Cerebral Palsy Spastic HemiplegicNCT07853937
Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.
A study testing Rehabilitation intervention in people with Cerebral Palsy Spastic Hemiplegic and Functionnal Neurological Disorder, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
Trial summary
Cerebral palsy (CP) causes persistent motor and postural impairments that can limit children's functional independence and participation. Upper-limb rehabilitation traditionally relies on conventional therapies, while Virtual Reality (VR) provides an immersive, engaging environment that can improve motor function and… Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Cerebral Palsy Spastic Hemiplegic, Functionnal Neurological Disorder, Upper Limb Functions
- What is being tested?
- Rehabilitation intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Oct 2026to 28 Feb 2027
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Able to handle objects in daily life within levels I, II and III on the Gross Motor Function Classification System.
- Absence of musculoskeletal disorders that impaired the ability of children to use the VR system.
- Normal or corrected hearing and vision.
- Able to understand and follow simple directions and perform requested tasks.
- Tutor Consent.
Who cannot join
- Dizziness during VR sessions.
- Intolerance to VR environments.
- Unable to continue or follow the CIMT or VR program.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site
Department of PMR Sousse
Sousse, 4000
saoussen layouni, 52785163, layouni.saoussen@FAMSO.u-sousse.tn
About this study
Official title: Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy: A Randomized Controlled Trial.
Cerebral palsy (CP) causes persistent motor and postural impairments that can limit children's functional independence and participation. Upper-limb rehabilitation traditionally relies on conventional therapies, while Virtual Reality (VR) provides an immersive, engaging environment that can improve motor function and quality of life. Constraint-Induced Movement Therapy (CIMT) promotes intensive use of the affected upper limb and has demonstrated benefits in motor and functional outcomes. Recent evidence suggests that combining VR with CIMT (VRCIT) may further improve upper-limb function, hand manipulation, and dexterity. However, in Tunisia, access to CIMT and VR-based rehabilitation remains limited, and no Tunisian study has yet evaluated the effectiveness of VRCIT in children with unilateral CP, highlighting an important research gap.
Aim: Evaluate the effectiveness of Virtual Reality-Augmented Constraint-Induced Movement Therapy and constraint-induced movement therapy only in improving unimanual upper limb function in children with unilateral cerebral palsy.
- Conditions
- Cerebral Palsy Spastic Hemiplegic, Functionnal Neurological Disorder, Upper Limb Functions, Virtual Reality Based Therapy, Constraint Induced Movement Therapy
- Being tested
- Rehabilitation intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation interventionOther
All participants will undergo two assessment sessions, one at baseline and one at the end of the program.
Clinical testing will consist of physical examination, assessing unimanual function through the Melbourne Assessment 2 (MA2), unilateral gross manual dexterity (The Box and blocks Test), spasticity through the Modified Ashworth Scale (MAS) for elbow and wrist, muscle strength grading (MRC), upper limb passive range of motion (PROM), and bimanual ability through ABILHANDS-KIDS questionnaire.
The clinical outcome measures will be recorded by a researcher-resident in physical medicine and rehabilitation.
After obtaining the oral consent of the participants' legal guardians, those who met the inclusion criteria will be divided in two groups: The first group will receive a CIMT program, the second group will undergo a VRCIT based-rehabilitation program, both for a period of two weeks. A clinical evaluation will be performed one day before the program.
| Study group | Role | What they receive |
|---|---|---|
| 30 children between 5 to 14 years diagnosed with spastic hemiplegic cerebral palsy. | Experimental | Not described Receives: Other: Rehabilitation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Melbourne Assessment 2 (MA2)
The Melbourne Assessment 2 (MA2) is a standardized assessment tool used to evaluate the quality of unilateral (one-sided) upper limb function in children with neurological impairments. It focuses on assessing the range of movement, accuracy, dexterity, and fluency of the child's upper limb during specific tasks.
It reports a child's performance as four separate percentage scores corresponding to each measured element of movement quality.
Measured: before and immediately after the intervention
Secondary outcomes (5)
Spasticity
Spasticity through the Modified Ashworth Scale (MAS) for elbow and wrist ranging from 0 (normal tone) to 4 (rigid).
Measured: before and immediately after intervention
Muscle strength
Muscle strength grading (MRC) ranging from 0 (no muscle activation) to 5 (normal muscle strength with full power against maximal resistance and a complete range of motion).
Measured: before and immediately after intervention
Passive Range of Motion
Upper limb passive range of motion (PROM) in degrees measured with a goniometer.
Measured: before and immediately after intervention
The Box and Blocks Test
Unilateral gross manual dexterity (The Box and blocks Test) for the affected limb scored by counting the total number of blocks safely transferred from one compartment to the other in 60 seconds (number of blocks per minute).
Measured: before and immediately after intervention
ABILHANDS-KIDS questionnaire
Bimanual ability to manage daily life activities through ABILHANDS-KIDS questionnaire ranging from 0 to 42, with each task is assessed as "easy", "difficult" or "impossible". Raw scores are converted through a psychometric analysis (Rasch model) into a linear measure in logits on a continuous scale.
Higher score: Indicates a better manual ability and greater independence in daily life activities requiring the use of both hands.
Lower score: Reveals a significant activity limitation and an increased need for assistance in personal care.
Measured: before and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy Spastic HemiplegicStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine, Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saoussen Layouni, Faculty of Medicine, Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853937
- Sponsor's protocol ID
- Department of PMR Sousse
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07853937
- Acronym / sponsor ID
- Department of PMR Sousse
- Conditions
- Cerebral Palsy Spastic Hemiplegic, Functionnal Neurological Disorder, Upper Limb Functions, Virtual Reality Based Therapy, Constraint Induced Movement Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Faculty of Medicine, SousseUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 2 Oct 2026 (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.
Cerebral palsy (CP) causes persistent motor and postural impairments that can limit children's functional independence and participation. Upper-limb rehabilitation traditionally relies on conventional therapies, while Virtual Reality (VR) provides an immersive, engaging environment that can improve motor function and quality of life. Constraint-Induced Movement Therapy (CIMT) promotes intensive use of the affected upper limb and has demonstrated benefits in motor and functional outcomes. Recent evidence suggests that combining VR with CIMT (VRCIT) may further improve upper-limb function, hand manipulation, and dexterity. However, in Tunisia, access to CIMT and VR-based rehabilitation remains limited, and no Tunisian study has yet evaluated the effectiveness of VRCIT in children with unilateral CP, highlighting an important research gap.
Aim: Evaluate the effectiveness of Virtual Reality-Augmented Constraint-Induced Movement Therapy and constraint-induced movement therapy only in improving unimanual upper limb function in children with unilateral cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30 children between 5 to 14 years diagnosed with spastic hemiplegic cerebral palsy. | Experimental | Other: Rehabilitation intervention |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Able to handle objects in daily life within levels I, II and III on the Gross Motor Function Classification System.
- Absence of musculoskeletal disorders that impaired the ability of children to use the VR system.
- Normal or corrected hearing and vision.
- Able to understand and follow simple directions and perform requested tasks.
- Tutor Consent.
Key exclusion criteria (3 listed)
- Dizziness during VR sessions.
- Intolerance to VR environments.
- Unable to continue or follow the CIMT or VR program.
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 |
|---|---|---|
| Rehabilitation interventionAll participants will undergo two assessment sessions, one at baseline and one at the end of the program. Clinical testing will consist of physical examination, assessing unimanual function through the Melbourne Assessment 2 (MA2), unilateral gross manual dexterity (The Box and blocks Test), spasticity through the Modified Ashworth Scale (MAS) for elbow and wrist, muscle strength grading (MRC), upper limb passive range of motion (PROM), and bimanual ability through ABILHANDS-KIDS questionnaire. The clinical outcome measures will be recorded by a researcher-resident in physical medicine and rehabilitation. After obtaining the oral consent of the participants' legal guardians, those who met the inclusion criteria will be divided in two groups: The first group will receive a CIMT program, the second group will undergo a VRCIT based-rehabilitation program, both for a period of two weeks. A clinical evaluation will be performed one day before the program. | Other | 30 children between 5 to 14 years diagnosed with spastic hemiplegic cerebral palsy. |
Primary outcome
The Melbourne Assessment 2 (MA2)
Time frame: before and immediately after the intervention
The Melbourne Assessment 2 (MA2) is a standardized assessment tool used to evaluate the quality of unilateral (one-sided) upper limb function in children with neurological impairments. It focuses on assessing the range of movement, accuracy, dexterity, and fluency of the child's upper limb during specific tasks. It reports a child's performance as four separate percentage scores corresponding to each measured element of movement quality.
5 secondary outcomes
Spasticity
Time frame: before and immediately after intervention
Muscle strength
Time frame: before and immediately after intervention
Passive Range of Motion
Time frame: before and immediately after intervention
The Box and Blocks Test
Time frame: before and immediately after intervention
ABILHANDS-KIDS questionnaire
Time frame: before and immediately after intervention
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 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation intervention in people with Cerebral Palsy Spastic Hemiplegic and Functionnal Neurological Disorder, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
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 3 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: opening soon, as of the sponsor's last update on 16 Oct 2026. 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 Tunisia. 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?
Contact Saoussen Layouni, Associate professor (52785163, layouni.saoussen@FAMSO.u-sousse.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Melbourne Assessment 2 (MA2) (time frame: before and immediately after the intervention). 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 16 Oct 2026.