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

NCT03754166 | Terminated

• 1 other identifier: RC18_0288
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (1)

• Number of tasks realized per protocol between the two arms

  Variances to a predetermined checklist

  Day 15

Secondary Outcomes (4)

• Arm motor function

  Day 0, Day 15 and Month 3

• Pain evolution

  Day 0, Day 7, Day 15 and Month 3

• Anxiety and Depression evolution

  Day 0, Day 7, Day 15 and Month 3

• Situation of patient after neurovascular unit

  Month 3

Study Arms (2)

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.

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.

Interventions

Constraint-induced movement therapy OTHER

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.

Also known as: Visual-spatial cueing : top down

Constraint-induced movement therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Service de Neurologie, CHU Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Stroke

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Ambre Komonski

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 27, 2018
• Study Start: January 18, 2019
• Primary Completion: February 12, 2020
• Study Completion: February 12, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

FR (1)