Feasibility of Constraint-induced Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke (ITHEMICAL)
Primary Purpose
Acute Stroke
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Constraint-induced movement therapy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Stroke
Eligibility Criteria
Inclusion Criteria:
- 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°
- Age ≥ 18 years old
- Patient agreement to join the study
- Patient covered by french social security
Exclusion Criteria:
- 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
Sites / Locations
- Service de Neurologie, CHU Nantes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Constraint-induced movement therapy
Usual care
Arm Description
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.
Usual care of the neurovascular unit. = No constraint, no cueing, and same physiotherapy intervention as experimental arm.
Outcomes
Primary Outcome Measures
Number of tasks realized per protocol between the two arms
Variances to a predetermined checklist
Secondary Outcome Measures
Arm motor function
Action Research Arm Test
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)
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.
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
Full Information
NCT ID
NCT03754166
First Posted
November 20, 2018
Last Updated
December 14, 2020
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03754166
Brief Title
Feasibility of Constraint-induced Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke
Acronym
ITHEMICAL
Official Title
Feasibility of Modified Constraint-induced Movement Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Study non feasible following changes in organisation of service
Study Start Date
January 18, 2019 (Actual)
Primary Completion Date
February 12, 2020 (Actual)
Study Completion Date
February 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Constraint-induced movement therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care of the neurovascular unit. = No constraint, no cueing, and same physiotherapy intervention as experimental arm.
Intervention Type
Other
Intervention Name(s)
Constraint-induced movement therapy
Other Intervention Name(s)
Visual-spatial cueing : top down
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of tasks realized per protocol between the two arms
Description
Variances to a predetermined checklist
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Arm motor function
Description
Action Research Arm Test
Time Frame
Day 0, Day 15 and Month 3
Title
Pain evolution
Description
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)
Time Frame
Day 0, Day 7, Day 15 and Month 3
Title
Anxiety and Depression evolution
Description
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.
Time Frame
Day 0, Day 7, Day 15 and Month 3
Title
Situation of patient after neurovascular unit
Description
Indication of patient 's situation at the end of the study: either Rehabilitation center, Nursing homes, Home or Other
Time Frame
Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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°
Age ≥ 18 years old
Patient agreement to join the study
Patient covered by french social security
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ambre Komonski
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neurologie, CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
12. IPD Sharing Statement
Learn more about this trial
Feasibility of Constraint-induced Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke
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