Hemiparesis Clinical Trial
Official title:
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.
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.
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