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

NCT ID: NCT04894799

Last Updated: 2022-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-30
• Study Completion Date: 2022-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Cerebral Palsy; Hypotonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vestibular stimulation

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.

Group Type: EXPERIMENTAL

Vestibular stimulation

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Neck Control facilitation exercises

Intervention Type: 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.

Interventions

Vestibular stimulation

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.

Intervention Type: OTHER

Neck Control facilitation exercises

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mirza Obaid Baig

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Helping Hand Comprehensive Rehabilitation Center

Chakwal, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC/00983 Sadaf Zahra

Identifier Type: -

Identifier Source: org_study_id