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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Vestibular stimulation

Neck Control facilitation exercises

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring developmental milestones, hypotonia, vestibular stimulation

Eligibility Criteria

6 Months - 4 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Helping Hand Comprehensive Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vestibular stimulation

Neck Control facilitation exercises

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Infant Neurological International Battery

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04894799

First Posted

May 19, 2021

Last Updated

February 20, 2022

Sponsor

Riphah International University

1. Study Identification

Unique Protocol Identification Number

NCT04894799

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

May 30, 2021 (Actual)

Primary Completion Date

December 30, 2021 (Actual)

Study Completion Date

January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy, Hypotonia

Keywords

developmental milestones, hypotonia, vestibular stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vestibular stimulation

Arm Type

Experimental

Arm Description

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.

Arm Title

Neck Control facilitation exercises

Arm Type

Active Comparator

Arm Description

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

Intervention Name(s)

Vestibular stimulation

Intervention Description

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

Intervention Name(s)

Neck Control facilitation exercises

Intervention Description

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 Outcome Measure Information:

Title

Infant Neurological International Battery

Description

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.

Time Frame

10 weeks

Title

GMFM-88

Description

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.

Time Frame

10 weeks

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Self representation of gender identity

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

4 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mirza Obaid Baig

Organizational Affiliation

Riphah International University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Helping Hand Comprehensive Rehabilitation Center

City

Chakwāl

State/Province

Punjab

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

No

Cerebral Palsy, Hypotonia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial