NCT04087330

Brief Summary

To target spasticity, balance and mobility whole body vibration exercises along with selected physical therapy is given to experimental group. Control group will receive only selected physical therapy that includes sstretching exercises, gait training, ffacilitation of postural reactions, ffacilitation of standing and weight shift and facilitation of standing balance by using a balance board.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

November 10, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

September 4, 2019

Last Update Submit

November 8, 2021

Conditions

Cerebral Palsy, Spastic

Keywords

Cerebral PalsySpasticWhole body vibration

Outcome Measures

Primary Outcomes (3)

  • Modified Ashworth

    It is used to check spasticity and consists of 6 grades from 0-4

    Change from Baseline spasticity to 3 months

  • 6-Minute walking test (6MWT)

    It is used to test mobility of participant. The 6-minute walk test (6MWT) is a standardized, self-paced walking test commonly used to assess functional ability in different populations.

    Change from Baseline mobility level to 3 months

  • Paediatric Balance Scale

    The Pediatric Balance Scale (PBS), a modification of the BBS, was developed as a balance measure for children with mild to moderate motor impairments and has good test-retest and interrater reliability. The PBS is a 14-item, criterion-referenced measure and examines functional balance in the context of everyday tasks

    Change from Baseline balance to 3 months

Secondary Outcomes (2)

  • Timed Up and Go test (TUG)

    Change from Baseline mobility and balance to 3 months

  • Sit-To-Stand (STS) test

    Change from Baseline mobility and balance to 3 months

Study Arms (2)

Group 1 Experimental group

EXPERIMENTAL

Stretching, facilitation exercises with whole body vibration

Other: Group 1 Experimental group

Group 2 Control group

ACTIVE COMPARATOR

Stretching and facilitation exercises

Other: Group 2 Control group

Interventions

Group 1 Experimental groupOTHER

Stretching exercises for Achilles tendon, hamstrings, hip flexors and adductors of lower limbs, upper abdominal and pectoralis muscles. Facilitation of postural reactions, including: facilitation of righting, equilibrium and protective reactions from sitting on ball. Facilitation of standing and weight shift. Facilitation of standing balance by tilting the child from standing to different directions (forward, back-ward and side-way) using a balance board. Gait training: by forward, backward, and side-way walking between parallel bars. Whole body vibration.

Group 1 Experimental group
Group 2 Control groupOTHER

Stretching exercises for Achilles tendon, hamstrings, hip flexors and adductors of lower limbs, upper abdominal and pectoralis muscles. Facilitation of postural reactions, including: facilitation of righting, equilibrium and protective reactions from sitting on ball. Facilitation of standing and weight shift. Facilitation of standing balance by tilting the child from standing to different directions (forward, back-ward and side-way) using a balance board. Gait training: by forward, backward, and side-way walking between parallel bars.

Group 2 Control group

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ashworth scale score +1-3
  • age between 6 and 13 years,
  • able to accept and follow verbal instructions,
  • Gross Motor Function Classification System \[GMFCS\] levels I-III),

You may not qualify if:

  • unstable seizures, any treatment for spasticity or surgical procedures from 3 months (for botulinum toxin type A injections)
  • Suffering from any other condition that interfered with physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Federal, 46000, Pakistan

Location

Related Publications (6)

  • Cheng HY, Ju YY, Chen CL, Chuang LL, Cheng CH. Effects of whole body vibration on spasticity and lower extremity function in children with cerebral palsy. Hum Mov Sci. 2015 Feb;39:65-72. doi: 10.1016/j.humov.2014.11.003. Epub 2014 Nov 24.

    PMID: 25461434BACKGROUND

  • Dickin DC, Faust KA, Wang H, Frame J. The acute effects of whole-body vibration on gait parameters in adults with cerebral palsy. J Musculoskelet Neuronal Interact. 2013 Mar;13(1):19-26.

    PMID: 23445911BACKGROUND

  • Saquetto M, Carvalho V, Silva C, Conceicao C, Gomes-Neto M. The effects of whole body vibration on mobility and balance in children with cerebral palsy: a systematic review with meta-analysis. J Musculoskelet Neuronal Interact. 2015 Jun;15(2):137-44.

    PMID: 26032205BACKGROUND

  • Unger M, Jelsma J, Stark C. Effect of a trunk-targeted intervention using vibration on posture and gait in children with spastic type cerebral palsy: a randomized control trial. Dev Neurorehabil. 2013;16(2):79-88. doi: 10.3109/17518423.2012.715313.

    PMID: 23477461BACKGROUND

  • Matute-Llorente A, Gonzalez-Aguero A, Gomez-Cabello A, Vicente-Rodriguez G, Casajus Mallen JA. Effect of whole-body vibration therapy on health-related physical fitness in children and adolescents with disabilities: a systematic review. J Adolesc Health. 2014 Apr;54(4):385-96. doi: 10.1016/j.jadohealth.2013.11.001. Epub 2014 Jan 1.

    PMID: 24388109BACKGROUND

  • Yeargin-Allsopp M, Van Naarden Braun K, Doernberg NS, Benedict RE, Kirby RS, Durkin MS. Prevalence of cerebral palsy in 8-year-old children in three areas of the United States in 2002: a multisite collaboration. Pediatrics. 2008 Mar;121(3):547-54. doi: 10.1542/peds.2007-1270.

    PMID: 18310204BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Misbah Ghous, MSNMPT*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2019

First Posted

September 12, 2019

Study Start

September 15, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

November 10, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)