Comparing Virtual Reality Therapy With Modified-CIMT Versus Modified-CIMT Alone in Hemiparetic Children

August 8, 2017 updated by: Sheffali Gulati, All India Institute of Medical Sciences, New Delhi

Comparing Efficacy of Virtual Reality Therapy With Modified Constraint Induced Movement Therapy (mCIMT) Versus mCIMT Alone, for 5-18 Years Children With Hemiparetic Cerebral Palsy - An Open Label, Randomized Controlled, Superiority Trial

This study intends to compare the efficacy of of virtual reality therapy(VRT) with modified constraint induced movement therapy(mCIMT) versus modified constraint induced movement therapy alone for children with hemiparetic cerebral palsy aged >/= 5-18 years, in improving the upper limb functions, as measured by the QUEST (Quality of Upper Extremity Skill Test score) over 3 months of intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sample size: Based on the previous studies, on CIMT in hemiparetic CP children using QUEST scores,

  • Anticipated increase in total QUEST scores at 2 months in the mCIMT group:

    10 + 5(mean + SD)

  • Anticipated increase in total QUEST scores at 2 months in the mCIMT+ VRT group:

    15 + 5(mean + SD)

  • Alpha error= 5%
  • Power= 80%
  • Calculated sample size : 23 children in each group
  • Considering loss due to attrition of roughly 25%,investigators would enroll 30 children in each of the two groups.
  • At least 10 children in each group will be analyzed with baseline and follow up fMRI and DTI. These children in each group will be selected through systematic sampling method.

Method:

  • Block randomization in 1:1 ratio with variable block size will be done using computer generated random numbers. These will be generated by the person not involved in the trial. Subjects will be randomized to

    • mCIMT + VRT
    • mCIMT alone
  • Each random number will be kept in an opaque sealed envelope and will be opened only at the time of enrollment of the study subjects.Principal investigator will then enroll the participants, and will assign the participants to interventions. After obtaining informed consent from parents, and assent from the children participating in the trial(whenever possible), of hemiparetic cerebral palsy, subjects will be enrolled in the study as per the inclusion and exclusion criteria. Details for each patient will be recorded in a structured proforma

The total study duration will be 3 months, of which 2 months of supervised intervention will be given.Home based therapy will be continued all through the 3 months of intervention in both the groups.

  • Functional assessment of the upper limbs will be done using QUEST/Nine Hole Peg Board Test/ Hand Held Dynamometer and quality of life by cerebral palsy quality of life(CP-QOL)- child scale. Baseline fMRI(Functional Magnetic Resonance Imaging) and DTI(Diffusion Tensor Imaging) Brain will be performed up to one week before starting intervention.
  • Baseline fMRI and DTI will be done in at least 10 children of each group, selected by systematic sampling method within each group.
  • mCIMT+ VRT program will be initiated within one week of baseline assessment, at the institute(Department of PMR). There will be 12 visits over the duration of intervention for supervised sessions, in each group. It would be twice weekly for 4 weeks followed by once a week for next 4 weeks. Parents will be advised regarding the therapy to be provided at home on these visits. Compliance log will be provided to them at the first visit
  • Compliance log will be checked on each subsequent visit; reinforcement will be provided; video records of one session per week of each item of mCIMT done at home will also be reviewed. Those following regimen for <70 % of the total time recommended for mCIMT each day for at least 21 out of 28 days will be considered to be poorly compliant. Those following regimen for >80% of the total time recommended for mCIMT each day for at least 21 out of 28 days will be considered to have compliance. Those following the regimen for 80-90% of the total time recommended for mCIMT each day for at least 21 out of 28 days will be considered to have fair compliance.Those following the regimen for >90% of the total time recommended for mCIMT each day for at least 21 out of 28 days will be considered to have good compliance.[All children(both with good and poor compliance), will be included in the intention to treat analysis]

CIMT(Control group and intervention group) :

• Sling will be applied to the unaffected arm, as a restraint (sling will be provided free of cost). mCIMT will be performed for 2 hours per session during the scheduled visits(in the control group) and 2 hours every day at home(by both the groups). Functional activities will be carried out by the affected, unrestrained arm under supervision. Repetitive activities and shaping will be practiced. mCIMT will be provided by trained occupational therapist, first investigator and with the caregiver's participation and would be tailor made to each patient. At each visit, the methodology followed at home will be reviewed (log books with/without video records). Reinforcement will be provided at each visit regarding subsequent therapy to be done at home.

VRT(Intervention group only):

  • VRT software and device is developed in collaboration with IIT Delhi using Kinect system. Kinect- motion sensor and computer set up is required. VRT (CIMT in a virtual environment)will be provided for 2 hours at every visit(twice weekly for first 4 weeks, once a week for next 4 weeks). VRT will be provided only during scheduled visits with the same principle as mCIMT. Functional activities like repetition of the tasks and shaping will be performed with the affected hand using VRT and CIMT while the unaffected arm is restrained. At home, 2 hours of modified CIMT will be given daily, as for the control group. At each visit, the methodology of CIMT followed at home is reviewed (log books with/without video records). Reinforcement will be provided at each visit regarding subsequent therapy to be done at home
  • FMRI and DTI will be done within 1 week of completion of 08 weeks of intervention in all those children who have had a baseline fMRI/DTI.
  • After 8 weeks of intervention, children will be followed up again at the end of 12 weeks from the baseline. They will be asked to continue mCIMT daily for 2 hours at home and maintain the daily logs during this period. At this visit, all clinical assessments will be repeated
  • Outcome assessors will be blinded to the study subject's group allocation.
  • Data will be recorded in a pre-designed proforma and managed in an excel spread sheet.All the entries will be checked for any possible key board errors. Statistical analysis will be done using Stata 14.0 statistical software.
  • Intention to treat analysis and per protocol analysis will be done
  • Categorical variables will be summarized by frequency (%) and test of proportions will be used to compare the proportions between the two groups. Quantitative variables will be assessed for approximate normal distribution and these will be denoted as mean+SD or median (Interquartile range/min-max), as appropriate.Student's t test/ Wilcoxon rank sum test will be used to compare the mean value between the two groups at the end of the intervention and at the end of 3 months. In case of any imbalance at the baseline, analysis of covariance(ANCOVA) will be used to compute adjusted mean of the outcome variables bet the two groups and the corresponding effect size(95%CI).In this study p value <0.05 will be considered statistically significant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Children aged >5-18 years
  2. Children with hemiparetic cerebral palsy * (both perinatal and postnatal acquired brain injury)
  3. Intelligence quotient >70 (Binet Kamat Test/Malin's Intelligence Scale for Children)
  4. Modified Ashworth scoring 1-3 for affected limb
  5. Can sit independently or with support (Gross Motor Functional Classification System stage: 1-4 and Manual Ability Classification System stage: 1-3)
  6. Preserved vision and hearing (with or without correction)

Exclusion Criteria:

  1. Uncontrolled epilepsy as defined by seizure frequency >1/month for preceding 3 months
  2. Severe concurrent illness or diseases not associated with CP or unstable medical conditions like pneumonia
  3. Genetic or syndromic associations
  4. Children diagnosed with autistic spectrum disorders
  5. Modified Ashworth scale score more than 3 at shoulder/elbow /wrist
  6. Contractures of the affected limb
  7. Severe movement disorder like dystonia, choreo-athetosis or ballismus interfering with purposeful limb movement
  8. Any congenital brain malformation detected on conventional MRI brain
  9. Recent orthopedic surgery/cast/splint in the affected limb
  10. Botulinum toxin/phenol blocking in the affected limb in the past 6 months or are planning to receive in the study period
  11. Those receiving tone modifying agents in week before enrollment(Tizanidine,baclofen,benzodiazepines,dantrolene)
  12. Any contraindications for MRI - examples- presence of pacemaker, metallic implant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Virtual Reality Therapy
Intervention: Virtual Reality therapy(VRT) reinforcing modified Constraint Induced Movement therapy(mCIMT) VRT will be administered using computer based program. mCIMT will be administered using the physical rehabilitation protocol.
Other: Virtual Reality Therapy
VRT software and device is developed in collaboration with IIT Delhi using Kinect system. Kinect- motion sensor and computer set up is required. VRT (CIMT in a virtual environment)will be provided for 2 hours at every visit(twice weekly for first 4 weeks, once a week for next 4 weeks). VRT will be provided only during scheduled visits with the same principle as mCIMT. Functional activities like repetition of the tasks and shaping will be performed with the affected hand using VRT and CIMT while the unaffected arm is restrained
Active Comparator: mCIMT
Intervention: Modified Constraint Induced Movement Therapy Only mCIMT will be administered using the physical rehabilitation protocol.
Other: mCIMT
Modified constraint induced movement therapy will be provided to all children according to predefined protocol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
8 weeks of VRT with mCIMT versus mCIMT alone
Time Frame: Within 1 week of completing 8 weeks, from the beginning of intervention
The primary objective is to evaluate and compare the efficacy of 8 weeks of modified constraint induced movement therapy (mCIMT) reinforced with virtual reality therapy(VRT) with modified constraint induced movement therapy alone, in improving the upper limb function in >5-18 years old children with hemiparetic cerebral palsy, by using the QUEST scoring(Quality Of Upper Extremity Skill Test Score) in the two groups.
Within 1 week of completing 8 weeks, from the beginning of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To compare the improvement in the sub domains(dissociated movements, grasp, protective extension and weight bearing) of QUEST score between the 2 groups
Time Frame: Within 1 week of completing 8 weeks, from the beginning of intervention
QUEST is the Quality Of Upper Extremity Skill Test. It assesses quality of the dissociated movements, grasp, weight bearing and protective extension. In each group at the end of 8 weeks the QUEST score will be chronicled for each of the domains and compared between the intervention and control group.
Within 1 week of completing 8 weeks, from the beginning of intervention
Comparing the improvement in speed of movements between 2 groups
Time Frame: Within 1 week of completing 8 weeks,from the beginning of intervention
This will be assessed using the nine hole peg board. The difference in change in mean time to complete the nine hole peg board will be compared between the two groups.
Within 1 week of completing 8 weeks,from the beginning of intervention
Comparing the improvement in muscle strength between 2 groups
Time Frame: Within 1 week of completing 8 weeks,from the beginning of intervention
The muscle strength will be assessed by hand held dynamometer. The change in muscle strength measured in pounds by hand held dynamometer will be compared between two groups.
Within 1 week of completing 8 weeks,from the beginning of intervention
Functional Magnetic Resonance Imaging(fMRI) in the 2 groups
Time Frame: Upto 1 week before starting mCIMT+ VRT program and within 1 week of completing 08 weeks, from the beginning of the intervention
To describe functional magnetic resonance imaging(fMRI) changes in a pre-defined motor paradigm of the paretic upper limb in terms of changes in BOLD(Blood Level Oxygen Dependent) cluster activation of ipsilesional (contralteral *) somatosensory cortex; laterality Index of Broadmann Area 4 (BA4) and Broadman area 6 (BA6), and ipsilateral cerebellum activation ratio during the motor task performance of the paretic upper limb in fMRI Brain in both the groups
Upto 1 week before starting mCIMT+ VRT program and within 1 week of completing 08 weeks, from the beginning of the intervention
fMRI changes copared with clinical improvement in 2 groups before and after intervention
Time Frame: Upto 1 week before starting mCIMT+ VRT program and within 1 week of completing 08 weeks, from the beginning of the intervention
This is done by comparing changes in fMRI brain in terms of BOLD cluster activation of contralateral and ipsilateral somatosensory cortex with clinical assessment of upper limb function in terms of QUEST score between the two groups
Upto 1 week before starting mCIMT+ VRT program and within 1 week of completing 08 weeks, from the beginning of the intervention
DTI(Diffusion Tensor Imaging) changes compared with clinical improvement in 2 groups before and after intervention
Time Frame: Upto 1 week before starting mCIMT+ VRT program and within 1 week of completing 08 weeks, from the beginning of the intervention
This is done by comparing changes in diffusion tensor imaging findings in terms of fractional anisotropy value of the lesion with clinical assessment of upper limb function in terms of QUEST scores between the two groups
Upto 1 week before starting mCIMT+ VRT program and within 1 week of completing 08 weeks, from the beginning of the intervention
Diffusion Tensor Imaging changes in 2 groups
Time Frame: Upto 1 week before starting mCIMT+ VRT program and within 1 week of completing 08 weeks, from the beginning of the intervention
To describe changes in Diffusion Tensor Imaging findings in terms of fractional anisotropy value of the lesion between the two groups(performed at baseline, and within one week of completion of 8 weeks of intervention)
Upto 1 week before starting mCIMT+ VRT program and within 1 week of completing 08 weeks, from the beginning of the intervention
Sustained improvement
Time Frame: Baseline and at 12 weeks of intervention
This is done by assessing the difference in change in total QUEST scores at baseline and at 12 weeks of intervention, between the intervention and the control groups, and assessing the persistence of improvement, 4 weeks after stopping supervised intervention.
Baseline and at 12 weeks of intervention
Quality of life improvement
Time Frame: At the end of 8 weeks, from the beginning of intervention
Cerebral Palsy- Quality Of Life scale for children(CP-QOL child) will be applied at baseline and at 8 weeks of intervention. Difference in change in CP-QOL scores at baseline and at 8 weeks of intervention will be compared between two groups.
At the end of 8 weeks, from the beginning of intervention
Compliance
Time Frame: At the end of 8 weeks, from the beginning of intervention
Parents will be asked to maintain daily activity monitoring log. The compliance in two groups will be assessed based on this log.
At the end of 8 weeks, from the beginning of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VRT with CIMT vs CIMT alone

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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