Hemiparesis;Poststroke/CVAPhase 1NCT05342688
Contextual Interference, Engagement , and Change in Motor Performance in Stroke
A Phase 1 study testing Task-specific practice of upper extremity functions in people with Hemiparesis;Poststroke/CVA, run by University of Haifa at 1 site in Israel.
Trial summary
The aim of the study is to examine associations between contextual interference (CI), engagement during practice and changes in upper limb motor performance among patients post-stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiparesis;Poststroke/CVA
- What is being tested?
- Task-specific practice of upper extremity functions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2020to Jun 2023
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Five days to 1-year post-stroke
- Score of 11-60 on the Fugl-Meyer Assessment for upper extremity
- The patient receives physical therapy and/or occupational therapy rehabilitation treatment
Who cannot join
- A history of neurological diseases other than stroke or orthopedics conditions that impair upper extremity function
- Pain that prevents active movement of the upper extremity
- Hemodynamic instability
- Cognitive decline and language difficulties that do not allow understanding of instructions and cooperation.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Reut Medical Center
Tel Aviv
Gadi Bartur, PhD
About this study
Official title: Associations Between Contextual Interference, Engagement During Treatment, and Change in Motor Performance Among Patients Posts-stroke
The aim of the study is to examine associations between contextual interference (CI), engagement during practice and changes in upper limb motor performance among patients post-stroke.
Fifty patients over the age of 18, after a stroke, in the sub-acute and early chronic stages who have weakness of the upper extremity and are treated in a rehabilitation center will be recruited.
The study will include participation in five sessions: session 1 for baseline assessment, session 2-4 for practice of upper extremity functions, and session 5 for post intervention assessment. The intervention will include training of three items from the Wolf motor function test in random order (high CI group) or block order (low CI group). Outcomes of engagement will include the brain engagement index, heart rate variability and galvanic skin response. Outcomes of learning will include the pre-post change in performance of the wolf motor function selected items.
Read the detailed description
The aim of the study is to examine associations between contextual interference (CI), engagement during practice, and changes in upper limb motor performance among patients post-stroke.
Fifty patients over the age of 18, after a stroke, in the sub-acute and early chronic stages who are treated in a rehabilitation center inpatient or outpatient clinics, who have hemiparesis (Fugl-Meyer score = 11-60) will be recruited.
Patients with a history of neurological diseases other than stroke or orthopedics conditions that impair upper extremity function, pain that prevents active movement, hemodynamic instability, cognitive decline and language difficulties that do not allow understanding of instructions and cooperation will be excluded.
The study will include participation in five sessions. In the first session, participants will answer a demographic questionnaire and a set of motor (including the Wolf motor function test), perception and cognitive tests will be delivered. Then participants will be assigned to either high or low CI groups. In the next three sessions, participants will practice three items from the Wolf motor functions test. Participants in the high CI group will practice the items in random order and those in the low CI group will practice the selected items in blocked order. Assessment of outcomes during practice will include assessment of brain engagement index by recording EEG (one electrode) and heart rate variability and galvanic skin response. In the fifth session, at the end of the intervention, a reassessment of the wolf motor function performance will be performed.
- Conditions
- Hemiparesis;Poststroke/CVA
- Being tested
- Task-specific practice of upper extremity functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-specific practice of upper extremity functionsBehavioural
The intervention will consist of training of items from the Wolf motor function test.
| Study group | Role | What they receive |
|---|---|---|
| High contextual interference | Experimental | The intervention will involve practicing three items from the Wolf motor function test in random order during three sessions. Each item will be repeated 30 times in total. Receives: Behavioral: Task-specific practice of upper extremity functions |
| Low contextual interference | Active comparator | The intervention will involve practicing three items from the Wolf motor function test in blocked order during three sessions. Each item will be repeated 30 times in total. Receives: Behavioral: Task-specific practice of upper extremity functions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brain Engagement Index
EEG activity in the prefrontal cortex will be measured by MindWave mobile EEG headset.
Measured: Practice session 1 (1-2 days following pre-intervention session), practice session 2 (1-2 days following practice session1), and practice session 3 (1-2 days following practice session1)
Change in time to complete each of three items of the Wolf Motor Function Test (WMFT)
A maximum of 120 seconds is allowed. Any performance that exceeds 120 seconds is assigned 120 seconds.
Measured: Pre-intervention session (first session), post-intervention session (session 5, 5-7 days following the pre-intervention session))
Secondary outcomes (2)
Changes in Heart rate variability
Photoplethysmograph sensor will be placed on the ring finger. Data will be used to extract R-R beat interval, and variability will be measured.
Measured: Practice session 1 (1-2 days following pre-intervention session), practice session 2 (1-2 days following practice session1), and practice session 3 (1-2 days following practice session1)
Changes in Galvanic Skin Response (GSR)
GSR electrodes will be placed on the index and middle fingers, and the signal is reported in micro-Siemens (μS) units.
Measured: Practice session 1 (1-2 days following pre-intervention session), practice session 2 (1-2 days following practice session1), and practice session 3 (1-2 days following practice session1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Jan 2020
- Primary completionJan 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparesis;Poststroke/CVAStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a randomized controlled trial with a pre-post design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Reuth Rehabilitation Hospital
- Responsible party
- Principal investigator, Michal Kafri, PhD, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342688
- Sponsor's protocol ID
- 0012-19-RRH
- Status last verified
- Apr 2022
- First submitted
- 9 Nov 2021
- Last updated
- 25 Apr 2022
- 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 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Contextual Interference, Engagement During Treatment, and Change in Motor Performance Among Patients Posts-stroke
- ClinicalTrials.gov ID
- NCT05342688
- Acronym / sponsor ID
- 0012-19-RRH
- Conditions
- Hemiparesis;Poststroke/CVA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Reuth Rehabilitation Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 25 Apr 2022 (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 aim of the study is to examine associations between contextual interference (CI), engagement during practice and changes in upper limb motor performance among patients post-stroke.
Fifty patients over the age of 18, after a stroke, in the sub-acute and early chronic stages who have weakness of the upper extremity and are treated in a rehabilitation center will be recruited.
The study will include participation in five sessions: session 1 for baseline assessment, session 2-4 for practice of upper extremity functions, and session 5 for post intervention assessment. The intervention will include training of three items from the Wolf motor function test in random order (high CI group) or block order (low CI group). Outcomes of engagement will include the brain engagement index, heart rate variability and galvanic skin response. Outcomes of learning will include the pre-post change in performance of the wolf motor function selected items.
Detailed description
The aim of the study is to examine associations between contextual interference (CI), engagement during practice, and changes in upper limb motor performance among patients post-stroke.
Fifty patients over the age of 18, after a stroke, in the sub-acute and early chronic stages who are treated in a rehabilitation center inpatient or outpatient clinics, who have hemiparesis (Fugl-Meyer score = 11-60) will be recruited.
Patients with a history of neurological diseases other than stroke or orthopedics conditions that impair upper extremity function, pain that prevents active movement, hemodynamic instability, cognitive decline and language difficulties that do not allow understanding of instructions and cooperation will be excluded.
The study will include participation in five sessions. In the first session, participants will answer a demographic questionnaire and a set of motor (including the Wolf motor function test), perception and cognitive tests will be delivered. Then participants will be assigned to either high or low CI groups. In the next three sessions, participants will practice three items from the Wolf motor functions test. Participants in the high CI group will practice the items in random order and those in the low CI group will practice the selected items in blocked order. Assessment of outcomes during practice will include assessment of brain engagement index by recording EEG (one electrode) and heart rate variability and galvanic skin response. In the fifth session, at the end of the intervention, a reassessment of the wolf motor function performance will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be a randomized controlled trial with a pre-post design.
| Arm | Type | Receives |
|---|---|---|
| High contextual interference | Experimental | Behavioral: Task-specific practice of upper extremity functionsThe intervention will involve practicing three items from the Wolf motor function test in random order during three sessions. Each item will be repeated 30 times in total. |
| Low contextual interference | Active comparator | Behavioral: Task-specific practice of upper extremity functionsThe intervention will involve practicing three items from the Wolf motor function test in blocked order during three sessions. Each item will be repeated 30 times in total. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Five days to 1-year post-stroke
- Score of 11-60 on the Fugl-Meyer Assessment for upper extremity
- The patient receives physical therapy and/or occupational therapy rehabilitation treatment
Key exclusion criteria (4 listed)
- A history of neurological diseases other than stroke or orthopedics conditions that impair upper extremity function
- Pain that prevents active movement of the upper extremity
- Hemodynamic instability
- Cognitive decline and language difficulties that do not allow understanding of instructions and cooperation.
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 |
|---|---|---|
| Task-specific practice of upper extremity functionsThe intervention will consist of training of items from the Wolf motor function test. | Behavioural | High contextual interference, Low contextual interference |
Primary outcome
Change in Brain Engagement Index
Time frame: Practice session 1 (1-2 days following pre-intervention session), practice session 2 (1-2 days following practice session1), and practice session 3 (1-2 days following practice session1)
EEG activity in the prefrontal cortex will be measured by MindWave mobile EEG headset.
Change in time to complete each of three items of the Wolf Motor Function Test (WMFT)
Time frame: Pre-intervention session (first session), post-intervention session (session 5, 5-7 days following the pre-intervention session))
A maximum of 120 seconds is allowed. Any performance that exceeds 120 seconds is assigned 120 seconds.
2 secondary outcomes
Changes in Heart rate variability
Time frame: Practice session 1 (1-2 days following pre-intervention session), practice session 2 (1-2 days following practice session1), and practice session 3 (1-2 days following practice session1)
Changes in Galvanic Skin Response (GSR)
Time frame: Practice session 1 (1-2 days following pre-intervention session), practice session 2 (1-2 days following practice session1), and practice session 3 (1-2 days following practice session1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Hemiparesis;Poststroke/CVA
Active, not recruiting
Comparative Effects of CIMT and TOT on Hand Function Recovery in Post Stroke Patients
Poststroke/CVA Hemiparesis
Not yet recruiting
Characterization of Muscle Activity During a Surface EMG-controlled Rehabilitation Game
Cerebral Palsy, Hemiparesis; Poststroke/CVA
Not yet recruiting
Development and Efficacy of a Novel, Cost-Effective Gait Training Device Utilized at Home for Stroke Survivors
Stroke, Neurological Diseases or Conditions
RecruitingPhase 1
Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability
Stroke, Chronic Stroke
Recruiting
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors
Stroke, Stroke Sequelae
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Task-specific practice of upper extremity functions in people with Hemiparesis;Poststroke/CVA, run by University of Haifa 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 4 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: status not confirmed, as of the sponsor's last update on 25 Apr 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Kafri, PhD (972586862261, kafri.michal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brain Engagement Index (time frame: Practice session 1 (1-2 days following pre-intervention session), practice session 2 (1-2 days following practice session1), and practice session 3 (1-2 days following practice session1)). 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 25 Apr 2022.