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Enrolling by Invitation

NCT Number: NCT06885294

Physiotherapy/hypnosis for AVC Patients

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GIGA Science and Perception Research Group CHU Liège

Liège, 4000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Measurement of joint ranges of motion

    Time frame: 8 weeks

    Measurement of shoulder (flexion, extension, abduction, internal rotation, external rotation), elbow (flexion, extension), wrist (flexion, extension)

  2. assessment of spasticity

    Time frame: 8 weeks

    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)

  3. functional tests for the upper limb

    Time frame: 8 weeks

    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

  4. scales for assessing disability and functional independence

    Time frame: 8 weeks

    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

  5. evaluation of muscle strength

    Time frame: 8 weeks

    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

  6. Box and Block Test (BBT)

    Time frame: 8 weeks

    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)

  7. Modified Rankin Scale (mRS)

    Time frame: 8 weeks

    Measurement of degree of disability => 0%-100% (a higher score means a worse outcome)

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 20, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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