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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Device: EMG and TENS; Device: TENS only

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.

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Raanana, Israel
    • Recruiting
    • Loewenstain hospital
    • Contact: Nachum Soroker, MD; Email: nachums@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Unstable clinical/metabolic state

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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.	Device: TENS only; Automatic TENS stimuli to the paretic dorsi flexors (i.e., producing wrist dorsi flexion).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fugl-Meyer Assessment	Score of 66 point indicate normal motor functioning of upper limb	Baseline, after 3 weeks of intervention and one month after the end of the intervention (follow up).
Change in Box and Blocks test	Number of cubes transferred from one side of cube (chamber) to the other side of the cube within a minute	Baseline, after 3 weeks of intervention and one month after the end of the intervention (follow up).
Change in Jebsen Taylor Hand Function Test	Time of performance of different task, mimicking activity of daily living, is measured.	Baseline, after 3 weeks of intervention and one month after the end of the intervention (follow up).

Collaborators and Investigators

• Sponsor: Nachum Soroker, MD
• Collaborators: Tel Aviv University

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: May 7, 2017
• First Submitted That Met QC Criteria: May 7, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 24, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: EMG; Cross education
• Other Study ID Numbers: loe003516CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No