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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03146559
• Other study ID #: loe003516CTIL
• Status: Recruiting
• Phase: N/A
• First received: May 7, 2017
• Last updated: August 24, 2017
• Start date: May 25, 2017
• Est. completion date: May 2018

Study information

• Verified date: August 2017
• Source: Loewenstein Hospital
• Contact: Silvi Frenkel-Toledo
• Phone: 972545509413
• Email: silvi197[@]bezeqint.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

Inclusion Criteria:

• First stroke

• Age 25-80 years

• Able to understand research instructions

Exclusion Criteria:

• Unstable clinical/metabolic state

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Israel	Loewenstain hospital	Raanana

Sponsors (2)

Lead Sponsor	Collaborator
Nachum Soroker, MD	Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).