NCT05763212

Brief Summary

To determine the effects of reverse walking with and without Whole-body vibration on postural balance in children with cerebral palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

February 28, 2023

Last Update Submit

December 26, 2023

Conditions

Keywords

postural balance

Outcome Measures

Primary Outcomes (2)

  • Pediatric Balance Scale;

    The pediatric balance scale is the modified version of the berg balance scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points

    12th week

  • Pediatric Reach Test (PRT) / Functional Reach Test (FRT)

    The Pediatric Reach Test (PRT) is a modified form of the Functional Reach Test (FRT). The PRT measures side reaching as well as forward reaching in both sitting and standing positions.

    12th week

Secondary Outcomes (1)

  • CP QOL-Child

    12th week

Study Arms (2)

Reverse Walking+Baseline treatment

ACTIVE COMPARATOR

Conventional treatment was given then received Reverse Walking Training which was provided for 7 min per set, with approximately 3 min of inter-set rest, for a total training duration of 60 min/day, 3 days/week for 3 successive months .

Other: Reverse Walking+Baseline treatment

Whole Body Vibration + Reverse Walking+Baseline treatment

EXPERIMENTAL

Conventional Physical Therapy Treatment was given as a baseline treatment which includes Stretching, Range of motion exercises, and Strengthening exercises) performed for 10 min. Reverse Walking Training which was provided for 7 min per set, with approximately 3 min of inter-set rest, for a total training duration of 30 min/day, 3 days/week for 3 successive months After that Group received Whole Body Vibration including three vibration sessions per week for three months. The participants have to carry out each set of vibration for 2 min in the first month, and then it was increased to 3 min in the second and 5 min in the third month. The rest period between each set was 1 min in the first month, then it became half a minute in the second and third month. Total training duration is 30 min/day, 3 days/week for 3 successive months.

Other: Whole Body Vibration + Reverse Walking+Baseline treatment

Interventions

Reverse Walking+Baseline treatment

Reverse Walking+Baseline treatment

Whole Body Vibration + Reverse Walking+Baseline treatment

Whole Body Vibration + Reverse Walking+Baseline treatment

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 6-12 years
  • Confirm diagnosis of Cerebral Palsy
  • GMFCS level I \& II
  • Both genders (28)

You may not qualify if:

  • o Visual impairment
  • Patients who can't follow command
  • Hearing impairment
  • Malignancy
  • Infection (such as Osteomyelitis)
  • Inflammatory arthritis
  • Lower extremity bones fracture
  • Cardiovascular disease
  • Traumatic cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hussain memorial hospital lahore

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • fareeha kausar, pp-Dpt

    Riphah international university pakistan

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 10, 2023

Study Start

May 13, 2022

Primary Completion

March 16, 2023

Study Completion

March 30, 2023

Last Updated

December 29, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations