StrokeNCT02345525
Constraint-Induced Movement Therapy in Chronic Stroke Patients
A study testing mCIMT and hCIMT in people with Stroke, run by University Hospital of Ferrara at 1 site in Italy.
Trial summary
The aim of this study is to evaluate the feasibility of a Home-based Constraint-Induced Movement Therapy (hCIMT) compared to a Modified Constraint-Induced Movement Therapy (mCIMT) delivered in a outpatient setting on upper limb motor recovery in stroke survivors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- mCIMT and hCIMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2014to Aug 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years and < 80 years
- diagnosis of first ischemic stroke
- stroke onset > 6 months prior to study enrollment
- upper extremity hemiparesis with impairment of hand and/or arm:
- active wrist extension ≥20º
- active metacarpophalangeal- and interphalangeal-joints extension ≥ 10°
- muscle tone assessed by the Modified Ashworth Scale (MAS) ≤ 2
- pain assessed by the Visual Analogue Scale (VAS) <4
Who cannot join
- anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test
- impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
- contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
- neurological or psychiatric pathology
- severe cardio-pulmonary, renal, hepatic diseases
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility of a Home-based Constraint-Induced Movement Therapy Program in Chronic Stroke Survivors.
The aim of this study is to evaluate the feasibility of a Home-based Constraint-Induced Movement Therapy (hCIMT) compared to a Modified Constraint-Induced Movement Therapy (mCIMT) delivered in a outpatient setting on upper limb motor recovery in stroke survivors.
Read the detailed description
Home-based Constraint Induced Modified Therapy (hCIMT) consist of 2 hours intensive upper limb practice with shaping techniques + 2 hours ADLs supervised by a caregiver. Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily.
Modified Constraint Induced Modified Therapy (mCIMT) consist of 2 hours intensive upper limb practice with shaping techniques supervised by an experienced physiotherapist + 2 hours ADLs at home (supervised by a caregiver) Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily.
- Conditions
- Stroke
- Being tested
- mCIMT, hCIMT
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mCIMTBehavioural
This intervention is based on 3 main aspects:
- intensive training of functional tasks with the affected arm (massed practice)
- constraint of the un-affected hand through a mitt
- shaping techniques designed to transfer gains to the real world activities
The 2 hours massed practice will be performed in a outpatient clinic with a supervision of PT.
hCIMTBehavioural
This intervention is based on 3 main aspects:
- intensive training of functional tasks with the affected arm (massed practice)
- constraint of the un-affected hand through a mitt
- shaping techniques designed to transfer gains to the real world activities
In this group, a comprehensive set of the material necessary to perform the training at home and a booklet containing an explanation of the exercises that can be done will be provided to subjects.
In addition, 2 hospital visits will be scheduled to instruct subjects and caregivers on the training and to update activities (1 visit at the beginning + 1 visit after 1 week).
| Study group | Role | What they receive |
|---|---|---|
| mCIMT | Active comparator | 2 hours intensive upper limb practice with shaping techniques supervised by an experienced physiotherapist + 2 hours ADLs at home (supervised by a caregiver) Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily. Receives: Behavioral: mCIMT |
| hCIMT | Experimental | 2 hours intensive upper limb practice with shaping techniques + 2 hours ADLs supervised by a caregiver.
Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily. Receives: Behavioral: hCIMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.
Measured: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Secondary outcomes (6)
Wolf Motor Function Test (WMFT)
Quantitative measure of upper extremity motor ability through timed and functional tasks.
Measured: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Nine Hole Peg Test (NHPT
Measures finger dexterity
Measured: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Motor Activity Log (MAL)
Assessment of the change in real-world arm use in activities of daily living. Subjects are asked to score the quality of movement as well as amount of use of the affected arm in a number of common daily activities.
Measured: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Stroke Impact Scale 3.0 (SIS 3.0)
Self-assessment questionnaire assesses health status following stroke
Measured: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Motor cortex excitability (single pulse and paired pulse TMS)
Single-Pulse TMS will be used to study cortical-spinal tract excitability in primary motor cortex (M1).
Paired-pulse TMS Paired-Pulse TMS will be used to study intracortical excitability.
Measured: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
NIRS (Near Infrared Spectroscopy) NIRS measurements will be performed during 6 cycles of 15s hand reaching and grasping and 45s resting while sitting on a chair.
For the NIRS it will use an 32-channel NIRS imaging equipment which consist of 16 pairs of emitting and detecting optical fibers attached to a custom-made head cap placed on primary motor cortex.
NIRS measurements will be performed during 6 cycles of 15s hand reaching and grasping and 45s resting while sitting on a chair.
Measured: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionMay 2017
- Study completionAug 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sofia Straudi, MD, Principal investigator, Ospedale San Giorgio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345525
- Sponsor's protocol ID
- Studio CIMT
- Status last verified
- Dec 2017
- First submitted
- 19 Jan 2015
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of a Home-based Constraint-Induced Movement Therapy Program in Chronic Stroke Survivors.
- ClinicalTrials.gov ID
- NCT02345525
- Acronym / sponsor ID
- Studio CIMT
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 26 Jan 2015 (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 aim of this study is to evaluate the feasibility of a Home-based Constraint-Induced Movement Therapy (hCIMT) compared to a Modified Constraint-Induced Movement Therapy (mCIMT) delivered in a outpatient setting on upper limb motor recovery in stroke survivors.
Detailed description
Home-based Constraint Induced Modified Therapy (hCIMT) consist of 2 hours intensive upper limb practice with shaping techniques + 2 hours ADLs supervised by a caregiver. Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily.
Modified Constraint Induced Modified Therapy (mCIMT) consist of 2 hours intensive upper limb practice with shaping techniques supervised by an experienced physiotherapist + 2 hours ADLs at home (supervised by a caregiver) Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mCIMT | Active comparator | Behavioral: mCIMT2 hours intensive upper limb practice with shaping techniques supervised by an experienced physiotherapist + 2 hours ADLs at home (supervised by a caregiver) Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily. |
| hCIMT | Experimental | Behavioral: hCIMT2 hours intensive upper limb practice with shaping techniques + 2 hours ADLs supervised by a caregiver. Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age > 18 years and < 80 years
- diagnosis of first ischemic stroke
- stroke onset > 6 months prior to study enrollment
- upper extremity hemiparesis with impairment of hand and/or arm:
- active wrist extension ≥20º
Key exclusion criteria (6 listed)
- anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test
- impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
- contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
- neurological or psychiatric pathology
- severe cardio-pulmonary, renal, hepatic diseases
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 |
|---|---|---|
| mCIMTThis intervention is based on 3 main aspects: 1. intensive training of functional tasks with the affected arm (massed practice) 2. constraint of the un-affected hand through a mitt 3. shaping techniques designed to transfer gains to the real world activities The 2 hours massed practice will be performed in a outpatient clinic with a supervision of PT. | Behavioural | mCIMT |
| hCIMTThis intervention is based on 3 main aspects: 1. intensive training of functional tasks with the affected arm (massed practice) 2. constraint of the un-affected hand through a mitt 3. shaping techniques designed to transfer gains to the real world activities In this group, a comprehensive set of the material necessary to perform the training at home and a booklet containing an explanation of the exercises that can be done will be provided to subjects. In addition, 2 hospital visits will be scheduled to instruct subjects and caregivers on the training and to update activities (1 visit at the beginning + 1 visit after 1 week). | Behavioural | hCIMT |
Primary outcome
Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)
Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.
6 secondary outcomes
Wolf Motor Function Test (WMFT)
Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Nine Hole Peg Test (NHPT
Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Motor Activity Log (MAL)
Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Stroke Impact Scale 3.0 (SIS 3.0)
Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Motor cortex excitability (single pulse and paired pulse TMS)
Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
NIRS (Near Infrared Spectroscopy) NIRS measurements will be performed during 6 cycles of 15s hand reaching and grasping and 45s resting while sitting on a chair.
Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
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 20 Dec 2017.
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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.
Sofia Straudi, MD principal investigator
Ospedale San Giorgio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mCIMT and hCIMT in people with Stroke, run by University Hospital of Ferrara at 1 site in Italy.
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 8 inclusion and 6 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 20 Dec 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 Italy. 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?
Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE) (time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up). 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 20 Dec 2017.