Vestibular and Motor Functions in Children With Hemiplegic Cerebral Palsy

NCT04894812 | Completed DMC

• 1 other identifier: REC/00757 Anam Tariq
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

As many researches have been conducted to see the effects of vestibular system activation on gross motor activities of children with cerebral palsy but there are limited researches on improvement of motor abilities of hemiplegic cerebral palsy child using UEU or BOSU ball or treadmill in a single study. There is lack of research on vestibular stimulation in hemiplegic cerebral palsy along with neurodevelopmental treatment. This study will improve the gross motor activities of children with hemiplegic cerebral palsy. It will broaden up the ways for physical therapist to deal with this type of cerebral palsy (hemiplegic).

Conditions

Cerebral Palsy; Hemiplegic Cerebral Palsy

Keywords

motor activity; spasticity; vestibular stimulation

Outcome Measures

Primary Outcomes (1)

• GMFM-88

  It is a Standardized Observational Instrument designed and validated to measure change in gross motor function over time in children with Cerebral Palsy. The GMFM-88 item scores can be summed to calculate raw and percent scores for each of the five GMFM dimensions of interest, selected goal areas and a total GMFM-88 score.

  12 weeks

Secondary Outcomes (1)

• Modified Ashworth Scale

  12 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

Neurodevelopmental Treatment. Total duration of treatment will be 20 minutes, 3 sessions per for 3 months

Other: Neurodevelopmental technique

Group B

EXPERIMENTAL

Neurodevelopmental Technique and Vestibular stimulation. Total duration of treatment will be 50 minutes (20 min NDT+ 30 MIN VS) 3 sessions per week for 3 months.

Other: Neurodevelopmental technique

Interventions

Neurodevelopmental technique OTHER

1. st month: postural maintenance; exercises with weight on forearms and hands, in sitting, crawling, semi-kneeling and standing positions with support from therapist. 2. nd month: balance and corrective reactions; using CP ball and tilt board. 3. rd month: ambulation training; appropriate to motor development level (crawling, creeping, walking in a semi-kneeling position and walking between parallel bars).

Group A; Group B

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 3 years to 12 years
• Gender: Both Male and female
• Children with Spastic Hemiplegic CP scoring 1,1+ and 2 on Modified Ashworth scale
• Level III and IV on GMFCS (Gross Motor Function Classification System)

You may not qualify if:

• Children with other types of Cerebral Palsy (diplegia, quadriplegia etc)
• Children with other Abnormalities and pathologies (delayed milestones, hydrocephalous, epilepsy etc)
• Children Undergone any kind of surgery (cardiac, shunt placement, orthopedic etc)
• Children with any other neurological deficits (spina bifida etc)
• Children with conditions in which vestibular stimulation is not allowed (paroxysmal positional vertigo or vestibular neuritis, Meniere's disease, migraine-associated vertigo, and childhood vertigo).

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Institute of Pediatric Habilitation and Rehabilitation IPH

Lahore, Punjab Province, Pakistan

Location

Related Publications (3)

• Tramontano M, Medici A, Iosa M, Chiariotti A, Fusillo G, Manzari L, Morelli D. The Effect of Vestibular Stimulation on Motor Functions of Children With Cerebral Palsy. Motor Control. 2017 Jul;21(3):299-311. doi: 10.1123/mc.2015-0089. Epub 2016 Aug 19.

  PMID: 27633076 BACKGROUND

• Bangash AS, Hanafi MZ, Idrees R, Zehra N. Risk factors and types of cerebral palsy. J Pak Med Assoc. 2014 Jan;64(1):103-7.

  PMID: 24605730 BACKGROUND

• Labaf S, Shamsoddini A, Hollisaz MT, Sobhani V, Shakibaee A. Effects of Neurodevelopmental Therapy on Gross Motor Function in Children with Cerebral Palsy. Iran J Child Neurol. 2015 Spring;9(2):36-41.

  PMID: 26221161 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mirza Obaid Baig, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 20, 2021
• Study Start: May 30, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)