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Recruiting NCT06846190

Modified Constraint Induced Movement Therapy Versus Virtual Reality Training in Children With Cerebral Palsy

No phase Interventional Hemiplegic Cerebral Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mCIMT, VR.
Who it may be relevant to
Registry conditions: Hemiplegic Cerebral Palsy. Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Modified Constraint Induced Movement Therapy Versus Virtual Reality Training in Children With Hemiplegic Cerebral Palsy

Overview

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

Interventions

  • Other mCIMT
    mCIMT+ Hot pack will be applied and unaffected hand will be immobilized by a volar resting splint extending from finger tips to the proximal forearm. Use splint every day for at least 5 waking hours daily for 4 weeks and perform daily activities. Program of mCIMT every other day, 3 times per week during a 4-week period.
  • Other VR
    VR+ Hot pack will be applied. 25 minutes of VR program, every other day, 3 times per week for 4 weeks. Each VR session continued for 10 minutes then 5 minutes rest after that again 10 minutes VR session will do.

Primary outcome measures

  • CHEQ (Children's hand-use experience questionnaire) [Time frame: Baseline, 4th week and 8th week]
  • ABILHAND-KIDS questionnaire [Time frame: Baseline, 4th week and 8th week]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Pakistan · 1 center
  • Rising Sun Institute — Lahore

Publications

  • 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. PMID 32892679
  • 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. PMID 31661938
  • 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. PMID 31658111
  • 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. PMID 30064396
  • Harb A, Margetis K, Kishner S. Modified Ashworth Scale. 2025 Apr 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554572/ PMID 32119459

Identifiers

NCT: NCT06846190 · REC/RCR/AHS/22/maria amjad

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗