Clinical trial NCT03146559: Using EMG of the Healthy Hand to Control TENS of the Affected Hand in Hemiparetic Patients
Official title: Using EMG of the Healthy Hand to Control TENS of the Affected Hand in Hemiparetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Cross education
EMG
Lead sponsor: Loewenstein Hospital
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2017-05-10
Enrollment: 14
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Unstable clinical/metabolic state

Primary outcomes:
measure: Change in active range of motion of wrist dorsi flexion and fingers extension
timeFrame: Baseline, after 3 weeks of intervention and one month after the end of the intervention (follow up).
Secondary outcomes:
measure: Change in Fugl-Meyer Assessment
timeFrame: Baseline, after 3 weeks of intervention and one month after the end of the intervention (follow up).
measure: Change in Box and Blocks test
timeFrame: Baseline, after 3 weeks of intervention and one month after the end of the intervention (follow up).
measure: Change in Jebsen Taylor Hand Function Test
timeFrame: Baseline, after 3 weeks of intervention and one month after the end of the intervention (follow up).
Other outcomes:
Locations:
city: Raanana
country: Israel
facility: Loewenstain hospital
Study officials:
affiliation: Loewenstein Hospital
name: Sivi Frenkel-Toledo, PhD
role: STUDY_DIRECTOR
References: