Clinical trial NCT06846190: Modified Constraint Induced Movement Therapy Versus Virtual Reality Training in Children With Cerebral Palsy
Official title: Effects of Modified Constraint Induced Movement Therapy Versus Virtual Reality Training in Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Keywords: Cerebral palsy
Hemiplegic
Modified constraint induced movement therapy
Spastic
Virtual reality
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized clinical trial performed, in which 20 hCP children with the age of 5-16 years will be taken randomly after screening and meeting inclusion criteria. Children will be divided in two groups. Group 1 will receive mCIMT for 5 hours in a day with alternating 3 days a week. Group 2 will receive VR for 25 min in a day with alternating 3 days a week. Pre values were taken at 1st week and then after 4th week mid values of interventions will be taken and post values of intervention will be taken after 8th week of intervention to measure the effects of both therapies.
Primary purpose: OTHER

Brief summary: Children with hemiplegic cerebral palsy (CP) are characterized by motor impairments mainly lateralized to one side of the body, with greater upper limb than lower limb involvement; these impairments may further limit the daily activities and school participation of children with hemiplegic CP. For the improvement of activity limitations in hemipelagic cerebral palsy children will take 20 hemiplegic cerebral palsy children with the age of 5-16 year all participants will be randomly assign and use modified Constraint induced movement therapy and virtual reality techniques.

mCIMT and Hot pack will be given to group I and unaffected hand will immobilized by a volar resting splint extending from finger tips to the proximal forearm. Use splint every day for at least 5 waking hours individualized, 18-hour program of mCIMT every other day, 3 times per week during a 4-week period. Each modified CIMT session continued for 1.5 hours will give to group I on the other hand VR and Hot pack will give to group II and 18-hour VR program, every other day, 3 times per week for 4 weeks will give Each VR session continued for 1.5 hours. Then evaluate both groups on follow up.

All the data will be collected from Rising Sun Institute by using ABILHAND-KIDS questionnaire and Children's hand-use experience questionnaire. The reliability and validity of tools and mentioned.

The duration of study will be 6-months. Data will be analyzed with the help of SPSS 27


Eligibility criteria: Inclusion Criteria:

* Age range between 5 to 16 years of age.
* Medical diagnosis of spastic hemiparetic CP.
* At least 20◦wrist and 10◦ active finger extension from full flexion.
* More movement deficits in 1 upper extremity (less than 2.5 on the Amount of Use scale (AOU) on the Pediatric Motor Activity Log (PMAL)).
* Muscle tone less than 3 on the Modified Ashworth Scale.
* Normal or corrected-to-normal vision and hearing.
* Classified level I, II, or III of the Manual Ability Classification System ( MACS) for Children with CP

Exclusion Criteria:

* Health problems not associated with CP.
* Seizure hemispatial neglect.
* Orthopaedic surgery on the involved upper extremity.
* Botulinum toxin therapy for the affected upper extremity within the past 6 months or within the study period.
* Balance problems

Primary outcomes:
measure: CHEQ (Children's hand-use experience questionnaire)
timeFrame: Baseline, 4th week and 8th week
measure: ABILHAND-KIDS questionnaire
timeFrame: Baseline, 4th week and 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Rising Sun Institute
state: Punjab
Study officials:
affiliation: Riphah International University
name: Maria Amjad, MS-PPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberts H, Shierk A, Clegg NJ, Baldwin D, Smith L, Yeatts P, Delgado MR. Constraint Induced Movement Therapy Camp for Children with Hemiplegic Cerebral Palsy Augmented by Use of an Exoskeleton to Play Games in Virtual Reality. Phys Occup Ther Pediatr. 2021;41(2):150-165. doi: 10.1080/01942638.2020.1812790. Epub 2020 Sep 7.
citation: Wu J, Loprinzi PD, Ren Z. The Rehabilitative Effects of Virtual Reality Games on Balance Performance among Children with Cerebral Palsy: A Meta-Analysis of Randomized Controlled Trials. Int J Environ Res Public Health. 2019 Oct 28;16(21):4161. doi: 10.3390/ijerph16214161.
citation: Aran OT, Sahin S, Kose B, Agce ZB, Kayihan H. Effectiveness of the virtual reality on cognitive function of children with hemiplegic cerebral palsy: a single-blind randomized controlled trial. Int J Rehabil Res. 2020 Mar;43(1):12-19. doi: 10.1097/MRR.0000000000000378.
citation: Simon-Martinez C, Mailleux L, Ortibus E, Fehrenbach A, Sgandurra G, Cioni G, Desloovere K, Wenderoth N, Demaerel P, Sunaert S, Molenaers G, Feys H, Klingels K. Combining constraint-induced movement therapy and action-observation training in children with unilateral cerebral palsy: a randomized controlled trial. BMC Pediatr. 2018 Jul 31;18(1):250. doi: 10.1186/s12887-018-1228-2.
citation: Harb A, Margetis K, Kishner S. Modified Ashworth Scale. 2025 Apr 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554572/