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Effects of TOT on Walking in Children With CP

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Task oriented training
Conventional rehabilitation treatment
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 Cerebral Palsy, Walking, Task oriented training, Conventional therapy, Balance

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Spastic CP children of age between 4 to 14 years
  • With spasticity 2 or less on Modified Ashworth scale
  • Who can walk (GMFCS level 1-3) and can
  • Can perform different activities on command

Exclusion Criteria:

  • Children with cognitive impairment
  • Lower limb surgery in last 6 months
  • Tetraplegic CP and who are unable to walk and follow command

Sites / Locations

  • Armed Forces Institute of Rehabilitation Medicine (AFIRM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Task-oriented training (TOT)

Conventional rehabilitation treatment

Arm Description

Task-oriented training consisted of different functional tasks for lower limbs to improve balance and walk

Conventional rehabilitation treatment includes mat activities and range of motion (ROM) of all limbs, Lower limb strengthening and stretching, walking, cycling

Outcomes

Primary Outcome Measures

Timed Up and Go test (TUG)
A line was marked on floor at a distance at a distance of 3 meters (9.8 feet) leveled walking. A score of 30 seconds or more suggests that the person may be prone to falls. Alternatively, a recommended practical cut-off value for the TUG to indicate normal versus below normal performance is 12 seconds.
Functional Walking Test (FWT)
The purpose of function walk test is to evaluate the walking balance and functional walking ability of a child. It has 5 main components. With different scores each, that is 3, 2 and 1. Also it specifies if there is any asymmetry between Right and Left lower limb and better limb functioning is recorded. Total score of FWT is 23 points
Modified Ashworth scale (MAS)
The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform. A score of 1 indicates no resistance, and 5 indicates rigidity.
Gross Motor Function Classification System (GMFCS)
GMFCS divides the CP children into 5 levels, where level 1 is the least affected and most functional children and level 5 most affected and least functional.

Secondary Outcome Measures

Full Information

First Posted
September 17, 2020
Last Updated
September 22, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04561349
Brief Title
Effects of TOT on Walking in Children With CP
Official Title
Effects of Task Oriented Training on Walking in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 30, 2019 (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
No

5. Study Description

Brief Summary
The purpose of the study was to determine the effects of task oriented training (TOT) on walking and balance in children with spastic Cerebral Palsy (CP).
Detailed Description
The aim of study is to evaluate the effectiveness of task-oriented training on the walking in Cerebral Palsy children and compare its results with that of the conservative rehabilitation treatment. By training children to walk using task oriented training not only improves their walk and balance but also encourage them to actively participate in their own treatment process. Task oriented training approach can prove to be an effective technique for those CP children who can perform ambulation and have defined targets for gross motor activities

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Walking, Task oriented training, Conventional therapy, Balance

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Task-oriented training (TOT)
Arm Type
Experimental
Arm Description
Task-oriented training consisted of different functional tasks for lower limbs to improve balance and walk
Arm Title
Conventional rehabilitation treatment
Arm Type
Active Comparator
Arm Description
Conventional rehabilitation treatment includes mat activities and range of motion (ROM) of all limbs, Lower limb strengthening and stretching, walking, cycling
Intervention Type
Other
Intervention Name(s)
Task oriented training
Intervention Description
Task oriented training consisted of different functional tasks for lower limbs to improve balance and walk. Each task was given 5 minutes Tasks were progressed according to each child's performance. These progressions included increase of repetitions, speed and switching between the tasks. One hour practice of these tasks was advised for home plan
Intervention Type
Other
Intervention Name(s)
Conventional rehabilitation treatment
Intervention Description
Conventional rehabilitation treatment includes mat activities and ROM of all limbs, Lower limb strengthening and stretching, walking, cycling. Each exercise was performed for 5 minutes. One hour practice of above exercises and thermotherapy for the spastic muscles advised for 10 minutes once a day at home was advised.
Primary Outcome Measure Information:
Title
Timed Up and Go test (TUG)
Description
A line was marked on floor at a distance at a distance of 3 meters (9.8 feet) leveled walking. A score of 30 seconds or more suggests that the person may be prone to falls. Alternatively, a recommended practical cut-off value for the TUG to indicate normal versus below normal performance is 12 seconds.
Time Frame
6th week
Title
Functional Walking Test (FWT)
Description
The purpose of function walk test is to evaluate the walking balance and functional walking ability of a child. It has 5 main components. With different scores each, that is 3, 2 and 1. Also it specifies if there is any asymmetry between Right and Left lower limb and better limb functioning is recorded. Total score of FWT is 23 points
Time Frame
6th week
Title
Modified Ashworth scale (MAS)
Description
The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform. A score of 1 indicates no resistance, and 5 indicates rigidity.
Time Frame
6th week
Title
Gross Motor Function Classification System (GMFCS)
Description
GMFCS divides the CP children into 5 levels, where level 1 is the least affected and most functional children and level 5 most affected and least functional.
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Spastic CP children of age between 4 to 14 years With spasticity 2 or less on Modified Ashworth scale Who can walk (GMFCS level 1-3) and can Can perform different activities on command Exclusion Criteria: Children with cognitive impairment Lower limb surgery in last 6 months Tetraplegic CP and who are unable to walk and follow command
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazish Rafique, MSPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Armed Forces Institute of Rehabilitation Medicine (AFIRM)
City
Rawalpindi
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of TOT on Walking in Children With CP

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