StrokeNCT06885294
Physiotherapy/hypnosis for AVC Patients
A study testing Physiotherapy and Physiotherapy and Hypnosis in people with Stroke, run by University of Liege at 1 site in Belgium.
Trial summary
Impact of physical therapy with hypnosis on the functional capacity of the upper limb in stroked patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Physiotherapy and Physiotherapy and Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Mar 2023to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- Having epilepsy
- Having dementia
- Having untreated hearing impairments
- Being diagnosed with schizophrenia or paranoïa
- Experiencing significant concentration difficulties
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
GIGA Science and Perception Research Group CHU Liège
Liège, 4000
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Physiotherapy, Physiotherapy and Hypnosis, Control group Physiotherapy and Hypnosis
- Keywords
- Hypnosis, Stroke, physiotherapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyBehavioural
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 HypnosisBehavioural
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 HypnosisBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 receiving physiotherapy only | Experimental | Stroke patients will receive physiotherapy of upper limbs Receives: Behavioral: Physiotherapy |
| Group 2 receiving combined physiotherapy and hypnosis | Experimental | Stroke patients will receive physiotherapy of upper limbs under hypnosis Receives: 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 Receives: Behavioral: Control group Physiotherapy and Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of joint ranges of motion
Measurement of shoulder (flexion, extension, abduction, internal rotation, external rotation), elbow (flexion, extension), wrist (flexion, extension)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 8 weeks
Modified Rankin Scale (mRS)
Measurement of degree of disability => 0%-100% (a higher score means a worse outcome)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start18 Mar 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Audrey Vanhaudenhuyse, University of Liege
- Investigators
- Audrey Vanhaudenhuyse, PhD, Study director, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885294
- Sponsor's protocol ID
- 2022-306
- Status last verified
- Feb 2025
- First submitted
- 8 Apr 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physiotherapy Combined to Hypnosis on Superior Limb Functional Capacities of AVC Patients
- ClinicalTrials.gov ID
- NCT06885294
- Acronym / sponsor ID
- 2022-306
- Conditions
- Stroke
- Keywords
- Hypnosis, Stroke, physiotherapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 18 Mar 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Impact of physical therapy with hypnosis on the functional capacity of the upper limb in stroked patients.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 receiving physiotherapy only | Experimental | Behavioral: PhysiotherapyStroke patients will receive physiotherapy of upper limbs |
| Group 2 receiving combined physiotherapy and hypnosis | Experimental | Behavioral: Physiotherapy and HypnosisStroke patients will receive physiotherapy of upper limbs under hypnosis |
| Waitlist group 3 receiving delayed combined physiotherapy and hypnosis | Experimental | Behavioral: Control group Physiotherapy and HypnosisStroke patients will receive physiotherapy of upper limbs under hypnosis one month after the other groups |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyStroke 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. | Behavioural | Group 1 receiving physiotherapy only |
| Physiotherapy and HypnosisStroke 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. | Behavioural | Group 2 receiving combined physiotherapy and hypnosis |
| Control group Physiotherapy and HypnosisThe 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. | Behavioural | Waitlist group 3 receiving delayed combined physiotherapy and hypnosis |
Primary outcome
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)
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)
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
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
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
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)
Modified Rankin Scale (mRS)
Time frame: 8 weeks
Measurement of degree of disability => 0%-100% (a higher score means a worse outcome)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Audrey Vanhaudenhuyse, PhD study director
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy and Physiotherapy and Hypnosis in people with Stroke, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of joint ranges of motion (time frame: 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.