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

NCT ID: NCT06846190

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-15

Study Completion Date

2025-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Hemiplegic Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment

Study Groups

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mCIMT group

Clinical experimental: For group -I mCIMT at least 5 waking hours daily for 4 weeks 3 times per week during a 4-week period.

Group Type EXPERIMENTAL

mCIMT

Intervention Type 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 Group

Clinical experimental: For group -II VR 25 minutes of VR program, every other day, 3 times per week for 4 weeks.

Group Type ACTIVE_COMPARATOR

VR

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Amjad, MS-PPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Rising Sun Institute

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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IMRAN AMJAD, PhD

Role: CONTACT

9233224390125

Muhammad Asif Javed, MS-PT

Role: CONTACT

923224209422

Facility Contacts

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Muhammad Asif Javed, MS-PT(Neuro)

Role: primary

923224209422

References

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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.

Reference Type BACKGROUND
PMID: 32892679 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31661938 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31658111 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30064396 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 32119459 (View on PubMed)

Other Identifiers

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REC/RCR/AHS/22/maria amjad

Identifier Type: -

Identifier Source: org_study_id

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