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Reverse Walking With And Without Whole Body Vibration in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Traditional physical therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring postural balance

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 6-12 years Confirm diagnosis of Cerebral Palsy GMFCS level I & II Both genders (28) Exclusion Criteria: 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

Sites / Locations

  • Hussain memorial hospital lahoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Reverse Walking+Baseline treatment

Whole Body Vibration + Reverse Walking+Baseline treatment

Arm Description

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 .

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

CP QOL-Child
The CP QOL-Child was designed to assess the quality of life of children aged 4-12 years. There are two versions, including a primary caregiver/parent report for children aged 4 to 12 years; and a self-report for children aged 9 to 12 years(10). GMFCS level I & II GMFCS Level I

Full Information

First Posted
February 28, 2023
Last Updated
February 28, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05763212
Brief Title
Reverse Walking With And Without Whole Body Vibration in Children With Cerebral Palsy
Official Title
Effects Of Reverse Walking With And Without Whole Body Vibration On Postural Balance And Quality Of Life In Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
March 16, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

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
No

5. Study Description

Brief Summary
To determine the effects of reverse walking with and without Whole-body vibration on postural balance in children with cerebral palsy.
Detailed Description
Current study concluded that reverse walking with and without whole body vibration were effective in improving postural balance, reach and quality of life in cerebral palsy children. However (whole body vibration+ reverse walking) provides more clinical benefits than reverse walking alone in improving postural balance, side reach and quality of life. Whereas both techniques were equally effective in improving forward reach in cerebral palsy children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
postural balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reverse Walking+Baseline treatment
Arm Type
Active Comparator
Arm Description
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 .
Arm Title
Whole Body Vibration + Reverse Walking+Baseline treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional physical therapy
Other Intervention Name(s)
Whole body vibration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pediatric Balance Scale;
Description
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
Time Frame
12th week
Title
Pediatric Reach Test (PRT) / Functional Reach Test (FRT)
Description
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.
Time Frame
12th week
Secondary Outcome Measure Information:
Title
CP QOL-Child
Description
The CP QOL-Child was designed to assess the quality of life of children aged 4-12 years. There are two versions, including a primary caregiver/parent report for children aged 4 to 12 years; and a self-report for children aged 9 to 12 years(10). GMFCS level I & II GMFCS Level I
Time Frame
12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 6-12 years Confirm diagnosis of Cerebral Palsy GMFCS level I & II Both genders (28) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mishal Shansi, MS
Phone
03319773117
Email
mishalshamsi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fareeha kausar, pp-Dpt
Organizational Affiliation
Riphah international university pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hussain memorial hospital lahore
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Reverse Walking With And Without Whole Body Vibration in Children With Cerebral Palsy

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