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NCT Number: NCT06846190

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

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

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Key information

Conditions

Hemiplegic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rising Sun Institute

Lahore, Punjab Province, 54900, Pakistan

Location status: Recruiting

Location contact

Muhammad Asif Javed, MS-PT(Neuro)

CONTACT

[email protected]

923224209422

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mCIMT

Other

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.

VR

Other

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 outcomes

  1. CHEQ (Children's hand-use experience questionnaire)

    Time frame: Baseline, 4th week and 8th week

    CHEQ has been developed to capture children's perceived quality of performance when using the affected hand in these situations. CHEQ is an internet-based questionnaire containing 29 items (bimanual activities) presented one by one in random order. Test-retest reliability for the three CHEQ scale was: grasp efficacy, ICC=0.91; time taken, ICC=0.88; and feeling bothered, ICC=0.91. Total Maximum score of each component (quality, duration & psycho-status) was 100 and total maximum score of hand use was 27. Higher the results showed improvement in hand function

  2. ABILHAND-KIDS questionnaire

    Time frame: Baseline, 4th week and 8th week

    ABILHAND-KIDS questionnaire is a valuable tool to assess a child's unimanual and bimanual upper limb activities. The reliability of the ABILHANDS-Kids is good across different observers as a performance- and capacity-based rating method. Test-retest reliability was 0.92. Total Maximum score was 42, mid score was 21 and minimum score was 0. Higher scores showed improvement in activity level of hand use

Study contacts

Contact information is provided by the study sponsor or research team.

IMRAN AMJAD, PhD

CONTACT

[email protected]

9233224390125

Muhammad Asif Javed, MS-PT

CONTACT

[email protected]

923224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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