Stroke PatientsNCT01696864
Remote Rehabilitation Via the Internet in Patients After a Stroke - Physical Rehabilitation Using Biofeedback Systems to Improve Upper Extremity Function
A study testing Hand tutor rehabilitation device and Arm tutor rehabilitation device in people with Stroke Patients, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The objective of this study is to examine monitored rehabilitation therapy over the internet to improve upper limb function for stroke patients. Home rehabilitation for stroke patients will avoid the burden of arrival to the health facilities, making it easier on them and improve their quality of life and the lives of… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke Patients
- What is being tested?
- Hand tutor rehabilitation device and Arm tutor rehabilitation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2016to Dec 2016
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke patients who had at least eight conventional rehabilitation treatments lasted at least until a month before the start of the experiment,
- not affected cognitively (to be determined by the score on the mini mental exam greater than 23).
- patients have daily access to a computer and the Internet, and use a personal caregiver or family member can supervise the use of the system.
Who cannot join
- Global or sensory aphasia, unilateral spatial neglect, apraxia and other acute neurological or orthopedic conditions.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to examine monitored rehabilitation therapy over the internet to improve upper limb function for stroke patients. Home rehabilitation for stroke patients will avoid the burden of arrival to the health facilities, making it easier on them and improve their quality of life and the lives of their caregivers. To achieve this goal the investigators will examine the effectiveness and feasibility of home rehabilitation system of upper limb, consisting of ergonomic accessories (hand and arm tutors).
The quantitative indices will be based on the quantitative clinical measures that are used in regular evaluations of stroke patients and function and range of motion indices as received from the system.
- Conditions
- Stroke Patients
- Being tested
- Hand tutor rehabilitation device, Arm tutor rehabilitation device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand tutor rehabilitation deviceDevice
A rehabilitation device for the hand
Arm tutor rehabilitation deviceDevice
A rehabilitation device for the arm
| Study group | Role | What they receive |
|---|---|---|
| stroke patients - hand | Experimental | stroke patients with the ability to move their hand Receives: Device: Hand tutor rehabilitation device |
| stroke patient - arm | Experimental | stroke patients with the ability to move their arms Receives: Device: Arm tutor rehabilitation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment upper extremity part (FMA)
The FMA assesses the motor impairment of the upper extremity after stroke. Each movement is graded on a 3-point scale, and the total score for the upper extremity ranges from 0-60 points where a higher score represents more active movements. An additional part assesses the coordination of the affected upper extremity and the score ranges between 0-6 where a higher score represents poorer coordination ability. This test is one of the most commonly used instruments in rehabilitation and its validity and reliability have been well established
Measured: 10 minutes
Arm and Hand Activity Inventory (CAHAI)
The test assesses the functional ability of the affected arm and hand of people with stroke. The abbreviated version includes 7 functional activities (e.g. open a jar of coffee) that require bilateral use of the upper extremities as well various types of grip. The score range between1 and 7
Measured: 10 minutes
Motor Activity Log (MAL)
The MAL consist of a semi structured interview for the patient to assess the use of the paretic arm and hand during daily activities. Two scores on a scale of 1 -5, are given for each activity;for the amount of use (AOU) and for the quality of movement (QOM). Usability of the system i.e. ease of use of the system
Measured: 10 minutes
System Usability Scale (SUS)
This questionnaire includes 10 items rated on a 5 points scale, which provide a global view of subjective assessment of a system's usability. The item scores were calculated to give an overall score ranging from 10 to 100 points. The SUS has been shown to be a robust and reliable evaluation tool
Measured: 10 minutes
Box& Block Test of Manual Dexterity
This is a valid and reliable test which is used to assess hand dexterity. In addition it is used to assess endurance of the upper extremity. The subject is asked to transfer cubes, above a partition, from one side of a box to the other for one minute with both hands. The score is the number of cubes that were transferred. In addition: Range of motion of fingers, wrist elbow and shoulder as measured by the devices
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke PatientsStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gabi Zeilig, Dr., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696864
- Sponsor's protocol ID
- SHEBA-12-9471-GZ-CTIL
- Status last verified
- Jan 2017
- First submitted
- 10 Sep 2012
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Rehabilitation Via the Internet in Patients After a Stroke - Physical Rehabilitation Using Biofeedback Systems to Improve Upper Extremity Function
- ClinicalTrials.gov ID
- NCT01696864
- Acronym / sponsor ID
- SHEBA-12-9471-GZ-CTIL
- Conditions
- Stroke Patients
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Oct 2012 (estimated)
- 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 objective of this study is to examine monitored rehabilitation therapy over the internet to improve upper limb function for stroke patients. Home rehabilitation for stroke patients will avoid the burden of arrival to the health facilities, making it easier on them and improve their quality of life and the lives of their caregivers. To achieve this goal the investigators will examine the effectiveness and feasibility of home rehabilitation system of upper limb, consisting of ergonomic accessories (hand and arm tutors).
The quantitative indices will be based on the quantitative clinical measures that are used in regular evaluations of stroke patients and function and range of motion indices as received from the system.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stroke patients - hand | Experimental | Device: Hand tutor rehabilitation devicestroke patients with the ability to move their hand |
| stroke patient - arm | Experimental | Device: Arm tutor rehabilitation devicestroke patients with the ability to move their arms |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stroke patients who had at least eight conventional rehabilitation treatments lasted at least until a month before the start of the experiment,
- not affected cognitively (to be determined by the score on the mini mental exam greater than 23).
- patients have daily access to a computer and the Internet, and use a personal caregiver or family member can supervise the use of the system.
Key exclusion criteria (1 listed)
- Global or sensory aphasia, unilateral spatial neglect, apraxia and other acute neurological or orthopedic conditions.
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 |
|---|---|---|
| Hand tutor rehabilitation deviceA rehabilitation device for the hand | Device | stroke patients - hand |
| Arm tutor rehabilitation deviceA rehabilitation device for the arm | Device | stroke patient - arm |
Primary outcome
Fugl-Meyer Assessment upper extremity part (FMA)
Time frame: 10 minutes
The FMA assesses the motor impairment of the upper extremity after stroke. Each movement is graded on a 3-point scale, and the total score for the upper extremity ranges from 0-60 points where a higher score represents more active movements. An additional part assesses the coordination of the affected upper extremity and the score ranges between 0-6 where a higher score represents poorer coordination ability. This test is one of the most commonly used instruments in rehabilitation and its validity and reliability have been well established
Arm and Hand Activity Inventory (CAHAI)
Time frame: 10 minutes
The test assesses the functional ability of the affected arm and hand of people with stroke. The abbreviated version includes 7 functional activities (e.g. open a jar of coffee) that require bilateral use of the upper extremities as well various types of grip. The score range between1 and 7
Motor Activity Log (MAL)
Time frame: 10 minutes
The MAL consist of a semi structured interview for the patient to assess the use of the paretic arm and hand during daily activities. Two scores on a scale of 1 -5, are given for each activity;for the amount of use (AOU) and for the quality of movement (QOM). Usability of the system i.e. ease of use of the system
System Usability Scale (SUS)
Time frame: 10 minutes
This questionnaire includes 10 items rated on a 5 points scale, which provide a global view of subjective assessment of a system's usability. The item scores were calculated to give an overall score ranging from 10 to 100 points. The SUS has been shown to be a robust and reliable evaluation tool
Box& Block Test of Manual Dexterity
Time frame: 10 minutes
This is a valid and reliable test which is used to assess hand dexterity. In addition it is used to assess endurance of the upper extremity. The subject is asked to transfer cubes, above a partition, from one side of a box to the other for one minute with both hands. The score is the number of cubes that were transferred. In addition: Range of motion of fingers, wrist elbow and shoulder as measured by the devices
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
Related trials for Stroke Patients
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Medico-Economic Evaluation of MRI Versus CT as Diagnostic Imaging Strategies in Patients With Suspected Ischemic Stroke: the MAGRITTE Study.
Stroke
Recruiting
Cervical tsDCS on Stroke Patients
Functional Recovery, Motor Rehabilitation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
Not yet recruitingPhase 2/3
A Phase II/III Clinical Study of SIM0811 in the Treatment of Acute Ischemic Stroke
Acute Ischemic Stroke AIS
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.
Gabi Zeilig, Dr. principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand tutor rehabilitation device and Arm tutor rehabilitation device in people with Stroke Patients, run by Sheba Medical Center 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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 4 Jan 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Fugl-Meyer Assessment upper extremity part (FMA) (time frame: 10 minutes). The study lists 5 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 4 Jan 2017.