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

NCT03237520 | Unknown

• 1 other identifier: VRT with CIMT vs CIMT alone
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hemiparesis

Outcome Measures

Primary Outcomes (1)

• 8 weeks of VRT with mCIMT versus mCIMT alone

  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 Outcomes (10)

• To compare the improvement in the sub domains(dissociated movements, grasp, protective extension and weight bearing) of QUEST score between the 2 groups

  Within 1 week of completing 8 weeks, from the beginning of intervention

• Comparing the improvement in speed of movements between 2 groups

  Within 1 week of completing 8 weeks,from the beginning of intervention

• Comparing the improvement in muscle strength between 2 groups

  Within 1 week of completing 8 weeks,from the beginning of intervention

• Functional Magnetic Resonance Imaging(fMRI) in the 2 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

  Upto 1 week before starting mCIMT+ VRT program and within 1 week of completing 08 weeks, from the beginning of the intervention

Study Arms (2)

Virtual Reality Therapy

EXPERIMENTAL

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

mCIMT

ACTIVE COMPARATOR

Intervention: Modified Constraint Induced Movement Therapy Only mCIMT will be administered using the physical rehabilitation protocol.

Other: mCIMT

Interventions

Virtual Reality Therapy OTHER

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

Virtual Reality Therapy

mCIMT OTHER

Modified constraint induced movement therapy will be provided to all children according to predefined protocol.

mCIMT

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

MeSH Terms

Conditions

Paresis

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Sheffali Gulati, MD

CONTACT

+91-11-26594679; sheffaligulati@gmail.com ; sheffalig@yahoo.com

SHRUTHI N M, MBBS, MD

CONTACT

8585958771; drshrutinm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be masked to the group allocation and the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: An open labeled, randomized controlled, parallel design, superiority trial

Study Record Dates

• First Submitted: July 23, 2017
• First Posted: August 2, 2017
• Study Start: September 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 10, 2017

Record last verified: 2017-08