Physiotherapy/hypnosis for AVC Patients

Impact of Physiotherapy Combined to Hypnosis on Superior Limb Functional Capacities of AVC Patients

Impact of physical therapy with hypnosis on the functional capacity of the upper limb in stroked patients.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Physiotherapy; Behavioral: Physiotherapy and Hypnosis; Behavioral: Control group Physiotherapy and Hypnosis

Detailed Description

The cerebrovascular accident (CVA) is a pathology generating many disabled people. Physiotherapy is one of the usual rehabilitation techniques for a patient with sequelae of ischemia or cerebral hemorrhage. Combined with another therapeutic approach, hypnosis, it could increase the patient's motor performance.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • GIGA Science and Perception Research Group CHU Liège

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 to 80 years old
• Having experienced a stroke more than 3 months ago
• Understanding and proficient in the French language
• Having a functional capacity deficit in at least one of the two upper limbs
• Being able to independently travel to the Yerne medical center for necessary study appointments.

Exclusion Criteria:

• Being under 18 or over 80 years old
• Having a history of upper limb injuries (fractures, prosthetics, etc.)
• Having Wernicke's aphasia (language comprehension disorder)
• Having frontal lobe syndrome
• Undergoing chemotherapy
• Having respiratory disorders (respiratory failure of more than 70%) or receiving oxygen therapy
• Having epilepsy
• Having dementia
• Having untreated hearing impairments
• Being diagnosed with schizophrenia or paranoïa
• Experiencing significant concentration difficulties

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 receiving physiotherapy only; Stroke patients will receive physiotherapy of upper limbs	Behavioral: Physiotherapy; Stroke patients will be randomly assigned to join one of the three groups. The first group will undergo a pre-treatment evaluation, receive 6 sessions of physiotherapy (2 sessions per week, approximately 20-30 minutes each), and undergo a post-treatment evaluation after 1 month. After another month without any treatment, they will undergo a third and final assessment. All evaluations will last approximately 1 hour.
Experimental: Group 2 receiving combined physiotherapy and hypnosis; Stroke patients will receive physiotherapy of upper limbs under hypnosis	Behavioral: Physiotherapy and Hypnosis; Stroke patients will be randomly assigned to join one of the three groups. The second group will undergo a pre-treatment evaluation, receive 6 sessions of physiotherapy combined with hypnosis (2 sessions per week, approximately 20-30 minutes each), and undergo a post-treatment evaluation after 1 month. Patients will continue their standard physiotherapy care during these 4 weeks. After another month without any treatment, they will undergo a third and final assessment. All evaluations will last approximately 1 hour.
Experimental: Waitlist group 3 receiving delayed combined physiotherapy and hypnosis; Stroke patients will receive physiotherapy of upper limbs under hypnosis one month after the other groups	Behavioral: Control group Physiotherapy and Hypnosis; The control group will be assessed initially and then after 4 weeks. After the second assessment, they will receive 6 sessions of physiotherapy combined with hypnosis (2 sessions per week, approximately 20-30 minutes each), and undergo a post-treatment evaluation after 1 month. All evaluation sessions will last approximately 1 hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of joint ranges of motion	Measurement of shoulder (flexion, extension, abduction, internal rotation, external rotation), elbow (flexion, extension), wrist (flexion, extension)	8 weeks
assessment of spasticity	Measurement of muscle activation on Ashworth scale (extension and flexion of shoulder, elbow, wrist, fingers, thumb) => 0%-100% (a higher score means a worse outcome)	8 weeks
functional tests for the upper limb	Stroke Upper Limb Capacity Scale (SULCS) => 0%-100% (a higher score means a better outcome); using one forearm as support while sitting; wedging an object between the chest and the upper part of the affected limb; sliding an object across a table while sitting; partially unscrewing a lid; taking a glass of water and drinking it; grabbing a tennis ball presented at a certain height; coming one's hair with the affected upper limb; buttoning; writing	8 weeks
scales for assessing disability and functional independence	Functional Independence Measure (FIM) from complete dependence to independence => 0%-100% (a higher score means a better outcome); personal care; sphincter control; mobility, transfers; locomotion; communication; awareness of the external world	8 weeks
evaluation of muscle strength	Measurement of pathological upper limb strength on MRC scale by group/time/joint/movement => 0%-100% (a higher score means a better outcome); Shoulder Flexion Strength; Shoulder Extension Strength; Shoulder Abduction Strength; Shoulder Internal Rotation Strength; Shoulder External Rotation Strength; Elbow Flexion Strength; Elbow Extension Strength; Wrist Flexion Strength; Wrist Extension Strength; Finger Flexion Strength; Finger Extension Strength; Thumb Flexion Strength; Thumb Extension Strength	8 weeks
Box and Block Test (BBT)	Measurement of manual dexterity and motor skills by moving blocks into box comparing healthy upper limb with pathological upper limb => 0%-100% (a higher score means a better outcome)	8 weeks
Modified Rankin Scale (mRS)	Measurement of degree of disability => 0%-100% (a higher score means a worse outcome)	8 weeks

Collaborators and Investigators

• Sponsor: University of Liege
• Investigators: Study Director: Audrey Vanhaudenhuyse, PhD, University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Hypnosis, Stroke, physiotherapy
• Other Study ID Numbers: 2022-306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No