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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03575481
Other study ID # 0295-15-HMO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 30, 2015
Est. completion date March 29, 2017

Study information

Verified date June 2018
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators compared the activity and fatigue of upper extremity muscles, pain levels, subject satisfaction levels, perceived exertion, and number of repetitions in Task-Specific Training (TST) compared with Robot-Assisted Training (RAT) in individuals post-stroke.


Description:

Twenty sub-acute post stroke subjects received one TST and one RAT. They marked the pain level in their paretic extremity before and after each session. Muscle activity levels and fatigue and number of repetitions were monitored during each session. The subjective assessment questionnaire of treatment and the Borg scale were administered post-session.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 29, 2017
Est. primary completion date March 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- 18 to 85 year old individuals up to three months following stroke

- National Institutes of Health Stroke Scale (NIHSS) score 3-15

- Intact cognitive function

- mild to moderate weakness of the affected hand

- normal or corrected eyesight

Exclusion Criteria:

- neurological, cardio-vascular or orthopedic impairment, unrelated to the stroke, which restricts upper limb function

- a pace-maker

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
The RAT and The TST
The RAT (ReoGo; Motorika Medical, Caesarea, Israel) The TST protocol included the conventional, repetitive, task-oriented training of the affected arm.

Locations

Country Name City State
Israel Hadassah Medical Center Jerusalem

Sponsors (2)

Lead Sponsor Collaborator
Hadassah Medical Organization Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle activity The activity levels of electromyographic signal (in millivolts) will be averaged for the duration of the recording. 30 minutes
Primary Muscle fatigue Fatigue expressed by calculation of the the difference between the median frequency in the first 5 minutes and last five minutes of a 30 minute session 30 minutes
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