Physiotherapy/hypnosis for AVC Patients

NCT06885294 | Enrolling By Invitation

• 1 other identifier: 2022-306
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Keywords

Hypnosis, Stroke, physiotherapy

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

Group 1 receiving physiotherapy only

EXPERIMENTAL

Stroke patients will receive physiotherapy of upper limbs

Behavioral: Physiotherapy

Group 2 receiving combined physiotherapy and hypnosis

EXPERIMENTAL

Stroke patients will receive physiotherapy of upper limbs under hypnosis

Behavioral: Physiotherapy and Hypnosis

Waitlist group 3 receiving delayed combined physiotherapy and hypnosis

EXPERIMENTAL

Stroke patients will receive physiotherapy of upper limbs under hypnosis one month after the other groups

Behavioral: Control group Physiotherapy and Hypnosis

Interventions

Physiotherapy BEHAVIORAL

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.

Group 1 receiving physiotherapy only

Physiotherapy and Hypnosis BEHAVIORAL

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.

Group 2 receiving combined physiotherapy and hypnosis

Control group Physiotherapy and Hypnosis BEHAVIORAL

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.

Waitlist group 3 receiving delayed combined physiotherapy and hypnosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

GIGA Science and Perception Research Group CHU Liège

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy Modalities; Hypnosis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Mind-Body Therapies; Complementary Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Audrey Vanhaudenhuyse, PhD

  University of Liege

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: March 20, 2025
• Study Start: March 18, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)