StrokeNCT03604081
Effectiveness of Modified Constraint Induced Movement Therapy to Improve Lower Extremity Function in the Acute and Subacute Stroke Patients by Providing 1 Hour of Intense Massed Practice in the Form of Shaping or Task Practice
A study testing CIMT and Conventional Physical Therapy in people with Stroke, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a prospective randomized control trial of patients with unilateral impairment of the lower extremity after stroke. Patients will be randomized to intervention group and control group. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- CIMT and Conventional Physical Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2018to 14 Aug 2020
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55 or older
- new ischemic stroke as revealed by CT scan or MRI of a brain or as per updated definition by American heart and American stroke association (Sacco et al., 2013)
- Manual muscle testing with grad of > 1+ in hip and knee joint musculature
- able to walk atleast 10 feet indoors with or without assistance and assistive device.
- Motivated to participate and some initiation of flexion and extension movement in hip, knee and ankle joints.
- Ability to follow visual/verbal instructions as assessed by a minimum score of 24/30 points on the minimental state examination
- Fairly intact sensation
Who cannot join
- Serious cardiac or pulmonary condition or other medical condition that make it difficult or risky to participate in intensive training
- Severe joint pain or degenerative disease to the musculoskeletal system of the lower extremity
- other neurological disease 4) problems with following instructions.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Effectiveness of Modified Constraint Induced Movement Therapy to Improve Lower Extremity Function in the Acute and Subacute Stroke Patients by Providing 1 Hour of Intense Massed Practice in the Form of Shaping or Task Practice, 7 Times Per Week for 2 Weeks.
This is a prospective randomized control trial of patients with unilateral impairment of the lower extremity after stroke. Patients will be randomized to intervention group and control group. Intervention group will receive one hour of intense massed practice of lower extremity either in the form of shaping or task practice. Control group will receive conventional physical therapy for 1 hour as per current standard of care that follows stroke clinical practice guideline.
- Conditions
- Stroke
- Being tested
- CIMT, Conventional Physical Therapy
- Keywords
- Constraint Induced Movement Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIMTOther
Intervention group will receive one hour of intense massed practice of lower extremity either in the form of shaping or task practice.
Conventional Physical TherapyOther
1 hour as per current standard of care that follows stroke clinical practice guideline.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | One hour of intense massed practice of lower extremity either in the form of shaping or task practice Receives: Other: CIMT |
| Control Group | Placebo comparator | Conventional physical therapy for 1 hour as per current standard of care that follows stroke clinical practice guideline. Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycle time as measured by GAITRite.
GAITrite is considered a gold standard for gait analysis. It consists of a mat with the sensors which are pressure sensitive and when patient ambulates on the mat the system measures parameters like step length, stride length, cycle time and velocity.
Measured: 2 Weeks
step length as measured by GAITRite.
GAITrite is considered a gold standard for gait analysis. It consists of a mat with the sensors which are pressure sensitive and when patient ambulates on the mat the system measures parameters like step length, stride length, cycle time and velocity.
Measured: 2 Weeks
Stride length as measured by GAITRite.
GAITrite is considered a gold standard for gait analysis. It consists of a mat with the sensors which are pressure sensitive and when patient ambulates on the mat the system measures parameters like step length, stride length, cycle time and velocity.
Measured: 2 Weeks
velocity as measured by GAITRite
GAITrite is considered a gold standard for gait analysis. It consists of a mat with the sensors which are pressure sensitive and when patient ambulates on the mat the system measures parameters like step length, stride length, cycle time and velocity.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start11 Jun 2018
- Primary completion14 Aug 2020
- Study completion14 Aug 2020
Why it stopped: PI has encountered recruitment challenges.
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.
- More trials run by NYU Langone HealthThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nada Abou-Fayssal, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604081
- Sponsor's protocol ID
- 17-00773
- Status last verified
- Aug 2020
- First submitted
- 18 Jul 2018
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Modified Constraint Induced Movement Therapy to Improve Lower Extremity Function in the Acute and Subacute Stroke Patients by Providing 1 Hour of Intense Massed Practice in the Form of Shaping or Task Practice, 7 Times Per Week for 2 Weeks.
- ClinicalTrials.gov ID
- NCT03604081
- Acronym / sponsor ID
- 17-00773
- Conditions
- Stroke
- Keywords
- Constraint Induced Movement Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI has encountered recruitment challenges.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 14 Aug 2020 (actual)
- First posted
- 27 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.
This is a prospective randomized control trial of patients with unilateral impairment of the lower extremity after stroke. Patients will be randomized to intervention group and control group. Intervention group will receive one hour of intense massed practice of lower extremity either in the form of shaping or task practice. Control group will receive conventional physical therapy for 1 hour as per current standard of care that follows stroke clinical practice guideline.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: CIMTOne hour of intense massed practice of lower extremity either in the form of shaping or task practice |
| Control Group | Placebo comparator | Other: Conventional Physical TherapyConventional physical therapy for 1 hour as per current standard of care that follows stroke clinical practice guideline. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 55 or older
- new ischemic stroke as revealed by CT scan or MRI of a brain or as per updated definition by American heart and American stroke association (Sacco et al., 2013)
- Manual muscle testing with grad of > 1+ in hip and knee joint musculature
- able to walk atleast 10 feet indoors with or without assistance and assistive device.
- Motivated to participate and some initiation of flexion and extension movement in hip, knee and ankle joints.
Key exclusion criteria (3 listed)
- Serious cardiac or pulmonary condition or other medical condition that make it difficult or risky to participate in intensive training
- Severe joint pain or degenerative disease to the musculoskeletal system of the lower extremity
- other neurological disease 4) problems with following instructions.
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 |
|---|---|---|
| CIMTIntervention group will receive one hour of intense massed practice of lower extremity either in the form of shaping or task practice. | Other | Intervention Group |
| Conventional Physical Therapy1 hour as per current standard of care that follows stroke clinical practice guideline. | Other | Control Group |
Primary outcome
Cycle time as measured by GAITRite.
Time frame: 2 Weeks
GAITrite is considered a gold standard for gait analysis. It consists of a mat with the sensors which are pressure sensitive and when patient ambulates on the mat the system measures parameters like step length, stride length, cycle time and velocity.
step length as measured by GAITRite.
Time frame: 2 Weeks
GAITrite is considered a gold standard for gait analysis. It consists of a mat with the sensors which are pressure sensitive and when patient ambulates on the mat the system measures parameters like step length, stride length, cycle time and velocity.
Stride length as measured by GAITRite.
Time frame: 2 Weeks
GAITrite is considered a gold standard for gait analysis. It consists of a mat with the sensors which are pressure sensitive and when patient ambulates on the mat the system measures parameters like step length, stride length, cycle time and velocity.
velocity as measured by GAITRite
Time frame: 2 Weeks
GAITrite is considered a gold standard for gait analysis. It consists of a mat with the sensors which are pressure sensitive and when patient ambulates on the mat the system measures parameters like step length, stride length, cycle time and velocity.
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 2 Sep 2020.
Related trials for Stroke
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Ischemic Stroke
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Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
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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.
Nada Abou-Fayssal, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CIMT and Conventional Physical Therapy in people with Stroke, run by NYU Langone Health at 1 site in United States.
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 7 inclusion and 3 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 2 Sep 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Cycle time as measured by GAITRite. (time frame: 2 Weeks). The study lists 4 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 Sep 2020.