Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03146559
Enrollment
14
Registered
2017-05-10
Start date
2017-05-25
Completion date
2018-05-31
Last updated
2017-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Cross education, EMG

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.

Interventions

DEVICEEMG 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.

DEVICETENS only

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

Sponsors

Tel Aviv University
CollaboratorOTHER
Nachum Soroker, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Unstable clinical/metabolic state

Design outcomes

Primary

MeasureTime frameDescription
Change in active range of motion of wrist dorsi flexion and fingers extensionBaseline, 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

MeasureTime frameDescription
Change in Fugl-Meyer AssessmentBaseline, 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 testBaseline, 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 TestBaseline, 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.

Countries

Israel

Contacts

Primary ContactSilvi Frenkel-Toledo
silvi197@bezeqint.net972545509413
Backup ContactNachum Soroker, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026