Using EMG of the Healthy Hand to Control TENS of the Affected Hand in Hemiparetic Patients

NCT ID: NCT03146559

Last Updated: 2017-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-25
• Study Completion Date: 2018-05-31

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.

Detailed Description

14 post-stroke subjects will be recruited from neurological rehabilitation department at Loewenstein rehabilitation hospital, Ra'anana, Israel. The patients will be randomly assigned to one of two groups: 1) Experimental group. 2) Control group. The 3 weeks intervention (15 sessions) in each group will include electric muscles stimuli (pulse rate 35-100Hz pulse width 200 microseconds, 5 sec on and 10 sec rest ) of the hemiparetic hand for 15 minutes. The patients in the experimental group will wear a wireless Bluetooth EMG ("Myo" bracelet) on their healthy forearm and when they will execute wrist dorsi flexion, the data will be transmitted to a PC which will be used to activate (via Arduino controller) a Transcutaneous Electric Nerve Stimulator (TENS) that is attached to the paretic dorsi flexors (electrodes are placed on the paretic forearm). The control group will get only automatic stimuli on the paretic forearm via the TENS.

The assessments will be done before the intervention, at the end of three weeks of intervention, and after 1 month from the end of the intervention (follow up).

The outcomes will include: active range of motion of fingers and wrist dorsi flexion (using cybermin 5DT glove for digital measures), upper limb section of Fugl-Meyer test, Box and Blocks test and Jebsen Taylor Hand Function Test. Only before the beginning of the intervention the sensory ability of the patient will be assessed using the Sensory section of Fugl-Meyer (FM) and Semmes-Weinstein filaments for superficial sensation. Normalized lesion data will be computed using the ABLE module within MEDx software (Medical Numerics).

Differences between groups will be calculated using t-tests or Mann-Whitney, depending on distribution of normality with corrections for multiple comparisons.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EMG and TENS

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.

Group Type: EXPERIMENTAL

EMG and TENS

Intervention Type: DEVICE

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.

TENS only

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.

Group Type: ACTIVE_COMPARATOR

TENS only

Intervention Type: DEVICE

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

Interventions

EMG and TENS

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.

Intervention Type: DEVICE

TENS only

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Unstable clinical/metabolic state

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel Aviv University

OTHER

Sponsor Role: collaborator

Nachum Soroker, MD

OTHER

Sponsor Role: lead

Responsible Party

Nachum Soroker, MD

head, Department of neurologic rehabilitation, Loewenstein

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sivi Frenkel-Toledo, PhD

Role: STUDY_DIRECTOR

Loewenstein Hospital

Locations

Loewenstain hospital

Raanana, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Silvi Frenkel-Toledo

Role: CONTACT

silvi197@bezeqint.net

972545509413

Nachum Soroker, MD

Role: CONTACT

Facility Contacts

Nachum Soroker, MD

Role: primary

nachums@clalit.org.il

Silvi Frenkel-Toledo, PhD

Role: backup

silvi197@bezeqint.net

972545509413

Other Identifiers

loe003516CTIL

Identifier Type: -

Identifier Source: org_study_id