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

Not Applicable

• Conditions: Stroke
• Interventions: Device: EMG and TENS; Device: TENS only

• Registration Number: NCT03146559
• Lead Sponsor: Nachum Soroker, MD

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.

Study Timeline

• Study First Submitted: 2017-05-07
• Study First Submitted QC: 2017-05-07
• Study First Posted: 2017-05-10
• Study Start: 2017-05-25
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-24
• Last Update Posted: 2017-08-25
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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

Exclusion Criteria

• Unstable clinical/metabolic state

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMG and TENS	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.
TENS only	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.

Primary Outcome Measures

Name	Time	Method
Change in active range of motion of wrist dorsi flexion and fingers extension	Baseline, after 3 weeks of intervention and one month after the end of the intervention (follow up).	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Loewenstain hospital; 🇮🇱 Raanana, Israel