Cerebral PalsyNCT02914925
The Effect of Combined Armeospring and CIT on Neuro-motor and Functional Recovery in Children With Unilateral CP
A study testing ArmeoSpring/CIT in people with Cerebral Palsy and Hemiplegia, run by St Mary's Hospital for Children at 1 site in United States.
Trial summary
The purpose of this study is to assess the use of a commercially available arm weight supporting training system (Armeo®Spring) in conjunction with Constraint Induced Therapy (CIT) for improving upper extremity function for children with unilateral cerebral palsy. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Cerebral Palsy, Hemiplegia, Upper Extremity Weakness
- What is being tested?
- ArmeoSpring/CIT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jan 2018
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with diagnosis of CP hemiplegia
- Children that meet Armeo®Spring Pediatric fit criteria
- Upper arm measures:155mm-235mm (7 to 9.5 inches)
- Lower arm measures: 230mm-370mm
- Children that have the ability to follow instructions.
Who cannot join
- Severe cognitive deficits
- Children with any current medical illness unrelated to CP
- Children with previous episode of neurocardiogenic syncope
- Children with visual problems uncorrected by glasses and contact lens
- History of Botulinum toxin or surgical intervention to the relevant extremity in the previous 6 months
- Children with severe spasticity
Show all 11Show fewer
- Children with severe spontaneous movements-ataxia, myoclonic jerks, dyskinesia
- History of seizure beyond age 2
- History of bone instability, shoulder joint subluxation or pain
- Any child on anti-seizure medications or history of epilepsy in self or first degree relatives
- Any child who has serious heart disease, structural brain lesion,increased intracranial pressure, or has had brain surgery Any child with metals in the body such as cranial metal implants, pacemaker, medication pump, cochlear implant, implanted brain stimulator
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
William Watson
Queens, New York, 11360
William Watson, Ph.D, 718-281-8868, wwatson@stmaryskids.org
William Watson, Ph.D
About this study
Official title: The Effect of Combined Armeospring Pediatric and Constraint Induced Therapy on Neuro-motor and Functional Recovery in Children With Unilateral Cerebral Palsy
The purpose of this study is to assess the use of a commercially available arm weight supporting training system (Armeo®Spring) in conjunction with Constraint Induced Therapy (CIT) for improving upper extremity function for children with unilateral cerebral palsy. In addition, the study aims to assess the potential cortical changes with Armeo®Spring therapy and CIT with the use of the Transcranial Magnetic Stimulation (TMS) motor mapping.
This within-subjects repeated-measures study will be conducted at St. Mary's Hospital for Children. Subjects will be recruited from the general population. A sample size of 10 participants is required for the study. Minority and gender distributions of this study are expected to reflect the distributions in the general population of this region.
Read more
Therapy: Participating children will have their unaffected arm placed in a sling. The sling is placed at the start of the day and the child is encouraged to have this on during all therapy sessions.The affected arm will be used for repetitive therapeutic activities.Therapy sessions will include activities aimed at building motor learning skills.
TMS will be used to map the brain. Participants will have MRI of the brain that is T1 weighted with 0.9 -1.1 voxel. size to allow for on-screen navigation of the cerebral cortex while performing TMS.The stimulating coil will be held to the scalp over each M1 hemisphere and an induced electrical current passed through the coil will create a magnetic pulse that stimulates the brain
Children will be assessed using functional hand tests and TMS.
Read the detailed description
Objective: This study will evaluate the effect of combined Armeo®spring pediatric and Constraint Induced Therapy on neuro-motor and functional recovery in children with unilateral cerebral palsy.
Background: Children with unilateral cerebral palsy (CP) tend not to use their impaired arm and hand throughout life. This disuse of a limb during postnatal development can stunt the activity-dependent structural and functional development of the motor system. Enabling young children to more readily use their affected extremity is likely to increase the competitive ability of the affected side and can improve the functional and anatomical integrity of the motor system.
Several studies have shown that applying a restraint to the less affected hand with intensive repetitive use of the more affected hand has significant effect in overcoming learned non-use. There is evidence that suggests that CIT produced significant cortical reorganization in adults with chronic and sub-acute cerebrovascular accident (CVA) and patients with chronic traumatic brain injury and for the lower limb of patients with CVA.
The associations between motor physiology and motor performance in children with hemiplegic CP are being examined. Recent study shows that children whose impaired hand is controlled by contralateral connections from the unaffected motor cortex show greater improvement to intensive hand training than children whose impaired hand is controlled by ipsilateral connections from the affected motor cortex.
In order for future therapies to be applied selectively to brain regions most important in mediating recovery, it is important to determine the location of plastic changes produced by intensive practice.
Subject Population: Children with CP Hemiplegia
Design: Participating children enrolled will engage in intensive CI therapeutic activities along with 30-45 minutes of Armeo®Spring based activities at progressively increasing levels of difficult, 6 h/day for 5 days a week for three weeks. Each child's performance will be tracked and activities will be modified based on performance.
Hand function would be assessed using functional hands test (AHA, Box \& Blocks test, Jebsen Taylor hand function test) and TMS at three time points: before, after and six months after completion of the training protocol.
Outcome measures: Outcome variables of TMS will be measures of corticomotor excitability using single-pulse TMS. Motor evoked potentials (MEPs) will be recorded via surface electromyography (EMG).
Significance: Understanding how rehabilitation can modulate brain areas associated with motor deficits in CP.
- Conditions
- Cerebral Palsy, Hemiplegia, Upper Extremity Weakness
- Being tested
- ArmeoSpring/CIT
- Keywords
- CIT, ArmeoSpring, TMS
- Medical subject headings
- Cerebral Palsy, Hemiplegia, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArmeoSpring/CITDevice
Participating group will receive therapy with the Armeo®Spring Pediatric and CIT for 6 hours per day, 5 days per week for three weeks, totaling 90 hours
| Study group | Role | What they receive |
|---|---|---|
| ArmeoSpring/CIT | Experimental | Group will receive ArmeoSpring and CIT therapy Receives: Device: ArmeoSpring/CIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor cortical map expansion
Transcranial Magnetic Stimulation (TMS)
Measured: Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy
Change in hand function
Box and Blocks test
Measured: Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy
Change in hand function
Jebsen Taylor Hand Function Test
Measured: Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy
Change in bimanual hand function
Assisting Hand Assessment
Measured: Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Mary's Hospital for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Watson, St Mary's Hospital for Children
- Investigators
- William Watson, Ph.D, Principal investigator, St Mary's Hospital for ChildrenSwetha Krishnaswamy, MS OTR/L, Principal investigator, St Mary's Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914925
- Sponsor's protocol ID
- SMH-001
- Status last verified
- Sep 2016
- First submitted
- 21 Sep 2016
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Liepert J, Bauder H, Wolfgang HR, Miltner WH, Taub E, Weiller C. Treatment-induced cortical reorganization after stroke in humans. Stroke. 2000 Jun;31(6):1210-6. doi: 10.1161/01.str.31.6.1210.
PubMed 10835434Inguaggiato E, Sgandurra G, Perazza S, Guzzetta A, Cioni G. Brain reorganization following intervention in children with congenital hemiplegia: a systematic review. Neural Plast. 2013;2013:356275. doi: 10.1155/2013/356275. Epub 2013 Dec 3.
PubMed 24367726
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Armeospring Pediatric and Constraint Induced Therapy on Neuro-motor and Functional Recovery in Children With Unilateral Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02914925
- Acronym / sponsor ID
- SMH-001
- Conditions
- Cerebral Palsy, Hemiplegia, Upper Extremity Weakness
- Keywords
- CIT, ArmeoSpring, TMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- St Mary's Hospital for ChildrenUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 26 Sep 2016 (estimated)
- 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.
The purpose of this study is to assess the use of a commercially available arm weight supporting training system (Armeo®Spring) in conjunction with Constraint Induced Therapy (CIT) for improving upper extremity function for children with unilateral cerebral palsy. In addition, the study aims to assess the potential cortical changes with Armeo®Spring therapy and CIT with the use of the Transcranial Magnetic Stimulation (TMS) motor mapping.
This within-subjects repeated-measures study will be conducted at St. Mary's Hospital for Children. Subjects will be recruited from the general population. A sample size of 10 participants is required for the study. Minority and gender distributions of this study are expected to reflect the distributions in the general population of this region.
Therapy: Participating children will have their unaffected arm placed in a sling. The sling is placed at the start of the day and the child is encouraged to have this on during all therapy sessions.The affected arm will be used for repetitive therapeutic activities.Therapy sessions will include activities aimed at building motor learning skills.
TMS will be used to map the brain. Participants will have MRI of the brain that is T1 weighted with 0.9 -1.1 voxel. size to allow for on-screen navigation of the cerebral cortex while performing TMS.The stimulating coil will be held to the scalp over each M1 hemisphere and an induced electrical current passed through the coil will create a magnetic pulse that stimulates the brain
Children will be assessed using functional hand tests and TMS.
Detailed description
Objective: This study will evaluate the effect of combined Armeo®spring pediatric and Constraint Induced Therapy on neuro-motor and functional recovery in children with unilateral cerebral palsy.
Background: Children with unilateral cerebral palsy (CP) tend not to use their impaired arm and hand throughout life. This disuse of a limb during postnatal development can stunt the activity-dependent structural and functional development of the motor system. Enabling young children to more readily use their affected extremity is likely to increase the competitive ability of the affected side and can improve the functional and anatomical integrity of the motor system.
Several studies have shown that applying a restraint to the less affected hand with intensive repetitive use of the more affected hand has significant effect in overcoming learned non-use. There is evidence that suggests that CIT produced significant cortical reorganization in adults with chronic and sub-acute cerebrovascular accident (CVA) and patients with chronic traumatic brain injury and for the lower limb of patients with CVA.
The associations between motor physiology and motor performance in children with hemiplegic CP are being examined. Recent study shows that children whose impaired hand is controlled by contralateral connections from the unaffected motor cortex show greater improvement to intensive hand training than children whose impaired hand is controlled by ipsilateral connections from the affected motor cortex.
In order for future therapies to be applied selectively to brain regions most important in mediating recovery, it is important to determine the location of plastic changes produced by intensive practice.
Subject Population: Children with CP Hemiplegia
Design: Participating children enrolled will engage in intensive CI therapeutic activities along with 30-45 minutes of Armeo®Spring based activities at progressively increasing levels of difficult, 6 h/day for 5 days a week for three weeks. Each child's performance will be tracked and activities will be modified based on performance.
Hand function would be assessed using functional hands test (AHA, Box \& Blocks test, Jebsen Taylor hand function test) and TMS at three time points: before, after and six months after completion of the training protocol.
Outcome measures: Outcome variables of TMS will be measures of corticomotor excitability using single-pulse TMS. Motor evoked potentials (MEPs) will be recorded via surface electromyography (EMG).
Significance: Understanding how rehabilitation can modulate brain areas associated with motor deficits in CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ArmeoSpring/CIT | Experimental | Device: ArmeoSpring/CITGroup will receive ArmeoSpring and CIT therapy |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children with diagnosis of CP hemiplegia
- Children that meet Armeo®Spring Pediatric fit criteria
- Upper arm measures:155mm-235mm (7 to 9.5 inches)
- Lower arm measures: 230mm-370mm
- Children that have the ability to follow instructions.
Key exclusion criteria (11 listed)
- Severe cognitive deficits
- Children with any current medical illness unrelated to CP
- Children with previous episode of neurocardiogenic syncope
- Children with visual problems uncorrected by glasses and contact lens
- History of Botulinum toxin or surgical intervention to the relevant extremity in the previous 6 months
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 |
|---|---|---|
| ArmeoSpring/CITParticipating group will receive therapy with the Armeo®Spring Pediatric and CIT for 6 hours per day, 5 days per week for three weeks, totaling 90 hours | Device | ArmeoSpring/CIT |
Primary outcome
Change in motor cortical map expansion
Time frame: Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy
Transcranial Magnetic Stimulation (TMS)
Change in hand function
Time frame: Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy
Box and Blocks test
Change in hand function
Time frame: Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy
Jebsen Taylor Hand Function Test
Change in bimanual hand function
Time frame: Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy
Assisting Hand Assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- Background: PubMed 10835434Liepert J, Bauder H, Wolfgang HR, Miltner WH, Taub E, Weiller C. Treatment-induced cortical reorganization after stroke in humans. Stroke. 2000 Jun;31(6):1210-6. doi: 10.1161/01.str.31.6.1210.
- Background: PubMed 24367726Inguaggiato E, Sgandurra G, Perazza S, Guzzetta A, Cioni G. Brain reorganization following intervention in children with congenital hemiplegia: a systematic review. Neural Plast. 2013;2013:356275. doi: 10.1155/2013/356275. Epub 2013 Dec 3.
- Individual participant dataSharing planned: Yes
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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.
William Watson, Ph.D principal investigator
St Mary's Hospital for Children
Swetha Krishnaswamy, MS OTR/L principal investigator
St Mary's Hospital for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ArmeoSpring/CIT in people with Cerebral Palsy and Hemiplegia, run by St Mary's 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 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: status not confirmed, as of the sponsor's last update on 26 Sep 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William Watson, Ph.D (718-281-8868, wwatson@stmaryskids.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in motor cortical map expansion (time frame: Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02914925, which also lists 2 linked publications.
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 26 Sep 2016.