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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Traditional physical therapy

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

NCT ID

NCT05763212

First Posted

February 28, 2023

Last Updated

February 28, 2023

Sponsor

Riphah International University

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

Cerebral Palsy

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