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Feasibility of Constraint-induced Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke (ITHEMICAL)

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ClinicalTrials.gov Identifier: NCT03754166
Recruitment Status : Terminated (Study non feasible following changes in organisation of service)
First Posted : November 27, 2018
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Stroke Other: Constraint-induced movement therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Modified Constraint-induced Movement Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke
Actual Study Start Date : January 18, 2019
Actual Primary Completion Date : February 12, 2020
Actual Study Completion Date : February 12, 2020

Arm Intervention/treatment
Experimental: Constraint-induced movement therapy

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.

Other: Constraint-induced movement therapy

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.

Other Name: Visual-spatial cueing : top down

No Intervention: Usual care
Usual care of the neurovascular unit. = No constraint, no cueing, and same physiotherapy intervention as experimental arm.



Primary Outcome Measures :
  1. Number of tasks realized per protocol between the two arms [ Time Frame: Day 15 ]
    Variances to a predetermined checklist


Secondary Outcome Measures :
  1. Arm motor function [ Time Frame: Day 0, Day 15 and Month 3 ]
    Action Research Arm Test

  2. Pain evolution [ Time Frame: Day 0, Day 7, Day 15 and Month 3 ]
    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)

  3. Anxiety and Depression evolution [ Time Frame: Day 0, Day 7, Day 15 and Month 3 ]
    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.

  4. Situation of patient after neurovascular unit [ Time Frame: Month 3 ]
    Indication of patient 's situation at the end of the study: either Rehabilitation center, Nursing homes, Home or Other



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754166


Locations
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France
Service de Neurologie, CHU Nantes
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Ambre Komonski CHU Nantes
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03754166    
Other Study ID Numbers: RC18_0288
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases