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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Stroke
• Intervention / Treatment: Other: Constraint-induced movement therapy

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Service de Neurologie, CHU Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of tasks realized per protocol between the two arms	Variances to a predetermined checklist	Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm motor function	Action Research Arm Test	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)	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.	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	Month 3

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Ambre Komonski, CHU Nantes

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2019
• Primary Completion (Actual): February 12, 2020
• Study Completion (Actual): February 12, 2020

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 22, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: RC18_0288

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No