HemiplegiaSJCITNCT01447810
Constraint-Induced Movement Therapy in a Pediatric Oncology Population
A study testing Focused rigidity bi-valve long arm cast in people with Hemiplegia and Brain Tumor, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Hemiplegia (weakness or poor muscle function on one side of the body) is a neurological impairment which can occur in children as a result of a brain tumor or related treatment. This impairment can negatively impact the child's functional abilities and movement development, making it difficult for them to play, learn… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Hemiplegia, Brain Tumor
- What is being tested?
- Focused rigidity bi-valve long arm cast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2013
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed hemiplegia of an upper extremity as documented by physician or rehabilitation clinician in the medical record
- Diagnosis of brain tumor
- English speaking
- Participant has demonstrated the ability in the past to move the elbow >70 degrees and has some purposeful movement in the hand (ability to initiate a gross grasp).
- Parent/legal guardian is willing to give consent to participate in the study.
- Child is willing to give assent in the study if seven years old or older.
Who cannot join
- Severe hemiplegia and resulting active range of motion deficits at the affected upper extremity as defined by the following:
- < 30 degrees active shoulder flexion or abduction
- Inability to initiate active elbow flexion or extension.
- Inability to initiate movements at the of wrist, finger or thumb
- Uncontrolled seizures that interfere with daily activities, as this would interfere with the participant's ability to fully participate in the CI Therapy program.
- Pain that significantly interferes with the participant's ability to fully participate in the intensive therapy program. This includes pain related to subluxation of the shoulder, as measured by a pain rating of 5/10 or greater on the FACES or Numeric Pain Scale.
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- Currently receiving oral or intravenous chemotherapy or radiation therapy.
- Inability or unwillingness of legal guardian to give written informed consent.
- Child is unwilling to give assent if seven years old or older.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Constraint Induced Movement Therapy in a Pediatric Oncology Population (SJCIT): A Pilot Study
Hemiplegia (weakness or poor muscle function on one side of the body) is a neurological impairment which can occur in children as a result of a brain tumor or related treatment. This impairment can negatively impact the child's functional abilities and movement development, making it difficult for them to play, learn to feed, dress or bathe themselves, and to participate fully in home, daycare, or school environments. Poor movement skills may also impact overall quality of life. Constraint Induced Therapy is a rehabilitation technique which has been found to improve the child's abilities to move their arms following neurological injuries like stroke and traumatic brain injury in both adults and children.
The aim of this study is to evaluate the feasibility of implementing a constraint induced movement therapy program in a small group of children with a brain tumor and hemiplegia. Children who participate in the program may experience improved ability to use their weak arm leading to increased participation in meaningful activity and improved quality of life.
Read the detailed description
Constraint Induced Therapy (CI Therapy) is based on the theory of "learned non-use." Following an event that impacts the brain (stroke, brain injury etc.), the messages from the brain to the arm and the messages from the arm to the brain are interrupted in the area of the brain where the injury occurred and in a small surrounding area. The arm is often inefficient and difficult to use. Over time, even after swelling in the brain decreases, movement of the affected arm continues to be more effortful and the child becomes quite accustomed to completing activities with the unaffected arm only. Additionally, because the child has not used the weak arm for a while, the part of the brain that is ready to receive signals and give commands to the arm or leg is "quiet" and does not work like it used to. The theory of "learned no-nuse" has lead to the development of the CI Therapy approach which is comprised of the following principles:
- Constraint - the strong or normal arm/leg is restrained, forcing use of the weaker arm/leg during treatment.
- Practiced Use - the weak limb is treated by engaging the child in structured practice of specific movements and functional skills.
- Transfer Package - a home program is developed for the child to use with his or her caregivers that focuses on facilitating carryover of learned skills into the real world environment.
This theory hypothesizes that, because the nervous system, particularly in the child, has plasticity (can be shaped and learn to do new things), CI Therapy will facilitate cortical (brain) reorganization, and help the child overcome learned non-use, eventually leading to improved function of the weak arm or leg.
Phase 1: Initial evaluations will be completed on day 1 of the program. They include interview questions and direct assessment of the participant's ability to use the affected arm as well as to participate in meaningful age-appropriate activities. These assessments include the Motor Activity Log, The Pediatric Arm Function Test, the Inventory of New Motor Activities and Programs, the Pediatric Quality of Life Inventory, and the Preschool Activity Card Sort or Children's Assessment of Activity Preferences.
Phase 2: The participant completes an intensive occupational therapy program which consists of 15 three-hour therapy sessions (5 days per week for 3 weeks). Throughout the three week program the un-involved arm will be constrained with a removable cast. The cast is to be worn 24 hours per day throughout the 3 week program with the exception of regularly scheduled cast changes, washings and skin checks completed by the treating occupational therapist. During the direct intervention sessions, a focus of therapy is on facilitation of new motor skills for the affected arm. Play is utilized as a means to motivate the pediatric participants with activities and exercises specifically chosen to facilitate new motor skills. The program also includes a variety of tools and activities caregivers will complete increasing adherence to the program outside of the direct intervention sessions and to facilitate transfer of affected upper extremity use into the real world environment.
Phase 3: Immediately following the 3 week intervention program the participant's performance is re-assessed. Additionally weekly follow up evaluations are completed by phone for a period of one month. Three months following the intervention program the participant will return for follow up evaluations.
- Conditions
- Hemiplegia, Brain Tumor
- Being tested
- Focused rigidity bi-valve long arm cast
- Keywords
- Constraint-Induced Movement therapy, Pediatric, Hemiplegia, Brain Tumor, Rehabilitation
- Medical subject headings
- Hemiplegia, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused rigidity bi-valve long arm castOther
Also called constraint-induced therapy
Two focused rigidity bi-valve long arm (upper arm to finger tips) casts will be fabricated for each participant on day one of the constraint-induced therapy (CIT) program. Focused rigidity casting materials are water proof and latex/fiberglass free. Focused rigidity casting does not require use of a cast saw for removal thus decreasing potential for anxiety during the casting process. Casts will be fabricated by therapist trained in the casting technique.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Other: Focused rigidity bi-valve long arm cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who complete the study.
To evaluate the feasibility of conducting a 3-week constraint-induced therapy program in patients with upper extremity hemiplegia as a result of a tumor. We will conclude that conducting this constraint induced therapy program is not feasible if more than 2 patients out of eight patients do not complete the program for any reason, with exception those outlined as excused reasons for absence from a therapy sessions (acute illness of the participant, illness of a parent, or other interruptions considered allowable/unavoidable by the study PI).
Measured: One (1) year
Secondary outcomes (2)
Frequency of extremity use.
To describe the change in amount of extremity use at pre-intervention, post-intervention and at follow-up.
Measured: Baseline, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 4 months
Quality of extremity function.
To describe the change in quality of extremity use at pre-intervention, post-intervention and at follow-up.
Measured: Baseline, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Sparrow, OTD, OTR/L, Study chair, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447810
- Sponsor's protocol ID
- SJCIT
- Acronym
- SJCIT
- Status last verified
- Sep 2014
- First submitted
- 4 Oct 2011
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constraint Induced Movement Therapy in a Pediatric Oncology Population (SJCIT): A Pilot Study
- ClinicalTrials.gov ID
- NCT01447810
- Acronym / sponsor ID
- SJCIT / SJCIT
- Conditions
- Hemiplegia, Brain Tumor
- Keywords
- Constraint-Induced Movement therapy, Pediatric, Hemiplegia, Brain Tumor, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Oct 2011 (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.
Hemiplegia (weakness or poor muscle function on one side of the body) is a neurological impairment which can occur in children as a result of a brain tumor or related treatment. This impairment can negatively impact the child's functional abilities and movement development, making it difficult for them to play, learn to feed, dress or bathe themselves, and to participate fully in home, daycare, or school environments. Poor movement skills may also impact overall quality of life. Constraint Induced Therapy is a rehabilitation technique which has been found to improve the child's abilities to move their arms following neurological injuries like stroke and traumatic brain injury in both adults and children.
The aim of this study is to evaluate the feasibility of implementing a constraint induced movement therapy program in a small group of children with a brain tumor and hemiplegia. Children who participate in the program may experience improved ability to use their weak arm leading to increased participation in meaningful activity and improved quality of life.
Detailed description
Constraint Induced Therapy (CI Therapy) is based on the theory of "learned non-use." Following an event that impacts the brain (stroke, brain injury etc.), the messages from the brain to the arm and the messages from the arm to the brain are interrupted in the area of the brain where the injury occurred and in a small surrounding area. The arm is often inefficient and difficult to use. Over time, even after swelling in the brain decreases, movement of the affected arm continues to be more effortful and the child becomes quite accustomed to completing activities with the unaffected arm only. Additionally, because the child has not used the weak arm for a while, the part of the brain that is ready to receive signals and give commands to the arm or leg is "quiet" and does not work like it used to. The theory of "learned no-nuse" has lead to the development of the CI Therapy approach which is comprised of the following principles:
- Constraint - the strong or normal arm/leg is restrained, forcing use of the weaker arm/leg during treatment.
- Practiced Use - the weak limb is treated by engaging the child in structured practice of specific movements and functional skills.
- Transfer Package - a home program is developed for the child to use with his or her caregivers that focuses on facilitating carryover of learned skills into the real world environment.
This theory hypothesizes that, because the nervous system, particularly in the child, has plasticity (can be shaped and learn to do new things), CI Therapy will facilitate cortical (brain) reorganization, and help the child overcome learned non-use, eventually leading to improved function of the weak arm or leg.
Phase 1: Initial evaluations will be completed on day 1 of the program. They include interview questions and direct assessment of the participant's ability to use the affected arm as well as to participate in meaningful age-appropriate activities. These assessments include the Motor Activity Log, The Pediatric Arm Function Test, the Inventory of New Motor Activities and Programs, the Pediatric Quality of Life Inventory, and the Preschool Activity Card Sort or Children's Assessment of Activity Preferences.
Phase 2: The participant completes an intensive occupational therapy program which consists of 15 three-hour therapy sessions (5 days per week for 3 weeks). Throughout the three week program the un-involved arm will be constrained with a removable cast. The cast is to be worn 24 hours per day throughout the 3 week program with the exception of regularly scheduled cast changes, washings and skin checks completed by the treating occupational therapist. During the direct intervention sessions, a focus of therapy is on facilitation of new motor skills for the affected arm. Play is utilized as a means to motivate the pediatric participants with activities and exercises specifically chosen to facilitate new motor skills. The program also includes a variety of tools and activities caregivers will complete increasing adherence to the program outside of the direct intervention sessions and to facilitate transfer of affected upper extremity use into the real world environment.
Phase 3: Immediately following the 3 week intervention program the participant's performance is re-assessed. Additionally weekly follow up evaluations are completed by phone for a period of one month. Three months following the intervention program the participant will return for follow up evaluations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Focused rigidity bi-valve long arm cast |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosed hemiplegia of an upper extremity as documented by physician or rehabilitation clinician in the medical record
- Diagnosis of brain tumor
- English speaking
- Participant has demonstrated the ability in the past to move the elbow >70 degrees and has some purposeful movement in the hand (ability to initiate a gross grasp).
- Parent/legal guardian is willing to give consent to participate in the study.
Key exclusion criteria (9 listed)
- Severe hemiplegia and resulting active range of motion deficits at the affected upper extremity as defined by the following:
- Uncontrolled seizures that interfere with daily activities, as this would interfere with the participant's ability to fully participate in the CI Therapy program.
- Pain that significantly interferes with the participant's ability to fully participate in the intensive therapy program. This includes pain related to subluxation of the shoulder, as measured by a pain rating of 5/10 or greater on the FACES or Numeric Pain Scale.
- Currently receiving oral or intravenous chemotherapy or radiation therapy.
- Inability or unwillingness of legal guardian to give written informed consent.
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 |
|---|---|---|
| Focused rigidity bi-valve long arm castAlso: constraint-induced therapyTwo focused rigidity bi-valve long arm (upper arm to finger tips) casts will be fabricated for each participant on day one of the constraint-induced therapy (CIT) program. Focused rigidity casting materials are water proof and latex/fiberglass free. Focused rigidity casting does not require use of a cast saw for removal thus decreasing potential for anxiety during the casting process. Casts will be fabricated by therapist trained in the casting technique. | Other | Treatment |
Primary outcome
Number of participants who complete the study.
Time frame: One (1) year
To evaluate the feasibility of conducting a 3-week constraint-induced therapy program in patients with upper extremity hemiplegia as a result of a tumor. We will conclude that conducting this constraint induced therapy program is not feasible if more than 2 patients out of eight patients do not complete the program for any reason, with exception those outlined as excused reasons for absence from a therapy sessions (acute illness of the participant, illness of a parent, or other interruptions considered allowable/unavoidable by the study PI).
2 secondary outcomes
Frequency of extremity use.
Time frame: Baseline, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 4 months
Quality of extremity function.
Time frame: Baseline, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 4 months
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 14 Jan 2015.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Jessica Sparrow, OTD, OTR/L study chair
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused rigidity bi-valve long arm cast in people with Hemiplegia and Brain Tumor, run by St. Jude Children's Research Hospital 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 6 inclusion and 9 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 14 Jan 2015. 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?
Number of participants who complete the study. (time frame: One (1) year). 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 14 Jan 2015.