StrokeNCT03575481
Muscle Activity of the Upper Limb Between Task-Specific and Robot Assisted Training Among Individuals Post Stroke
An observational study of Stroke, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- The RAT and The TST
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Sep 2015to 29 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stroke survivors
Who may be able to join
- 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
Who cannot join
- neurological, cardio-vascular or orthopedic impairment, unrelated to the stroke, which restricts upper limb function
- a pace-maker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences in Muscle Activity and Fatigue of the Upper Limb Between Task-Specific Training and Robot Assisted Training Among Individuals Post Stroke
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.
Read the detailed 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.
- Conditions
- Stroke
- Being tested
- The RAT and The TST
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The RAT and The TSTDiagnostic test
The RAT (ReoGo; Motorika Medical, Caesarea, Israel) The TST protocol included the conventional, repetitive, task-oriented training of the affected arm.
| Study group | Role | What they receive |
|---|---|---|
| Post stroke patients | Not described Receives: Diagnostic Test: The RAT and The TST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activity
The activity levels of electromyographic signal (in millivolts) will be averaged for the duration of the recording.
Measured: 30 minutes
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
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start30 Sep 2015
- Primary completion1 Mar 2017
- Study completion29 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575481
- Sponsor's protocol ID
- 0295-15-HMO
- Status last verified
- Jun 2018
- First submitted
- 17 Jun 2018
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Muscle Activity and Fatigue of the Upper Limb Between Task-Specific Training and Robot Assisted Training Among Individuals Post Stroke
- ClinicalTrials.gov ID
- NCT03575481
- Acronym / sponsor ID
- 0295-15-HMO
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post stroke patients | – | Diagnostic Test: The RAT and The TST |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stroke survivors
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- neurological, cardio-vascular or orthopedic impairment, unrelated to the stroke, which restricts upper limb function
- a pace-maker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The RAT and The TSTThe RAT (ReoGo; Motorika Medical, Caesarea, Israel) The TST protocol included the conventional, repetitive, task-oriented training of the affected arm. | Diagnostic test | Post stroke patients |
Primary outcome
Muscle activity
Time frame: 30 minutes
The activity levels of electromyographic signal (in millivolts) will be averaged for the duration of the recording.
Muscle fatigue
Time frame: 30 minutes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle activity (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.