NCT03146559

Brief Summary

The purpose of this study is to investigate learning transfer from the healthy hand to the paretic hand in stroke patients. EMG signals from the healthy hand - while performing wrist dorsi flexion movement - will be used to activate electric muscles stimulation of the dorsi flexors of the paretic hand.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable stroke

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

May 25, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

May 7, 2017

Last Update Submit

August 24, 2017

Conditions

Stroke

Keywords

Cross educationEMG

Outcome Measures

Primary Outcomes (1)

  • Change in active range of motion of wrist dorsi flexion and fingers extension

    The ability of the paretic hand to produce active range of motion (ROM) of paretic fingers and wrist by using digital measurements with 5DT Cybermin glove.

    Baseline, after 3 weeks of intervention and one month after the end of the intervention (follow up).

Secondary Outcomes (3)

  • Change in Fugl-Meyer Assessment

    Baseline, after 3 weeks of intervention and one month after the end of the intervention (follow up).

  • Change in Box and Blocks test

    Baseline, after 3 weeks of intervention and one month after the end of the intervention (follow up).

  • Change in Jebsen Taylor Hand Function Test

    Baseline, after 3 weeks of intervention and one month after the end of the intervention (follow up).

Study Arms (2)

EMG and TENS

EXPERIMENTAL

Wireless Bluetooth EMG ("Myo") bracelet will be placed on the healthy forearm. A voluntary dorsi flexion of the healthy wrist produces data that will be transmitted to a PC and will be used to activate (via Arduino controller) a Transcutaneous Electric Nerve Stimulator (TENS), placed on the paretic forearm, that will stimulate wrist dorsi flexors. 5 days per week, for 3 weeks, 15 minutes per day.

Device: EMG and TENS

TENS only

ACTIVE COMPARATOR

Custom-built software \& hardware: PC + Arduino controller and Transcutaneous Electric Nerve Stimulator (TENS) device, will be used to stimulate wrist dorsi flexors of the paretic forearm. 5 days per week, for 3 weeks, 15 minutes per day.

Device: TENS only

Interventions

EMG and TENSDEVICE

Healthy hand EMG signal measured while making voluntarily wrist dorsi flexion will activate TENS, which will be placed on the paretic forearm and will produce wrist dorsi flexion.

EMG and TENS
TENS onlyDEVICE

Automatic TENS stimuli to the paretic dorsi flexors (i.e., producing wrist dorsi flexion).

TENS only

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First stroke
  • Age 25-80 years
  • Able to understand research instructions

You may not qualify if:

  • Unstable clinical/metabolic state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loewenstain hospital

Raanana, Israel

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

ElectromyographyTranscutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyographyElectric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Sivi Frenkel-Toledo, PhD

    Loewenstein Hospital

    STUDY DIRECTOR

Central Study Contacts

Silvi Frenkel-Toledo

CONTACT

972545509413silvi197@bezeqint.net

Nachum Soroker, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
head, Department of neurologic rehabilitation, Loewenstein

Study Record Dates

First Submitted

May 7, 2017

First Posted

May 10, 2017

Study Start

May 25, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

August 25, 2017

Record last verified: 2017-08

Locations

IL(1)