Terms

Conditions

Brain InjuriesStroke

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Rachel Kizony, PhD

    Sheba

    STUDY CHAIR

Central Study Contacts

Gabi Zeilig, MD

CONTACT

+972-3-5303725gabi.zeilig@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2013

First Posted

May 13, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2015

Last Updated

September 18, 2014

Record last verified: 2014-09

Locations

IL(1)