Cerebral PalsyNCT06506682
Comparing CIMT With Virtual Reality to CIMT
A study testing Constraint Induced Movement Therapy and CIMT + VR in people with Cerebral Palsy, run by Texas Scottish Rite Hospital for Children at 1 site in United States.
Trial summary
This study is being done to compare constraint induced movement therapy (CIMT) to CIMT combined with virtual reality technology (CIMT+VR) and its impact on how the children with unilateral cerebral palsy use their arm. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Constraint Induced Movement Therapy and CIMT + VR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2021to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- have cerebral palsy (a brain injury that causes muscle movement problems) or are a non-progressive brain injury to the developing brain and have difficulty using one of your arms
Who cannot join
- unable to complete assessment protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blinded, Randomized Trial Comparing Constraint Induced Movement Therapy With Virtual Reality to Constraint Induced Movement Therapy Alone and the Correlation of Patient Characteristics With Responsiveness to Intervention
This study is being done to compare constraint induced movement therapy (CIMT) to CIMT combined with virtual reality technology (CIMT+VR) and its impact on how the children with unilateral cerebral palsy use their arm. CIMT is an intensive upper limb therapy for children with one sided (unilateral) cerebral palsy where the child wears a constraint (splint or mit) on their dominant hand so that they use the involved (weaker) side to do activities. Both groups will work on using both arms together to complete activities (bimanual training) as a way to transfer newly learned skills with one hand into two handed tasks. Assessments before and after the intervention will include clinical assessments (where a research team member observes the child doing tasks and ask questions), motion capture (where the child's movement is recorded using multiple cameras), and wearable sensors on the wrists (like a watch).
Read the detailed description
The purpose of this research study is to compare the effectiveness of constraint induced movement therapy (CIMT) to CIMT combined with virtual reality technology (CIMT+VR) in children with unilateral cerebral palsy. Both groups will also work on bimanual training (using both arms together to complete activities) as a way to transfer newly learned skills with one hand into two handed tasks. One group will receive CIMT, and the other group will receive CIMT and the VR technology. CIMT is an intensive upper limb therapy for children with unilateral (one sided) cerebral palsy where the child wears a constraint (splint or mit) on their dominant hand so that they use the involved (weaker) side to do activities. Participants in the CIMT+VR group of this study protocol will do everything the CIMT group does PLUS will utilize at least 4 of the following VR technologies each day of intervention: FitMi, Tyromotion Pablo Upper Extremity, Hocoma Armeo® Spring Pediatric, Nintendo Wii, and Parrot Drone.
FitMi is a neurorehabilitation device that provides visual feedback on motor performance as the individual interacts with wireless switches (Flint Rehab, 2020). The targeted areas of upper limb function for the study include grasp, release, and thumb opposition.
Tyromotion Pablo® Upper Extremity is a sensor based rehabilitation device with interactive therapies for the whole body. It provides targeted training for pronation/supination and force regulation for gross grasp, tip pinch, lateral and three point pinch (Tyromotion). The targeted areas of upper limb function for the study include supination, grip strength, and pinch strength.
Hocoma Armeo® Spring Pediatric is a device that combines the assistance of an exoskeleton and VR games created to improve hand function in the pediatric population. The Hocoma Armeo ® Spring Pediatric encourages repetitive movement of the UL with the aim of increasing quantity and improving quality of movements and can be customized for range of motion and the amount of gravity assistance the exoskeleton provides the child while playing the VR games. The targeted areas of upper limb function for the study include upper arm movement and wrist extension.
Nintendo Wii® is a video game console that uses a handheld pointing device that detects movement in three directions. The system requires the individual to hold the controller in the hand while moving the upper extremity. The targeted areas of upper limb function for the study include stabilize and hold. Parrot Drone is a stable quadcopter mini drone that can be flown indoors and outdoors. It has an autopilot feature that keeps the drone steady even if the user lets go of the controller. The drone can be controlled with a remote control or from a smart device that will target isolated finger and thumb movements.
Participants may exit the study prior to completion of the program due to non-compliance, social and economic barriers, disease progression, misdiagnosis or no longer meeting inclusion criteria. Caregivers may withdraw their child from the study at any time for any reason.
Participants enrolled in the study will complete (1) baseline assessments, including physical assessments with motion capture, which will require a visit to Scottish Rite for Children (SRC), (2) an upper limb intervention program that will require visits to Scottish Rite each weekday for two weeks, and (3) post-intervention assessments, including physical assessments with motion capture, that will require a visit to Scottish Rite, for a total of 12 visits. Assessment visits will each take about 3 hours and group intervention sessions will last 6 hours each day. Participants will also be asked as an option to wear an accelerometer (ActiGraph) on their wrists during waking hours (approximately 12 hours per day) 2-3 days before and after the intervention and during the 2 weeks of intervention for a total of 16-18 days. Total study duration for participants will be about 4 weeks
- Conditions
- Cerebral Palsy
- Being tested
- Constraint Induced Movement Therapy, CIMT + VR
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint Induced Movement TherapyBehavioural
Also called CIMT
CIMT is an intensive upper limb therapy for children with unilateral (one sided) cerebral palsy where the child wears a constraint (splint or mit) on their dominant hand so that they use the involved (weaker) side to do activities
CIMT + VRBehavioural
Participants in the CIMT+VR group of this study protocol will do everything the CIMT group does PLUS will utilize at least 4 of the following VR technologies each day of intervention: FitMi, Tyromotion Pablo® UpperExtremity, Hocoma Armeo® Spring Pediatric, Nintendo Wii, and Parrot Drone.
| Study group | Role | What they receive |
|---|---|---|
| CIMT | Active comparator | Both groups will participate in 60 hours of intensive therapy over 10 days at SRC (6 hours per day Monday-Friday) following the established 'Pirate Camp' CIMT protocol. The full protocol can be found at: https://twu.edu/occupational-therapy/Camp-Based-Augmented-CIMT-Guide/. Both groups will participate in child friendly outdoor and indoor activities that promote the use of the involved side for example; parachute games, sock toss, penny pick up. Receives: Behavioral: Constraint Induced Movement Therapy |
| CIMT+VR | Experimental | The CIMT+VR group will use the VR technology to work on upper limb motor skills for approximately two hours per day (4 of the activities described under Key Information at the beginning of this form) while the CIMT-only group will participate in traditional motor-based task-specific activities. Both the VR games and traditional intervention will target the improvement of the same upper limb domains. Receives: Behavioral: CIMT + VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assisting Hand Assessment (AHA)
assessment of bimanual hand skills in children with cerebral palsy well the involved hand performs during two handed activities,
Measured: Baseline, pre-intervention and immediate post-intervention
Secondary outcomes (7)
Melbourne Unilateral Upper Limb Assessment (MUUL)
how well the involved hand works and active range of motion
Measured: Baseline, pre-intervention and immediate post-intervention
ICF Brief Core Set for Cerebral Palsy
Interview based on ICR Core Set
Measured: Baseline, pre-intervention
Hypertonia Assessment Tool Assessment Tool (HAT)
tone assessment
Measured: Baseline, pre-intervention and immediate post-intervention
Canadian Occupational Performance Measure Occupational Performance Measure (COPM)
Goal setting
Measured: Baseline, pre-intervention and immediate post-intervention
sensory assessment
assess sensory of hand stereognosis, two point discrimination, proprioception,
Measured: Baseline, pre-intervention and immediate post-intervention
motion capture with electromyography (EMG)
while completing the AHA
Measured: Baseline, pre-intervention and immediate post-intervention
option wearing of ActiGraphs on upper limbs
real time tracking of use of upper extremities
Measured: Baseline, pre-intervention and immediate post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start17 May 2021
- Primary completion22 Jul 2022
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Scottish Rite Hospital for Children
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Woman's University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506682
- Sponsor's protocol ID
- STU 2021-0271
- Status last verified
- May 2024
- First submitted
- 29 May 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinded, Randomized Trial Comparing Constraint Induced Movement Therapy With Virtual Reality to Constraint Induced Movement Therapy Alone and the Correlation of Patient Characteristics With Responsiveness to Intervention
- ClinicalTrials.gov ID
- NCT06506682
- Acronym / sponsor ID
- STU 2021-0271
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Texas Scottish Rite Hospital for ChildrenUniversity, hospital or other
- Collaborators
- Texas Woman's University
- Study start
- 17 May 2021 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 17 Jul 2024 (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.
This study is being done to compare constraint induced movement therapy (CIMT) to CIMT combined with virtual reality technology (CIMT+VR) and its impact on how the children with unilateral cerebral palsy use their arm. CIMT is an intensive upper limb therapy for children with one sided (unilateral) cerebral palsy where the child wears a constraint (splint or mit) on their dominant hand so that they use the involved (weaker) side to do activities. Both groups will work on using both arms together to complete activities (bimanual training) as a way to transfer newly learned skills with one hand into two handed tasks. Assessments before and after the intervention will include clinical assessments (where a research team member observes the child doing tasks and ask questions), motion capture (where the child's movement is recorded using multiple cameras), and wearable sensors on the wrists (like a watch).
Detailed description
The purpose of this research study is to compare the effectiveness of constraint induced movement therapy (CIMT) to CIMT combined with virtual reality technology (CIMT+VR) in children with unilateral cerebral palsy. Both groups will also work on bimanual training (using both arms together to complete activities) as a way to transfer newly learned skills with one hand into two handed tasks. One group will receive CIMT, and the other group will receive CIMT and the VR technology. CIMT is an intensive upper limb therapy for children with unilateral (one sided) cerebral palsy where the child wears a constraint (splint or mit) on their dominant hand so that they use the involved (weaker) side to do activities. Participants in the CIMT+VR group of this study protocol will do everything the CIMT group does PLUS will utilize at least 4 of the following VR technologies each day of intervention: FitMi, Tyromotion Pablo Upper Extremity, Hocoma Armeo® Spring Pediatric, Nintendo Wii, and Parrot Drone.
FitMi is a neurorehabilitation device that provides visual feedback on motor performance as the individual interacts with wireless switches (Flint Rehab, 2020). The targeted areas of upper limb function for the study include grasp, release, and thumb opposition.
Tyromotion Pablo® Upper Extremity is a sensor based rehabilitation device with interactive therapies for the whole body. It provides targeted training for pronation/supination and force regulation for gross grasp, tip pinch, lateral and three point pinch (Tyromotion). The targeted areas of upper limb function for the study include supination, grip strength, and pinch strength.
Hocoma Armeo® Spring Pediatric is a device that combines the assistance of an exoskeleton and VR games created to improve hand function in the pediatric population. The Hocoma Armeo ® Spring Pediatric encourages repetitive movement of the UL with the aim of increasing quantity and improving quality of movements and can be customized for range of motion and the amount of gravity assistance the exoskeleton provides the child while playing the VR games. The targeted areas of upper limb function for the study include upper arm movement and wrist extension.
Nintendo Wii® is a video game console that uses a handheld pointing device that detects movement in three directions. The system requires the individual to hold the controller in the hand while moving the upper extremity. The targeted areas of upper limb function for the study include stabilize and hold. Parrot Drone is a stable quadcopter mini drone that can be flown indoors and outdoors. It has an autopilot feature that keeps the drone steady even if the user lets go of the controller. The drone can be controlled with a remote control or from a smart device that will target isolated finger and thumb movements.
Participants may exit the study prior to completion of the program due to non-compliance, social and economic barriers, disease progression, misdiagnosis or no longer meeting inclusion criteria. Caregivers may withdraw their child from the study at any time for any reason.
Participants enrolled in the study will complete (1) baseline assessments, including physical assessments with motion capture, which will require a visit to Scottish Rite for Children (SRC), (2) an upper limb intervention program that will require visits to Scottish Rite each weekday for two weeks, and (3) post-intervention assessments, including physical assessments with motion capture, that will require a visit to Scottish Rite, for a total of 12 visits. Assessment visits will each take about 3 hours and group intervention sessions will last 6 hours each day. Participants will also be asked as an option to wear an accelerometer (ActiGraph) on their wrists during waking hours (approximately 12 hours per day) 2-3 days before and after the intervention and during the 2 weeks of intervention for a total of 16-18 days. Total study duration for participants will be about 4 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIMT | Active comparator | Behavioral: Constraint Induced Movement TherapyBoth groups will participate in 60 hours of intensive therapy over 10 days at SRC (6 hours per day Monday-Friday) following the established 'Pirate Camp' CIMT protocol. The full protocol can be found at: https://twu.edu/occupational-therapy/Camp-Based-Augmented-CIMT-Guide/. Both groups will participate in child friendly outdoor and indoor activities that promote the use of the involved side for example; parachute games, sock toss, penny pick up. |
| CIMT+VR | Experimental | Behavioral: CIMT + VRThe CIMT+VR group will use the VR technology to work on upper limb motor skills for approximately two hours per day (4 of the activities described under Key Information at the beginning of this form) while the CIMT-only group will participate in traditional motor-based task-specific activities. Both the VR games and traditional intervention will target the improvement of the same upper limb domains. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- have cerebral palsy (a brain injury that causes muscle movement problems) or are a non-progressive brain injury to the developing brain and have difficulty using one of your arms
Key exclusion criteria (1 listed)
- unable to complete assessment protocol
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 |
|---|---|---|
| Constraint Induced Movement TherapyAlso: CIMTCIMT is an intensive upper limb therapy for children with unilateral (one sided) cerebral palsy where the child wears a constraint (splint or mit) on their dominant hand so that they use the involved (weaker) side to do activities | Behavioural | CIMT |
| CIMT + VRParticipants in the CIMT+VR group of this study protocol will do everything the CIMT group does PLUS will utilize at least 4 of the following VR technologies each day of intervention: FitMi, Tyromotion Pablo® UpperExtremity, Hocoma Armeo® Spring Pediatric, Nintendo Wii, and Parrot Drone. | Behavioural | CIMT+VR |
Primary outcome
Assisting Hand Assessment (AHA)
Time frame: Baseline, pre-intervention and immediate post-intervention
assessment of bimanual hand skills in children with cerebral palsy well the involved hand performs during two handed activities,
7 secondary outcomes
Melbourne Unilateral Upper Limb Assessment (MUUL)
Time frame: Baseline, pre-intervention and immediate post-intervention
ICF Brief Core Set for Cerebral Palsy
Time frame: Baseline, pre-intervention
Hypertonia Assessment Tool Assessment Tool (HAT)
Time frame: Baseline, pre-intervention and immediate post-intervention
Canadian Occupational Performance Measure Occupational Performance Measure (COPM)
Time frame: Baseline, pre-intervention and immediate post-intervention
sensory assessment
Time frame: Baseline, pre-intervention and immediate post-intervention
motion capture with electromyography (EMG)
Time frame: Baseline, pre-intervention and immediate post-intervention
option wearing of ActiGraphs on upper limbs
Time frame: Baseline, pre-intervention and immediate post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint Induced Movement Therapy and CIMT + VR in people with Cerebral Palsy, run by Texas Scottish Rite Hospital for Children at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Jul 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assisting Hand Assessment (AHA) (time frame: Baseline, pre-intervention and immediate post-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 17 Jul 2024.