Acute StrokeITHEMICALNCT03754166
Feasibility of Constraint-induced Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke
A study testing Constraint-induced movement therapy in people with Acute Stroke, run by Nantes University Hospital at 1 site in France.
Trial summary
The aim of this study is to test the feasibility of a constraint intervention combined with visual-spatial cueing strategy in patients with acute stroke to improve their daily life activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Constraint-induced movement therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2019to 12 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patient in neurovascular unit for stroke
- Time since stroke between 2 and 4 days
- Movement capacity of the upper arm (against gravity) :
- Ability to extend actively the metacarpophalangeal and interphalangeal joints at least 10°, and the wrist 20°
- Ability to bend actively the elbow at least 45°
- Ability to bend and abduct actively the shoulder at least ≥ 45°
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- Age ≥ 18 years old
- Patient agreement to join the study
- Patient covered by french social security
Who cannot join
- Excessive spasticity : score > 2 on the modified Ashworth scale
- Excessive pain in the affected arm : score ≥ 4 on the visual analogue scale
- Joint limitation on the affected arm
- Patient under guardianship or curatorship
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Modified Constraint-induced Movement Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke
The aim of this study is to test the feasibility of a constraint intervention combined with visual-spatial cueing strategy in patients with acute stroke to improve their daily life activities.
Read the detailed description
As part of treatment in acute stroke (from D0 to D14), the investigators were able to observe that despite motor recovery during physiotherapy sessions, it remained difficult for some patients to use their affected arm (AA) during activities of daily life (ADL). This mechanism of "learned non-use" would be due to a cognitive process decreasing the use of the AA and could partly explain that 75% of patients maintain an upper limb deficit at 3-6 month post-stroke.
In order to combat this phenomenon, a bottom up method (sensorimotor action on the deficit) of constraint-induced movement therapy (CIMT) has been developed and consists in immobilizing the unaffected arm to force the use of the AA.
This technique has proved its effectiveness in the chronic phase and has also recently been proven to improve motor performance in the acute phase. Transposing progress on ADL, however, remains difficult because CIMT does not contain adequate behavioral strategies.
To help the patient mobilize these strategies, coupling of CIMT with a top-down method (conscious action on motor skills) has been successfully tested as an intervention of an occupational therapist with the patient at least 1h / day. This intervention remains not compatible with the investigators care organization because the caregiver can not spend that amount of time with each patient.
Investigators therefore propose to associate CIMT with another top down technique: visual-spatial cueing (use of panels and/or visual messages to encourage the conscious use of the AA) and investigators want to evaluate the effectiveness of this treatment on learning transfer to ADL.
The objective of our study will be to test the feasibility of setting up such an intervention.
- Conditions
- Acute Stroke
- Being tested
- 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.
Constraint-induced movement therapyOther
Also called Visual-spatial cueing : top down
Patient's unaffected arm is restrained, by a glove including thumb, during activities of daily life (bathing, grooming, dressing and feeding = approx. 4h/day).
Visual spatial cueing is displayed in the bedroom and the bathroom.
| Study group | Role | What they receive |
|---|---|---|
| Constraint-induced movement therapy | Experimental | Patient's unaffected arm is restrained, by a glove including thumb, during activities of daily life (bathing, grooming, dressing and feeding = approx. 4h/day).
Visual spatial cueing is displayed in the bedroom and the bathroom. Receives: Other: Constraint-induced movement therapy |
| Usual care | No intervention | Usual care of the neurovascular unit. = No constraint, no cueing, and same physiotherapy intervention as experimental arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of tasks realized per protocol between the two arms
Variances to a predetermined checklist
Measured: Day 15
Secondary outcomes (4)
Arm motor function
Action Research Arm Test
Measured: Day 0, Day 15 and Month 3
Pain evolution
Use of Visual analogue scale to determine the degree of pain on a scale from 0 to 10 (0: meaning no pain, 10 being maximal tolerable pain)
Measured: Day 0, Day 7, Day 15 and Month 3
Anxiety and Depression evolution
Use of Hospital Anxiety and Depression Scale. This scale has 14 items in total, 7 items for Anxiety and 7 for Depression. Each item is rated from 0 to 3. score of 0 meaning normal, score 3 meaning abnormal.
Measured: Day 0, Day 7, Day 15 and Month 3
Situation of patient after neurovascular unit
Indication of patient 's situation at the end of the study: either Rehabilitation center, Nursing homes, Home or Other
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start18 Jan 2019
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Why it stopped: Study non feasible following changes in organisation of service
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ambre Komonski, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754166
- Sponsor's protocol ID
- RC18_0288
- Acronym
- ITHEMICAL
- Status last verified
- Dec 2020
- First submitted
- 20 Nov 2018
- Last updated
- 16 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Modified Constraint-induced Movement Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke
- ClinicalTrials.gov ID
- NCT03754166
- Acronym / sponsor ID
- ITHEMICAL / RC18_0288
- Conditions
- Acute Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study non feasible following changes in organisation of service
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 27 Nov 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 aim of this study is to test the feasibility of a constraint intervention combined with visual-spatial cueing strategy in patients with acute stroke to improve their daily life activities.
Detailed description
As part of treatment in acute stroke (from D0 to D14), the investigators were able to observe that despite motor recovery during physiotherapy sessions, it remained difficult for some patients to use their affected arm (AA) during activities of daily life (ADL). This mechanism of "learned non-use" would be due to a cognitive process decreasing the use of the AA and could partly explain that 75% of patients maintain an upper limb deficit at 3-6 month post-stroke.
In order to combat this phenomenon, a bottom up method (sensorimotor action on the deficit) of constraint-induced movement therapy (CIMT) has been developed and consists in immobilizing the unaffected arm to force the use of the AA.
This technique has proved its effectiveness in the chronic phase and has also recently been proven to improve motor performance in the acute phase. Transposing progress on ADL, however, remains difficult because CIMT does not contain adequate behavioral strategies.
To help the patient mobilize these strategies, coupling of CIMT with a top-down method (conscious action on motor skills) has been successfully tested as an intervention of an occupational therapist with the patient at least 1h / day. This intervention remains not compatible with the investigators care organization because the caregiver can not spend that amount of time with each patient.
Investigators therefore propose to associate CIMT with another top down technique: visual-spatial cueing (use of panels and/or visual messages to encourage the conscious use of the AA) and investigators want to evaluate the effectiveness of this treatment on learning transfer to ADL.
The objective of our study will be to test the feasibility of setting up such an intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constraint-induced movement therapy | Experimental | Other: Constraint-induced movement therapyPatient's unaffected arm is restrained, by a glove including thumb, during activities of daily life (bathing, grooming, dressing and feeding = approx. 4h/day). Visual spatial cueing is displayed in the bedroom and the bathroom. |
| Usual care | No intervention | –Usual care of the neurovascular unit. = No constraint, no cueing, and same physiotherapy intervention as experimental arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Hospitalized patient in neurovascular unit for stroke
- Time since stroke between 2 and 4 days
- Movement capacity of the upper arm (against gravity) :
- Ability to extend actively the metacarpophalangeal and interphalangeal joints at least 10°, and the wrist 20°
- Ability to bend actively the elbow at least 45°
Key exclusion criteria (5 listed)
- Excessive spasticity : score > 2 on the modified Ashworth scale
- Excessive pain in the affected arm : score ≥ 4 on the visual analogue scale
- Joint limitation on the affected arm
- Patient under guardianship or curatorship
- Pregnant or breastfeeding woman
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 |
|---|---|---|
| Constraint-induced movement therapyAlso: Visual-spatial cueing : top downPatient's unaffected arm is restrained, by a glove including thumb, during activities of daily life (bathing, grooming, dressing and feeding = approx. 4h/day). Visual spatial cueing is displayed in the bedroom and the bathroom. | Other | Constraint-induced movement therapy |
Primary outcome
Number of tasks realized per protocol between the two arms
Time frame: Day 15
Variances to a predetermined checklist
4 secondary outcomes
Arm motor function
Time frame: Day 0, Day 15 and Month 3
Pain evolution
Time frame: Day 0, Day 7, Day 15 and Month 3
Anxiety and Depression evolution
Time frame: Day 0, Day 7, Day 15 and Month 3
Situation of patient after neurovascular unit
Time frame: Month 3
Results and safety
The study was stopped early (reason given: Study non feasible following changes in organisation of service). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
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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.
Ambre Komonski principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint-induced movement therapy in people with Acute Stroke, run by Nantes University Hospital at 1 site in France.
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 9 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Dec 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 France. 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 stopped early (reason given: Study non feasible following changes in organisation of service). Results are not available in the source record.
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?
Number of tasks realized per protocol between the two arms (time frame: Day 15). 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 16 Dec 2020.