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NCT Number: NCT04894799

Vestibular Stimulation and Neurodevelopmental Technique on Hypotonic Cerebral Palsy While Controlling the Gender

there is no such article found who specifies the effects of sensory integration therapies like vestibular stimulation technique or developmental milestone while controlling the gender of children with cerebral palsy. So, there is a need to do more research work on this in future to find out best treatment approach for children with cerebral palsy of their respective gender. That is why this study will focus on the results of vestibular stimulation and neurodevelopmental technique while controlling the Gender distribution of both intervention groups to find out the effects of these interventions that wither, they have some influence on the participants or not.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Hypotonia Muscle Hypotonia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helping Hand Comprehensive Rehabilitation Center

Chakwal, Punjab Province, Pakistan

About this study

Bobath concept of neurodevelopment in children with cerebral palsy, is a problem-solving approach to the assessment and treatment of individuals with disturbances of tone, movement, and function due to a lesion of CNS, the goal of treatment is to optimize function by improving postural control and selective movement through facilitation. But also, no study found which specifically focuses the improvements on boys and girl's ratio or their gender-based improvements of tone or developmental milestones.

Different swings such as Infant Swing, frog swing, platform swing will be included as mode of Vestibular stimulation treatment. On the other side, Stimulation of vestibular system improved child's postural control and motor function in many studies.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hypotonic CP
  • GMFM-88 ranges: With true score of zero (0) = does not initiates i.e., head control absent at age of 6 months
  • Tone: 6 months infants total scoring ≤ 54 and 8 month or more total scoring ≤ 68 on Infant Neurological international Battery Scoring Sheet will be included.

Exclusion criteria

  • Children with other Abnormalities and pathologies like Down syndrome, Joubert Syndrome
  • Children Undergone any kind of surgery like reconstruction surgeries for congenital defects of eyes, head, neck or all four limbs of the body
  • Children with other type of Cerebral Palsy (CP) like Spastic (Hypertonic), Choreoathetoid, Dystonic, Ataxia, Athetoid and mixed CP
  • Children with any other neurological deficits, Mentally Challenged.

Treatment and study plan

vestibular stimulation

Other

In Vestibular Stimulation (VS) group, all participants will be given Infant Swing activity for one hour, trice a day for first 4 weeks. After that, in 5th and 6th weeks, all participants will be given Infant Swing for 30 minutes and frog swing for 30 minutes for two weeks. Next 7th and 8th weeks, Infant Swing (30 minutes) and prone on frog swing feet touching the floor (30 minutes), trice a day will be applied. In 9th week, Infant swing and normal playground swing for 30,30 minutes will be given to all participants, trice a day. In Last week of intervention i.e., 10th week, all participants will be given Infant Swing for 30 minutes and standing on platform swing (30 minutes) trice a day.

Neck Control facilitation exercises

Other

all participants will be given Neck Control facilitation exercises using Bobath Approach of low tone facilitation method, for one hour, trice a day for first 4 weeks. After that, in 5th and 6th weeks, all participants will be given Neck Control facilitation exercises for 30 minutes and sitting facilitation Exercises with trunk weight shifting for 30 minutes, trice a day. Next 7th and 8th weeks, Neck Control facilitation exercises (30 minutes) and sitting facilitation exercises with trunk weight shifting and kneeling weight bearing (30 minutes), trice a day will be applied. In 9th and 10th weeks, Neck Control facilitation exercises, sitting and kneeling weight bearing and standing with trunk elongation will be given to all participants for one hour, trice a day.

Primary outcomes

  1. Infant Neurological International Battery

    Time frame: 10 weeks

    Infant Neurological International Battery ( INFANIB) is the developmental screening tool used for the assessment of neuromotor development in neonates and infants aged 1-18 months. The score of each item is mentioned in the score sheet itself based upon age and calculating total score will determine the neuromotor state of infants.

  2. GMFM-88

    Time frame: 10 weeks

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Vestibular Stimulation and Neurodevelopmental Technique on Hypotonic Cerebral Palsy While Controlling the Gender

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 20, 2021
Registry last updated
Feb 22, 2022

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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